Pfizer
Gastrointestinal symptom reports
Female, 60 - 75 years
| Age | Reported | Symptoms | Notes |
|---|---|---|---|
| 60 | 2021-01-01 | difficulty swallowing, nausea |
Dizziness, nausea, sweating, throat swelling, hard to swallow, dry mouth, headache, shaky, feeling h...
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Dizziness, nausea, sweating, throat swelling, hard to swallow, dry mouth, headache, shaky, feeling hot/cold
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| 60 | 2021-01-01 | vomiting |
Starting at 0100 am I noticed chills, body aches, vomited, then felt crappy all day. Thursday night ...
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Starting at 0100 am I noticed chills, body aches, vomited, then felt crappy all day. Thursday night 12/31 symptoms worsened with above & headache
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| 60 | 2021-01-03 | diarrhea, nausea, abdominal discomfort |
12/18/20 08:00PM Mild headache; 12/19/20 headache resolved; chills, loose bowel movement, fatigue. ...
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12/18/20 08:00PM Mild headache; 12/19/20 headache resolved; chills, loose bowel movement, fatigue. 12/20/20 loose bowel movement, rash on back and disappeared face red lips swollen. 12/21/20 symptoms continued medications taken Benadryl. Imodium; rash resolved and loose bowel movements later in the day. Abd discomfort, pain and nausea present since vaccine given.
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| 60 | 2021-01-03 | nausea, vomiting | Debilitating frontal headache, accompanied by nausea and vomiting, and fatigue for 16 hours |
| 60 | 2021-01-03 | nausea | Flu-like symptoms - nausea, sweat. Arm sore immediately after injection - sore for 2 days. |
| 60 | 2021-01-03 | vomiting |
* Had sore arm at the vaccine site * Headache began at 7 pm on 3-Jan * Had chills during the night, ...
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* Had sore arm at the vaccine site * Headache began at 7 pm on 3-Jan * Had chills during the night, cold and unable to get warm even with multiple blankets * Severe dizziness and vomiting * Headache not relieved by Ibuprofen; took 25 mg Benadryl at midnight
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| 60 | 2021-01-04 | abdominal pain lower, nausea |
nausea/waves of nausea; lower abdominal pain; headache; This is a spontaneous report from a contacta...
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nausea/waves of nausea; lower abdominal pain; headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (BNT162B2; reported as COVID19 Vaccine; lot number: EJ1685; expiration date: Mar2021), via an unspecified route of administration right arm on 18Dec2020 15:00 at single dose for Covid-19 vaccination. Medical history included IBS (irritable bowel syndrome), hysterectomy at age 42 and she doesn't have periods (amenorrhea). The patient family medical history included her family are all dead and has been for a long time. The patient's concomitant medications were not reported. It was reported that vaccinations within 4 weeks included shingles vaccination 5 weeks before covid-19 vaccine wherein the patient first singles shot was fine. Her second shingles shot made her sick, body aches, and fever for about 24 hours. She received it from a pharmacy inside a store. The reporter mentioned that she took her first covid vaccine shot and was able to experience nausea, headache lower abdominal pain. She inquired if there was information on until when she will be experiencing this or how long the symptoms will last. She mentioned that she had headaches and waves of nausea, and before nausea, she had lower abdominal pain. She doesn't know if abdominal pain was coincidental. She had a hysterectomy, so she doesn't have periods. She lives with IBS, but this abdominal pain was different. Immediately after COVID-19 Vaccine within about 20 minutes after injection (18Dec2020 15:20), she had headaches and she still has been having headaches. She had strange lower abdominal pain that lasted a minute and a half then shortly after that started having waves of nausea. She added that the waves of nausea began 24 hours after the COVID-19 Vaccine (19Dec2020 15:00). The outcome of the event headache was not recovered, as for nausea was unknown while the outcome of the other event was recovered on Dec2020.
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| 60 | 2021-01-04 | vomiting, abdominal discomfort, diarrhea |
Palpitations; Weakness; sore throat; Burning sensation and the soreness in tongue; Burning sensation...
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Palpitations; Weakness; sore throat; Burning sensation and the soreness in tongue; Burning sensation and the soreness in tongue; vomiting severely 5 times; could not eat and breathe; could not eat and breathe; abdomen was upset; cramps and pain; cramps and pain; diarrhea; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the receive bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration on 21Dec2020 at 60-years-old at a single dose for COVID-19 immunization. Medical history included high cholesterol from an unknown date and unknown if ongoing. Concomitant medications included rosuvastatin calcium (CRESTOR) taken for high cholesterol from an unspecified date to an unspecified date. The patient experienced the following events and outcomes: palpitations (non-serious) on 22Dec2020 with outcome of unknown , weakness (non-serious) on 22Dec2020 with outcome of unknown, sore throat (non-serious) on 22Dec2020 with outcome of unknown, burning sensation and the soreness in tongue (non-serious) on 22Dec2020 with outcome of unknown, vomiting severely 5 times (non-serious) in Dec2020 with outcome of unknown, could not eat and breathe (non-serious) in Dec2020 with outcome of unknown, abdomen was upset (non-serious) in Dec2020 with outcome of unknown, cramps and pain (non-serious) in Dec2020 with outcome of unknown, diarrhea (non-serious) in Dec2020 with outcome of unknown. The nurse stated she received the COVID vaccine on 21Dec2020. The nurse stated she did not have any adverse reaction immediately on the first day but on the second day, after 24 hours, she started to have "little bit palpitations that too for a short period of time and a little bit weakness for a short period of time and sore throat. It is not just soring or swelling but it is burning sensation and, on my tongue, also I feel the same thing, burning sensation and the soreness. That was for a small period of time but on my tongue, it is still there, and my throat is still there and last night I experienced vomiting severely 5 times. After the vomiting, I could not eat and breathe." Then, the nurse slept about 3-5 hours, and woke up and her abdomen was upset. The nurse had cramps and pain and when she went to the bathroom and she had huge diarrhea, 2 times."
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| 60 | 2021-01-04 | vomiting |
Vomiting, chills, headache. Began 18 hours post injection. Lasted for 12 hours. Continued to have ch...
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Vomiting, chills, headache. Began 18 hours post injection. Lasted for 12 hours. Continued to have chills and excessives sleepiness for 48 hours.
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| 60 | 2021-01-05 | nausea |
INJECTION SITE REDNESS, NAUSEA, FEELING UNWELL, HEADACHE, FAST HEART BEAT, SLIGHT ITCHING, DIZZINES...
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INJECTION SITE REDNESS, NAUSEA, FEELING UNWELL, HEADACHE, FAST HEART BEAT, SLIGHT ITCHING, DIZZINESS, TIREDNESS, MUSCLE PAIN, CHILLS ALL BY 13:30PM AND LASTED FROM 1.04.21 AND CURRENTLY ON 1.06.21 STILL TIRED, DIZZY, HEADACHE, CHILLS AND ITCHY BUT IS BETTER THAN ON 1.04.21.
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| 60 | 2021-01-05 | nausea |
Dizzy right after vaccine, foggy increased through evening, tired in the evening of injection, muscl...
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Dizzy right after vaccine, foggy increased through evening, tired in the evening of injection, muscle aches, headache, and nausea about 2am, fever 99.8 at 1pm on 1/6/21. All these symptoms still persist now 5:40pm 1/6/20
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| 60 | 2021-01-05 | nausea |
19th received Covid Vaccine at noon 21st negative Covid surveillance test completed due to ED Clust...
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19th received Covid Vaccine at noon 21st negative Covid surveillance test completed due to ED Cluster 22nd Bedtime approx. 2100 A very strange feeling of overwhelming fatigue "spacey feeling"" 23rd nausea dizzy general malaise 24th nausea dizzy general malaise 25th nausea dizzy general malaise Contacted Health Service 26th still nauseous dizzy general malaise and then chills Health Service Ordered Covid Test 26th negative Covid. 26th video appointment with PCP states no need for labs feels it's Vaccine related 27th minimal nausea no chills episodes of feeling ?spacey? and tired 28th Minimal nausea 29th Morning nausea and fatigue 30th Morning nausea and fatigue 31st increased nausea and fatigue all day easing as day progresses "spacey" with fatigue
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| 60 | 2021-01-05 | nausea |
Felt mildly fluish by end of working shift (1130 pm), arm became more sore, unable to lay on it in b...
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Felt mildly fluish by end of working shift (1130 pm), arm became more sore, unable to lay on it in bed. Woke up in middle of night with body aches , chills and headache. By 10 am felt increase in flu like symptoms, mild nausea, swollen glands, mouth cold sore and red hot face. Temp was 101.2. All joints hurt, general malaise.
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| 60 | 2021-01-06 | diarrhea | Severe Body aches cough fever 100.8 chills diarrhea |
| 60 | 2021-01-06 | nausea |
12 hours post injection 7:30p, low grade fever 99F, queasy, brain fog and exhaustion. Fever went awa...
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12 hours post injection 7:30p, low grade fever 99F, queasy, brain fog and exhaustion. Fever went away over night, the rest of the symptoms stayed through the day.
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| 60 | 2021-01-06 | retching, decreased appetite |
Received 2nd dose at 10:30 am at Hospital. I went to work as usual at 1:45 pm though 10:00 pm. wit...
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Received 2nd dose at 10:30 am at Hospital. I went to work as usual at 1:45 pm though 10:00 pm. without any issues. Came home, had 2 glasses of wine, as usual, at 1:00 a.m. feeling body aches and headache continued sleeping, woke up at 9:00 a.m. with dry heaves with phlegm with small streaks of blood, rapid heart rate, fatigue with body aches, pain in location of injection, occasional headache, loss of appetite. The body aches, fatigue continued the following day, appetite returned slightly. Thankful these were my scheduled days off from work. Third day after injection body aches dissipating able to go out of the house to do errands.
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| 60 | 2021-01-07 | abdominal pain, diarrhea, nausea |
Sudden onset nausea; Swelling at injection site.; abdominal cramps; single episode loose stool; This...
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Sudden onset nausea; Swelling at injection site.; abdominal cramps; single episode loose stool; This is a spontaneous report from a contactable nurse, the patient. A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL0140), via an unspecified route of administration on 30Dec2020 at 09:15 (at the age of 60-years-old) as a single dose, in the right arm for COVID-19 vaccination. Medical history included lymphedema, lipedema, depression, osteoporosis, osteoarthritis, hypothyroid, malabsortion with vitamin deficiencies, anemia, and allergy to latex. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported, however it was reported the patient received other medications (unspecified) within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took thimerisol and influenza vaccine both from unknown dates to unknown dates for unknown indications and experienced allergy. On 30Dec2020 at 10:00, the patient experienced sudden onset nausea, abdominal cramps, single episode loose stool, and swelling at injection site. The patient did not receive any treatment for the events. The clinical outcome of the events sudden onset nausea, abdominal cramps, single episode loose stool, and swelling at injection site was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 60 | 2021-01-07 | abdominal pain | Chest pain Abdominal pain Fever, severe chills, diaphoresis Seizure like activity for two night |
| 60 | 2021-01-07 | diarrhea, nausea |
very dizzy/ felt like her Blood pressure dropped/she felt like she was going to faint; she felt real...
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very dizzy/ felt like her Blood pressure dropped/she felt like she was going to faint; she felt really really sick/ didn't feel good/felt very bad; Sweating; Nauseous; loose stool; her injection site had a lump and was red; a little pain in her arm/ it was just a little sore; her injection site had a lump and was red; This is a spontaneous report from a contactable consumer reporting for herself. A 60-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiration date not provided) via an unspecified route of administration on 29Dec2020 11:30 at single dose in the arm for COVID-19 immunization. There were no relevant medical history and no concomitant medications. The patient received the vaccine 29Dec2020 at 11:30 am. She went to work at 11 at night and only had a little pain in her arm. At 4 am on 30Dec2020, she felt really sick. She felt like her blood pressure dropped. She was very dizzy. She was scared. She didn't feel good. She felt like she was going to faint and was sweating. She was going to try to finish her work and go home. She went to the house, and was very sick. She got into bed because she believed she needed rest. At 3 pm on 30Dec2020, nothing was wrong. She was going to rest more. That night time on 30Dec2020, she felt better. She had also got nauseous. She stated the symptoms only lasted a day, and also said the side effects only lasted from 4 o'clock to 8 o'clock when she got home. She did go to the bathroom and experienced loose stool. She felt very bad when she laid down in bed. By 10 o'clock pm (30Dec2020) she felt better. The patient said she had no problem moving her arm as it was just a little sore. When she got home from work her husband noticed her injection site had a lump and was red. Her arm recovered in a week's time. The patient stated she would go for her second shot on 13Jan2021. The symptoms which started on 30Dec2020 04:00 (dizzy/felt like her blood pressure dropped/she felt like she was going to faint, feeling sick/bad, sweating, nauseous, loose stool) were resolved on 30Dec2020. The events pain in her arm and injection site lump and red were resolved on an unspecified date in Jan2021. Information about lot and batch number was requested.
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| 60 | 2021-01-07 | diarrhea | Diarrhea Headache Narrative: |
| 60 | 2021-01-07 | nausea |
Significant nausea that came on about 24 hours after the injection. No vomiting. Symptoms are signif...
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Significant nausea that came on about 24 hours after the injection. No vomiting. Symptoms are significantly improved and subsiding at the time of this report.
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| 60 | 2021-01-08 | nausea, vomiting | SkinRash & NauseaVomiting |
| 60 | 2021-01-09 | diarrhea |
Chills, extreme weakness, and excruciating bone and muscle pain, diarrhea lasting 48 hours. Improve...
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Chills, extreme weakness, and excruciating bone and muscle pain, diarrhea lasting 48 hours. Improved with Meloxicam. The keratitis flared up. Developed keratitis after the first dose on 12/17/2020. Lot EK5730. The keratitis presented with dry eyes, photophobia and reduced reading ability. I am treated with steroid drops and artificial tears.
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| 60 | 2021-01-10 | decreased appetite, nausea | nausea,weakness,chills , fever , muscle and joint pain , no appetite |
| 60 | 2021-01-10 | diarrhea |
Muscle and joint weakness with chest muscle pain x 5 days hurts all over and worse when gets up and ...
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Muscle and joint weakness with chest muscle pain x 5 days hurts all over and worse when gets up and moves. Diarrhea started 1-5-2021. No fever 97.7. Off work for 4 days. Using heating pad and inhalers. Has appointment with provider 1-5-2021 and 1-7-2021. Test for COVID on 1-7-2021 and negative Symptoms resolved 1-9-2021 and returned to work on 1-11-2021
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| 60 | 2021-01-10 | diarrhea |
four hours after receiving vaccine, I experienced diarrhea, then fever. Weakness, fatigue and incre...
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four hours after receiving vaccine, I experienced diarrhea, then fever. Weakness, fatigue and increased fever continued thru the night and not able to sleep, very restless. The next morning after I had more weakness and major flair up with my MS, where I fell several times and was not able to get myself off the floor. Each time I fell it too approximately 20 minutes for me to get either in bed or a chair. Still had fever of a 100-101 through out the day, took ibuprofen to help, which it did for a short time but then fever was back. About 7pm I took some Benadryl and was finally able to fall asleep. The next morning, no fever but very weak. Went to health club to help with my legs. This day was ok, weak but improved. No falls
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| 60 | 2021-01-10 | difficulty swallowing |
Pfizer-BioNTech COVID-19 Vaccine EUA: Soon after receiving vaccination patient became tired and expe...
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Pfizer-BioNTech COVID-19 Vaccine EUA: Soon after receiving vaccination patient became tired and experienced a headache. The next day at 2:15pm the patient reported a temperature of 99.0 degrees Fahrenheit, not being as tired, but starting at 9:30 am that morning experiencing "tongue being tied" and having difficulty communicating described as "know what they want to say but it... doesn't come out" that lasted three hours. The patient denied problems walking or being confused. The patient was immediately referred to the emergency department for evaluation. Upon arrival to the emergency department patient had clear speech speaking in complete sentences and ambulating independently with a steady gait. Physical and neurological exams both normal: no aphasia and no focal neurological deficits, normal strength and sensation throughout. Initial vital signs within normal ranges except blood pressure 149/88 mmHg. Patient remained asymptomatic and stable throughout emergency department stay. Repeat vital signs were within normal ranges and patient was discharged to home with a diagnosis of transient ischemic attack. On follow-up visit with primary care physician four days after vaccination patient reports feeling much better and no new symptoms reported.
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| 60 | 2021-01-10 | nausea |
dizziness around 8:00pm, fatigue, severe headache, neck & shoulder pain, body aches, joint pain, nau...
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dizziness around 8:00pm, fatigue, severe headache, neck & shoulder pain, body aches, joint pain, nauseous, mild shortness of breath
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| 60 | 2021-01-10 | nausea | Fever 102.2, chills, body aches, nausea. |
| 60 | 2021-01-10 | nausea |
Looked like an encephalopathy; Face was all swollen; Head swelled; Glands swelled; Fatigue; Headache...
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Looked like an encephalopathy; Face was all swollen; Head swelled; Glands swelled; Fatigue; Headache/ So much pain in my head; Couldn't talk; Complete brain fog; nausea; This is a spontaneous report from a contactable nurse. This 60-year-old female nurse (Patient) reported that received bnt162b2 (BNT162B2, Pfizer COVID-19 vaccine), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunisation. Medical history included Atrial fibrillation, Chronic Lyme, Lupus and Autoimmune. Concomitant medications included Metoprolol at 12.5 mg for Atrial fibrillation and acetylsalicylic acid (BABY ASPIRIN). No diabetes, no hypertension. None of the usual common diseases. Registered Nurse stated, "I received vaccine this past Wednesday. I was just talking to a couple of my colleagues and honestly I received the vac. at work. I did not really read through the paperwork and was 'weird' sharing reactions to the vaccine which for me was pretty bad reaction and thought like I need to go through your paperwork and report it. So I thought I should call and just give some information. The usual fatigue which I go to after being normal, my arm was not sore. However, as the week progressed into Friday I had a constant headache but it was manageable and then by Friday night my glands swelled, my nerves behind my ears, my neck and I was extremely fatigued, bad headache and went to bed and I had not gone out and finally I got out today I spoke with my Physician yesterday. What happened it looked like an encephalopathy but my head swelled, my face was all swollen, complete brain fog, fatigue and I couldn't talk. I was in so much pain in my head resulting in (incomplete sentence)." Lab work included the only thing is the PCR swabbing. No blood test. Registered Nurse further stated, "I don't know if that is important. But I will tell you and if it is you can send me the questions. I do have a history of Autoimmune. So my Physician thought that this was just like an enhancement of like my bodies reaction I have Chronic Lyme and I have lupus like my ANA has always been stressful. But we think that it is a family thing. No treatment for the Lyme. I did a lot of antibiotic and a lot of naturopathic stuff but that is in the past. But anyhow for anything else what I did was when I got the injection they said try and just take Tylenol not Ibuprofen but there was no way I was going to make it through with just that . So I took Ibuprofen. I called my Physician yesterday morning because I was not sure about what was is happening and I thought it might be secondary sinus infection or something else going on and it reassured me that it is definitely due to the vaccine. He said it is just your body's reaction, take the Ibuprofen, hydrate. Had me take what I had in my house Tigan for nausea. So I was extremely nauseous from the severity of the headache." Registered Nurse stated, "I just wanted to let you know what happened and the intensity of what it was because normally I would expect a headache. But this was a 'go dated'. Registered Nurse stated, "I guess the only question that I have is so do my work has this question and I was going to call my doctor tomorrow may be might know it better. I know that I have to take the second dose. But I understand the second round can be worse than the first. Is there anything that they are recommending that I can do may be prior to ease the reaction?" The outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: The reported clinical manifestations including swelling face and head swelled, which was suspected as encephalopathy by the reporting nurse, was probably related to the bnt162b2 (BNT162B2, Pfizer COVID-19 vaccine), due to temporal relationship. The subject's underlying Chronic Lyme, Lupus and Autoimmune were likely the risk factors to the onset of the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees and Investigators, as appropriate.
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| 60 | 2021-01-11 | nausea |
Arm pain; Full body aches; Headaches; Frequent bathroom use (not diarrhea more of a mix); Mild wheez...
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Arm pain; Full body aches; Headaches; Frequent bathroom use (not diarrhea more of a mix); Mild wheezing; Nausea; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 05Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing asthma (asthmatic) which had been under control for years. The patient's concomitant medications were not reported. In Jan2021, the patient had arm pain; full body aches; headaches; had frequent bathroom use (not diarrhea "more of a mix"); mild wheezing; and nausea. The patient had received paracetamol (TYLENOL) as treatment for the arm pain. The outcome of the events, 'arm pain', 'full body aches', 'headaches', 'frequent bathroom use', 'mild wheezing' and 'nausea', was unknown. Information on the lot/batch number has been requested.
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| 60 | 2021-01-11 | nausea |
developed nausea and light headedness approximately 6 hours post vaccine. patient unable to report ...
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developed nausea and light headedness approximately 6 hours post vaccine. patient unable to report to work the following day, symptoms then resolved.
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| 60 | 2021-01-14 | decreased appetite |
Patient reports chills, fever, muscle aches, headache, 100.1 within 24 hours. Also report loss of ap...
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Patient reports chills, fever, muscle aches, headache, 100.1 within 24 hours. Also report loss of appetite, fatigue.
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| 60 | 2021-01-14 | nausea |
Chills; nausea; headache; This is a spontaneous report from a contactable consumer (patient). A 60-...
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Chills; nausea; headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old adult female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3246), via an unspecified route of administration on 08Jan2021 11:45 AM at single dose on the right arm for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior vaccination. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown), on 18Dec2020 12:00 PM on right arm. COVID-19 vaccine was administered in the hospital. The patient experienced chills, nausea and headache on 09Jan2021 01:30 AM. No treatment received for the events. The events were assessed as non-serious. Outcome of the events was recovered in Jan2021. The patient has not been tested for COVID-19 since the vaccination.
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| 60 | 2021-01-14 | nausea |
Employee reported chills, muscle aches, headache, pain at injection site, fatigue, nausea, pruritus,...
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Employee reported chills, muscle aches, headache, pain at injection site, fatigue, nausea, pruritus, and pressure on her upper back. She reported feeling anxious when she laid down. She went to see her doctor last week and was treated with benadryl.
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| 60 | 2021-01-17 | abdominal pain upper |
limping one side of foot; wanted to pass out; numbness to right side of face; every muscle in her bo...
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limping one side of foot; wanted to pass out; numbness to right side of face; every muscle in her body hurts; stomach is cramping; This is a spontaneous report from a contactable consumer. A 60-years-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140) , via an unspecified route of administration on 04Jan2021 at the first single dose at Arm Left for covid-19 immunisation . Medical history reported as none. There were no concomitant medications. The patient experienced wanted to pass out, numbness to right side of face, every muscle in her body hurts, stomach is cramping on 08Jan2021, limping one side of foot on 11Jan2021. The outcome of event wanted to pass out was unknown; outcome of event numbness to right side of face, stomach is cramping, limping one side of foot was not recovered; outcome of event every muscle in her body hurts was recovering;
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| 60 | 2021-01-18 | abdominal pain, vomiting, decreased appetite, appendicitis, nausea |
Lot number for the first dose was EK5730. After receiving the 2nd dose on the 01/11/2021 went to lun...
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Lot number for the first dose was EK5730. After receiving the 2nd dose on the 01/11/2021 went to lunch and in the evening started feeling nausea and was throwing and abdominal pain. Went to work sick Tuesday and Wednesday low grade fever, nausea and abdominal pain, wasn't eating was to sick to eat. Thursday early morning hours the pain was unbearable so she went to the ER and the cat scan. It was determined that she had appendicitis and they removed my appendix same day. Feels so much better now.
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| 60 | 2021-01-18 | nausea |
fever (100,4, 101 and 100); I was a little ache like a flu; I was a little ache like a flu; Felt rea...
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fever (100,4, 101 and 100); I was a little ache like a flu; I was a little ache like a flu; Felt really hot in my face; I just kind of felt little nauseous; Little bit of chills; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient medical history included ongoing hypertension. Concomitant medication included amlodipine besilate at 5 mg once a day for hypertension, acetylsalicylic acid (BABY ASPIRIN) at 81 mg once a day, vitamins and metoprolol succinate at 50 mg twice a day for hypertension. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. On Jan2021, the patient reported that: " I was running a fever like above 100.4, I was a little ache like a flu" and " I woke up and I just felt really hot in my face, I just kind of felt little nauseous and a little bit of chills and I took my temperature and it was like a 100, so I went to work and I did take a TYLENOL, 2 extra strength TYLENOL around 9:00 and I felt much better and now I am feeling like a fever is coming back so I took my temperature and I was getting like chills again and I took my temperature and it is 101". The patient outcome of the events was unknown.
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| 60 | 2021-01-18 | nausea |
WHEN I GOT TO WORK I DIDN'T FEEL AT MYSELF. I WAS DIZZY AND VERY SHAKEY AND DIDN'T FEEL RIGHT THE M...
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WHEN I GOT TO WORK I DIDN'T FEEL AT MYSELF. I WAS DIZZY AND VERY SHAKEY AND DIDN'T FEEL RIGHT THE MAIN PROBLEM IS IF I CLOSE MY EYES AND GET REALLY DIZZY AND GET SICK AT MY STOMACH
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| 60 | 2021-01-18 | vomiting, diarrhea |
Feeling sick/Not feeling well; Exhaustion; Dizziness; Shakiness; Sore throat; Sleeping nonstop; Head...
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Feeling sick/Not feeling well; Exhaustion; Dizziness; Shakiness; Sore throat; Sleeping nonstop; Headache; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (batch/lot number: EK5730), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient worked at a hospital doctor's office. On 22Dec2020, the next day of vaccination, patient immediately for two days had "immense" (not clarified) headache and then had two days of vomiting and diarrhea. And she had been sick "ever felt" (not clarified) on an unspecified date. She had extreme exhaustion. She had been tested for everything from "manual" to mild "disease" (not clarified). She had extreme exhaustion, dizziness, shakiness, sore throat and Monday would be three weeks that she had been feeling like this. She had never been sick like that she felt like this way. She was supposed to get the second vaccine the day after the time of the report yeah so any way. They wouldn't give her because she was not feeling well but she wished just going to hold off and might be try it all over again in couple of weeks when she felt better but she really felt not well since had gotten this vaccine. She had never felt like this before in her life had ever felt this way all ever. She had taken an over the counter medication cold and flu medication (further clarified CareOne (batch/lot number: OCE2948, expiry date: Nov2021)), and ibuprofen (ADVIL, batch/lot number: R85569, expiry date: Mar2023) and she had been doing lot of sleeping. She had been sleeping nonstop. The patient underwent lab tests and procedures which included EKG and all kind of blood work with unknown results. Outcome of the events was unknown. Causality was reported as yes by the consumer.
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| 60 | 2021-01-19 | difficulty swallowing, decreased appetite |
Within 5 minutes of getting injected, felt heat over entire body, from top of head to toes, heart ra...
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Within 5 minutes of getting injected, felt heat over entire body, from top of head to toes, heart rate increased. Nurses came over and took VS. BP 180/100, P128, Throat scratchy and hard to swallow. Monitored continuously and had epinephrine ready but didn't inject as about 10 minutes later symptoms started to subside. Stayed in hospital for longer period (unsure of exact time) and then went home. Over the next 2 days, felt listless, weak and no appetite.
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| 60 | 2021-01-19 | nausea, difficulty swallowing |
Dizziness, Nausea, clammy, shaky, trouble swallowing, throat closing, pulse racing . Treated at WS ...
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Dizziness, Nausea, clammy, shaky, trouble swallowing, throat closing, pulse racing . Treated at WS GSH ED Was given Benadryl, Prednisone and Pepcid orally Was discharged after 4 hours
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| 60 | 2021-01-20 | decreased appetite |
1. Fever lasting 30 hours. It began approximately 11 hours after my shot, and ended 30 hours later....
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1. Fever lasting 30 hours. It began approximately 11 hours after my shot, and ended 30 hours later. Fever ran about 102 degrees most of the time. 2. Chills 3. Loss of appetite and body aches lasting approximately 3 days 4. Hives in armpits, worse on the side of the injection. I noticed it 48 hours after the injection, and I still have them 1 week later. They are much better, but still visible and itchy. 5. Sensitive and painful gums
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| 60 | 2021-01-20 | nausea |
taking new meds for allergic; red spots on roof of mouth; bumps on roof of mouth; rash around the co...
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taking new meds for allergic; red spots on roof of mouth; bumps on roof of mouth; rash around the corners of my mouth; sore arm; nausea; headache; This is a spontaneous report from a contactable consumer. This consumer reported for that the 60-year-old female patient who received first dose of bnt162b2 (Pfizer Pfizerbiontech covide-19 Vaccine EUA), via an unspecified route of administration on 03Jan2021 10:00 AM on Left arm at single dose for covid-19 immunisation. She is not pregnant. Medical history included Known allergies: Penicillin sulfa. No other vaccine in four weeks. Concomitant medications included in two weeks: escitalopram oxalate (LEXAPRO), valaciclovir hydrochloride (VALTREX). The patient experienced Day 1 sore arm, nausea, headache from 05Jan2021 12:00AM, Day 2 nausea from 06Jan2021, Day 3 rash around the corners of my mouth from 07Jan2021, Day 4 bumps on roof of mouth from 08Jan2021, Day 5 red spots on roof of mouth from 09Jan2021, Day 6 Continued red spots went to Doctor, Day 7 taking new meds for allergic reaction from 11Jan2021, Day 8 headache mouth improving. AE resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering. Treatment was received included Doxycycline. No covid prior vaccination. No covid tested post vaccination. No follow-up attempts are possible; information about batch/lot number cannot be obtained.
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| 60 | 2021-01-20 | vomiting, diarrhea | Sore arm vomiting diarrhea muscle pain pain in the neck to the shoulders |
| 60 | 2021-01-23 | nausea | developed muscle tremors, ataxia, unable to walk, nausea |
| 60 | 2021-01-24 | abdominal discomfort |
12 hours after injection uncontrollable shaking with chills, severe headache and body aches. Hours l...
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12 hours after injection uncontrollable shaking with chills, severe headache and body aches. Hours later turned into sweating/heat. Mild upset stomach throughout. Soreness/brusing at injection site. After 18 hours headache persisted with mild body aches and upset stomach. Still soreness /brusing at injection site. 24 hours after injection very mild backache. No headache. Soreness at injection site. No other issues.
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| 60 | 2021-01-24 | abdominal pain |
Chills (freezing), aches and pain all over, headache, felt feverish with no fever, painful arm at s...
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Chills (freezing), aches and pain all over, headache, felt feverish with no fever, painful arm at site of injection with swelling- took total of 4 tylenol over a course of 20 hours- symptoms lasted about 20 hours- arm swelling and pain lasted about 3 days
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| 60 | 2021-01-24 | nausea, vomiting |
Awoke in the early morning hours of 1/23/21 with severe vertigo, almost fell over twice while walkin...
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Awoke in the early morning hours of 1/23/21 with severe vertigo, almost fell over twice while walking to the bathroom. Vertigo caused severe nausea and vomiting, with inability to drink or eat for 36 hours. I became dehydrated. Went to the ED and was admitted overnight for vertigo, orthostatic hypotension, dehydration.
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| 60 | 2021-01-24 | nausea, vomiting |
Pain through whole body and tremoring; Pain through whole body and tremoring/ whole body was sore; T...
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Pain through whole body and tremoring; Pain through whole body and tremoring/ whole body was sore; Things started looking funny/ Funny feeling in her ears; Deaf and couldn't hear; Leg cramps in both legs and toes curled out/ muscle spasming; Dizzy; nauseous; Threw up twice; Bruise at injection site; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL3246) via an unspecified route of administration on the arm left on 05Jan2021 around 12:00 PM at single dose for COVID-19 immunization. The patient used to get legs cramps when she was pregnant with her twins, but it was only one leg. The patient stated she delivered six children, was in car accidents, and had surgeries. And the patient stated the pain from the COVID-19 Vaccine was beyond any other pain she has experienced. The patient needed glasses to read patient card. And stated her eyesight was going. The patient was pretty healthy. There were no concomitant medications. The patient had no prior vaccinations within 4 weeks. And the patient did not receive additional vaccines on same date that administered BNT162B2. The patient experienced deaf and couldn't hear on 06Jan2021 09:00, leg cramps in both legs and toes curled out on 05Jan2021 19:00, dizzy on 05Jan2021, nauseous on 05Jan2021, threw up twice on 05Jan2021, things started looking funny on 06Jan2021 09:00, pain through whole body and tremoring on 06Jan2021 10:00, bruise at injection site on Jan2021. All the events (except for event bruise at injection site) were reported as seriousness as life threatening. Clinical course: the patient worked nightshift. Laid down that afternoon to take a nap and got up around 10:00. Around 05Jan2021 19:00 PM had sever leg cramps in both legs where her toes were curled out. Leg cramps after vaccine wouldn't go away and it was in both legs. Just wouldn't go away. Around 05Jan2021 21:00 PM it went away. The patient was dizzy, nauseous, and threw up twice on the night of 05Jan2021, and going into 06Jan2021. The patient went to the couch in the hotel room and started going deaf. She couldn't hear anything on 06Jan2021 around 09: 00 AM. Things started looking funny on 06Jan2021 around 09: 00 AM. Woke up at 09:35. Hour after that there was pain through her whole body and everything was hurting at 10:00 AM on 06Jan2021. The patient was tremoring at 10:00 AM on 06Jan2021. Couldn't reach the phone to dial 9-11. Thought she was going to die. Last until about noon and then started to go away. Doesn't know if it is safe to take the second vaccine. Doesn't know if these are thing that should have happened to her. She started to get real concerned. Went into hotel room and started feeling dizzy again. Stopped haring things. Funny feeling in her ears. Was seeing things, got dizzy, and everything got dark. Everything lasted until 12:00 PM on 06Jan2021. Everything was good now. The patient had a bruise where injection was in Jan2021. Stated it was nothing compared to what she went through. Woke up around 10:00 AM. Then went back to sleep and got up around 18:00 PM. She felt fine. Her whole body was sore from the muscle spasming. The outcome of the event bruise at injection site was unknown, of the event leg cramps in both legs and toes curled out was recovered around 05Jan2021 21:00, the outcome of other remain events was recovered on 06Jan2021 12:00. The reporter considered (method of assessment: Global Introspection) that all the events were related to BNT162B2.; Sender's Comments: All the reported events were possibly related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship. However, it is worth noting that the 60-year-old female patient had car accidents history and had surgeries. All the events started when she worked nightshift, including leg cramps in both legs and toes curled out, nauseous, threw up twice, pain through whole body, tremoring and transient deafness. Patient did not get rest after vaccination may a risk factor to the onset of the events. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 60 | 2021-01-24 | nausea |
Temperature 101.7; Back pain/pain in her back; Right upper jaw pain that felt like sinus; Heart rate...
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Temperature 101.7; Back pain/pain in her back; Right upper jaw pain that felt like sinus; Heart rate 130's; Oxygen Saturation dropping; Headache/head felt like it would explode; Ringing in the ears; Thighs are burning; calf pain/Calves were sore in back; Calves were sore in back and felt like DVT; Chest pressure; she sound like a hypochondriac; flu like symptoms; can barely walk; Nausea; Shivering; weak; felt miserable; dry hives; This is a spontaneous report from a contactable Nurse reporting for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EL1283, Expiry Date: 30Nov2021, intramuscularly into right deltoid on 11Jan2021 07:15 at single dose at the hospital for Precaution as frontline healthcare worker. Medical history included Wolff-Parkinson-White (WPW) syndrome from 2000, heart surgery in the past on unknown date, had surgery that was in 2000. Years of chest pain and PVC after that; allergic to Sulfa with hives: One time she mixed it up with a medication of her sons and took it by mistake and did not realize it and she did not have any reaction, she has not had in years. It was an injection and she doesn't have the name, lot or expiration. Family medical history included Mother was diabetic and sister was prediabetic and was 61. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (Lot E49899) on 18Dec2020 at 10:30 am injected in Right Deltoid for COVID-19 immunisation and experienced shivering; same body aches, she took TYLENOL; had major headache all night long, all over her head; It was a pressure headache; Someone gave her MOTRIN and within 3 hours she was totally fine. The patient stated she received the Pfizer COVID vaccine second dose on 11Jan2021 and has had problems since then. She has been miserable, took paracetamol (TYLENOL), headache, have ringing the ears, head was exploding, back aches, calf pain, temperature at 8 am 101.7 and 101.7 at 10:40 on 12Jan2021, feeling very weak, nausea, dry hives, Right upper jaw pain that felt like sinus, all in Jan2021. Her heart rate was in the 130's at 3:30-4:00 on 12Jan2021 and now down to 115-108. Her Oxygen saturation has been 91-95 %. She just had a miserable night (Jan2021). She had this pressure in her chest. Her heart rate was 130 and O2 was 93%. Her O2 saturation last night (on 11Jan2021) was 91-94%, mostly about 93%. Chest Pressure began around 3am on 12Jan2021. She called healthcare provider and was waiting to get advice from them if she needs an EKG. She was still having a little bit of mild pressure. She noticed that her oxygenation was 93% when this was happening. It went up to 95% for a second last night. Her heart rate was now between 112-115. When she walked, it went to 125-130. It started around 3:30-4:00 this morning (on 12Jan2021) and was mildly improved. she was feeling the chest pressure back pain had lesson, but had pain in the upper jaw, flu like symptoms on 12Jan2021. she said she could not get out of the bed right. She did have a heart surgery in the past, her legs were burring, and week. she said after the first dose she did had a reaction but took MOTRIN and went to work the next day. The patient wanted to know about the heart rate being high and ringing in the ears. She wanted to know if it was supposed to drop your saturation and increase your heart rate. Is she just behaving like the norm or should her O2 be much higher. Her first shot was not as bad as this reaction. There was no prescriber. The temperature just began now as she just took it. Oxygen Saturation dropping began when she woke up in middle of night around 3:30- 4:00. She used her pulse oximeter and noticed it then. It was associated with her ears ringing and her head felt like it would explode at 3:30 on 12Jan2021. She felt better with headache but still had it. She was so weak on 12Jan2021, she did not want to go anywhere. Her oxygenation had worsened to 93% on average. She had a headache last time but did not have ringing in her ears. She woke up about 3:30 with it. The headache now was all over head from front to back and comes and goes. Last time she went to work after receiving the first one and today (on 12Jan2021), there was no way she could go to work. She took TYLENOL when she got home because she was shivering and took more at 3:30 because she felt miserable because of her chest. She took 1 gram. Her headache did not go away. She got to sleep after she took the TYLENOL. Her back and jaw was bothering her. It felt like the flu. She had upper jaw pain and pain in her back. She didn't have a good back and just aches. After the first one, it took 10 hours for the shivering to start. This time it was very similar. The shivering started about 10 hours later, at 9pm on 11Jan2021. Back pain starting at 05:00 on 12Jan2021 was stated as being sharp on right side scapula and feel like the flu. It is to the right of spinal vertebrae. She thought she would go to bed and lie down. She has had back pain before. The jaw pain started around 05:00 on 12Jan2021. She felt it in her cheek. It was a little bit better. Nausea started at 11:00 pm on 11Jan2021 and got worse at 03:30 when she got up to go to the bathroom around midnight. She felt like she could vomit and felt better, but she couldn't. Her thighs were burning at 03:30 on 12Jan2020. It was persistent weak and burning. She can barely walk. The areas that have hurt like when you get the flu, she was having now in the same places, so she thought it was from the shot. Calves were sore in back and felt like a DVT (Deep vein thrombosis), started at 03:30 of 12Jan2021 and was still sore. She said she sound like a hypochondriac. It was in back of calf towards knee. She did not think it was a blood clot. It was feeling better. It was still sore but nothing like it was at 03:30. It is just an odd pain. She did not want to leave the house and surprised that her oxygen saturation was low. She just wanted to go back to sleep for a bit. Oxygen Saturation dropping was reported as worsened. The outcome of events Chest pressure, Heart rate 130's, Headache/head felt like it would explode, Right upper jaw pain that felt like sinus, calf pain/Calves were sore in back and Calves were sore in back and felt like DVT was recovering. The outcome of events Oxygen Saturation dropping, Ringing in the ears, Shivering, Back pain/pain in her back, Nausea, and Thighs are burning was not recovered. The outcome of events Temperature 101.7, she sound like a hypochondriac, dry hives, flu like symptoms, weak, felt miserable and can barely walk was unknown. The reporter considered events Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Right upper jaw pain that felt like sinus and Thighs are burning were related to BNT162B2. The reporter considered events Chest pressure, Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Headache, Ringing in ears, Shivering, Back pain, Nausea, Thighs are burning, Right upper jaw pain that felt like sinus and Calves were sore in back and felt like DVT as serious due to Medically significant.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 60 | 2021-01-25 | nausea |
Fever 100.7; dizziness; fatigue; labile hypertension; confusion; forgetfulness; difficulty concentra...
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Fever 100.7; dizziness; fatigue; labile hypertension; confusion; forgetfulness; difficulty concentrating; nausea; severe headaches; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ElL0142), via an unspecified route of administration in left deltoid on 03Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included wheat allergy, celiac disease, and hypotension from an unknown date and unknown if ongoing. Concomitant medication included buspirone, cefixime (FLEXERIL), paracetamol (TYLENOL) and esomeprazole. On 05Jan2021 09:00 PM, the patient experienced fever 100.7, dizziness, fatigue, labile hypertension, confusion/forgetfulness, difficulty concentrating, nausea and severe headaches. No treatment was given to the patient for the events. The outcome of the events was not recovered. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19, PCR and Nasal swab both negative on 06Jan2021.
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| 60 | 2021-01-26 | decreased appetite |
26th 0130-can't move, all joints bones-Can't get out of bed. No eating. Poor voiced quality. She's...
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26th 0130-can't move, all joints bones-Can't get out of bed. No eating. Poor voiced quality. She's been vomiting. When I asked her the Lot# and manufacturer-she said-stop yelling- don't get frustrated-began to cry-I softy asked the question again Lot# and Manufacturer. Told to go see her PCM.
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| 60 | 2021-01-26 | nausea, diarrhea |
C/o muscle aches, calf cramps, (B) feet numbness, cough, nausea, diarrhea, all began after #2 vaccin...
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C/o muscle aches, calf cramps, (B) feet numbness, cough, nausea, diarrhea, all began after #2 vaccine. No problems with #1 vaccine Tx antiemetic, H2 blocker, anti histamine, Tylenol push fluids
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| 60 | 2021-01-26 | nausea | Nausea |
| 60 | 2021-01-26 | nausea |
Fatigue but only in evening. Able to work. Irregular heart beat (not normal intermittent PVC) that c...
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Fatigue but only in evening. Able to work. Irregular heart beat (not normal intermittent PVC) that caused chest discomfort. Nothing concerning, just more curious. With second vaccine, developed chills within one hour and went to bed. Upon awakening, had headache, nausea, chills, kidney area pain, chest discomfort from irregular heart beat. This resolved for about 18 hours, then started again and lasted for 1 week. Chest pain became sharp at times spreading to arm with mild shortness of breath. Having had a full heart workup last year, did not pursue tests. wanted to see if would pass on it's own. After one week, only have occasional chest discomfort. Arrhythmia has returned to baseline occasional PVC. No further chills, headache, nausea or other pains.
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| 60 | 2021-01-26 | nausea |
weird taste in mouth; like a burnt oatmeal taste; Nausea; This is a spontaneous report from a contac...
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weird taste in mouth; like a burnt oatmeal taste; Nausea; This is a spontaneous report from a contactable nurse. A 60-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL1283, expiry date not reported), intramuscular on 09Jan2021 12:00 at a single dose in the left arm for COVID-19 immunization. Medical history included had known allergies to sulfa and patient had the COVID virus back in Oct2020 to an unknown date. The patient was not pregnant at the time of vaccination. Concomitant medication included celecoxib (CELEBREX). The patient had the first dose of BNT162B2 on an unknown date for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in the hospital. Patient wanted to report a side effect and was reading a little about it. She had her second dose of the Pfizer Covid-19 vaccine last Saturday, 09Jan2021 and has like a weird taste in her mouth on 11Jan2021. It's like a burnt oatmeal taste. Patient wanted to know if anyone has ever reported that. Patient reported nausea with weird taste in my mouth, not a loss of taste but taste of burnt oatmeal. Patient had the COVID virus back in Oct2020 and she didn't have taste or smell at all then and now she has a taste so it's not like she has COVID again. No treatments received in related to the events reported. Since the vaccination, the patient has not been tested for COVID19. The outcome of the events "weird taste in mouth; like a burnt oatmeal taste" and nausea was not recovered. Information on the batch/lot has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021025273 Pfizer
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| 60 | 2021-01-27 | abdominal pain |
arm pain; light headedness; abdominal pain; swollen, tender lymph node left axillary area; swollen, ...
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arm pain; light headedness; abdominal pain; swollen, tender lymph node left axillary area; swollen, tender lymph node left axillary area; This is a spontaneous report from a contactable nurse (patient). A 60-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EK4176; expiration date: unknown), via an unspecified route of administration left arm on 08Jan2021 08:30 at a single dose for covid-19 immunization. The patient medical history was not reported. The patient has no known allergies. There were no concomitant medications. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EK5730; expiration date: unknown), via an unspecified route of administration left arm on 18Dec2020 10:30 at a single dose for covid-19 immunization. The patient experienced arm pain, light headedness, abdominal pain and swollen, tender lymph node left axillary area on 08Jan2021 04:00 PM. The patient received treatment for the adverse events includes acetaminophen (TYLENOL) and ibuprofen (MOTRIN). The outcome of the events was recovered on in Jan2021.
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| 60 | 2021-01-27 | nausea |
Muscle pain; Chills; Nausea; This is a spontaneous report from a contactable consumer. A 60-year-old...
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Muscle pain; Chills; Nausea; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in left upper arm on 11Jan2021 around 3:45-4:00pm at a single dose for COVID-19 vaccination. Medical history included hypothyroidism. Concomitant medication included levothyroxine from 2006 for hypothyroidism. The patient was administered the first dose of Pfizer-BioNTech COVID Vaccine on 11Jan2021 at work. On 12Jan2021, the patient experienced muscle pain, chills, nausea. The outcome of the events was not recovered. The patient underwent rapid COVID-19 nasal swab test and the result was negative on 12Jan2021. Second dose scheduled to be administered on 01Feb2021 with no dose change made. Information on the Lot/batch number has been requested.
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| 60 | 2021-01-28 | diarrhea |
day 5 vertigo just morning dizziness all day better the next day. very tired no energy feeling cru...
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day 5 vertigo just morning dizziness all day better the next day. very tired no energy feeling crummy, migraines by day 6, 7 and 8... worst than normal and lasting longer than normal. usually get relief after 1 dose but it would take at least 2 before feeling somewhat better. some diarrhea, body aches. pain in my left arm and side around lung area. had chest x-ray on 1-11-21 clear. this all lasted until 1-27 or 1-28 felling a lot better today 1-29-21.... these are all the symptoms i had when i had covid in Nov. it was like having it all over again......
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| 60 | 2021-01-28 | nausea, abdominal pain |
Moderate Swelling and pain under right axilla Redness swelling at site Nausea Aches Abdominal pain ...
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Moderate Swelling and pain under right axilla Redness swelling at site Nausea Aches Abdominal pain Headache
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| 60 | 2021-01-28 | nausea |
Headache; chills; shaking; weakness; tiredness; nausea; Joint pain; muscle pain; This is a spontaneo...
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Headache; chills; shaking; weakness; tiredness; nausea; Joint pain; muscle pain; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 15Jan2021 at 13:15 (at the age of 60-years-old) at a single dose for COVID-19 immunization. Medical history included arthritis (knees), sulfa drugs allergy, poison ivy allergy (severe), and COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included meloxicam (MANUFACTURER UNKNOWN) and furosemide (LASIX). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced headache, chills, shaking, weakness, tiredness, nausea, joint pain, and muscle pain on 16Jan2021 at 13:00. The events were reported as non-serious. The patient underwent lab tests and procedures which included COVID-19 nasal swab: negative (test name: Binex) on 12Jan2021 and COVID-19 test: unknown results (post vaccination) on an unspecified date. Therapeutic measures were taken as a result of the events, which included naproxen sodium (ALEVE); it was reported that the treatment did not work. The clinical outcome of headache, chills, shaking, weakness, tiredness, nausea, joint pain, and muscle pain was unknown. The batch/lot number for the vaccine, BNT162B2, was provided and has been requested during follow up.
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| 60 | 2021-01-31 | nausea |
nose bleed/kind of "blew like a quarter size of blood clot"; congestion in her throat; headache; tir...
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nose bleed/kind of "blew like a quarter size of blood clot"; congestion in her throat; headache; tired, very tired and just wanted to sleep; nausea, some nausea; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0140 and expiry date unknown) via unspecified route of administration on 14Jan2021 at single dose for Covid-19 immunization on her job (nursing home). Medical history included blood pressure high. Concomitant medications vitamins. The patient took that COVID-19 vaccine shot yesterday (later clarified the date as 14Jan2021) on her job. The patient informed that she was okay the first day, but yesterday (15Jan2021) last night she had some new problems and she wanted to talk about and see it's a clinical sign. The patient informed that it was headache, tired, very tired and just wanted to sleep. The patient had no swelling/no swelling in arm, nausea, some nausea and even she has been just feeling unwell. The patient informed that today (16Jan2021) this morning, she was having nosebleed until the last time she felt like congestion in her throat and she kind of "blew like a quarter size of blood clot". The patient blew her nose and it bled a while, but then a quarter size blood clot come out and since then it wasn't bleeding, her nose was not bleeding. The patient did not receive treatment due to the events. The patient underwent lab tests and procedures which included COVID testing; swab the nose: negative on 13th or maybe 14th (Jan2021). The outcome of the events headache, tired, very tired and just wanted to sleep, nausea, some nausea, feeling unwell, nose bleed/kind of "blew like a quarter size of blood clot", congestion in her throat was unknown.
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| 60 | 2021-01-31 | vomiting, nausea |
6 hours after vaccination: vaccination sight soreness and swelling - still have this symptom 3 days...
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6 hours after vaccination: vaccination sight soreness and swelling - still have this symptom 3 days later 12 hrs after vaccination: Nausea, vomiting, headache, body aches, fever (100.7 at peak), chills. Lasted approximately 36 hours. 48 hours after vaccination: vaccinated arm has tingling sensation and weakness when raised, armpit lymph nodes tendor/sore - still have this symptom 3 days later. Took Aleve to alleviate symptoms. It lessened them somewhat but I was still not able to function fully for several days.
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| 60 | 2021-02-01 | diarrhea |
Late (11 pm ish) on 1/24/21 severe diarrhea started, lasted through early (8 am ish) on 1/26/21. On ...
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Late (11 pm ish) on 1/24/21 severe diarrhea started, lasted through early (8 am ish) on 1/26/21. On 1/25/21 I also had fever (highest was 101.4), chills, weakness, and aching bones. I also had a terrible headache that started 1/20 and lasted until 1/ 28 or 1/29. There was the normal injection site soreness on the evening of the first day.
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| 60 | 2021-02-01 | diarrhea |
Fatigue; headache; earache; sore throat; fever of 101.4 for 24 hours; Diarrhea; Could do nothing but...
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Fatigue; headache; earache; sore throat; fever of 101.4 for 24 hours; Diarrhea; Could do nothing but sleep; administration date=15Jan2021 (dose number: 2); administration date=23Dec2020 (dose number=1); This is a spontaneous report from a contactable other health professional (patient). A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), via an unspecified route of administration on 15Jan2021 at 13:30 at a single dose in the left arm for COVID-19 immunization. The patient's medical history included allergies when younger, known allergies to wheat, dairy, cats, and mold. There were no concomitant medications. The patient previously took levofloxacin (LEVAQUIN) and nitrous oxide and experienced allergies; also had her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231) on 23Dec2020 at 11:30 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 15Jan2021, the patient experienced fatigue, headache, earache, sore throat, and fever of 101.4 for 24 hours, and diarrhea. The patient could do nothing but sleep. The patient did not receive any treatment for the reported events. The patient was not pregnant at the time of vaccination. The outcome of the events was recovering.
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| 60 | 2021-02-01 | nausea |
Received vaccine #1 Phizer on Jan 5th 2pm. Started to feel tired by 7pm. 5am woke up achey with gene...
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Received vaccine #1 Phizer on Jan 5th 2pm. Started to feel tired by 7pm. 5am woke up achey with general malaise. Took Tylenol 500mg and came to work. I started the attestation form and called employee health to let them know about my aches. They recommended me getting tested for Covid 19 in which I did before I left at 8:30am. My health continued to decline as I became ferverish, with a headache, nauseas, foggy, and exhausted. When I got home, I couldn't get off the couch. I felt horrible for 36hrs. My headache lasted for 5 days. Covid 19 test and flu test negative.
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| 60 | 2021-02-01 | nausea |
Dizziness and nausea within 7 minutes of receiving vaccine. 6 Hours after vaccine severe arm pain, s...
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Dizziness and nausea within 7 minutes of receiving vaccine. 6 Hours after vaccine severe arm pain, sensitive to touch, movement and unable to lift arm beyond 45 degree angle. 17 hours after vaccine chills, fever of 102, muscle aches, severe headache, fatigue. 53 hours after vaccine, fever 101, severe headache, muscle aches, fatigue. Arm pain much less severe.
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| 60 | 2021-02-02 | nausea, abdominal discomfort |
Was okay Friday morning then stomach started getting upset Friday night and I tried to eat food to c...
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Was okay Friday morning then stomach started getting upset Friday night and I tried to eat food to calm down. A slight headache was starting. The next morning I had a massive headache all day Saturday, by 8 PM it was a full-fledged nauseating migraine. The severe migraine lasted from 8 PM the previous night to 10 PM on Sunday night. By Monday I was doing better but a bit confused and having difficulty thinking. Now it is Wednesday and I am a bit exhausted and still having trouble thinking but doing so so much better! I am so happy to be feeling better!
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| 60 | 2021-02-02 | nausea | Pt reports feeling "out of body", lightheaded, impending doom, nauseated and diaphoretic. |
| 60 | 2021-02-02 | vomiting | Severe vertigo: onset 1 hour after injection followed by vomiting x3- Benedryl taken |
| 60 | 2021-02-03 | nausea |
nausea and dizziness/dizziness and nausea went pretty extreme; nausea and dizziness/dizziness and na...
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nausea and dizziness/dizziness and nausea went pretty extreme; nausea and dizziness/dizziness and nausea went pretty extreme; This is a spontaneous report from a contactable consumer (husband of patient). A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number, expiration date unspecified), via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 13Jan2021, 2 days after vaccination, patient experienced nausea and dizziness, that went away. Until yesterday, 19Jan2021, her dizziness and nausea went pretty extreme. She was scheduled for a second dose in about 2 weeks, on 09Feb2021. Outcome of events was not recovered. Information on the lot/batch number has been requested.
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| 60 | 2021-02-03 | nausea |
11pm evening of shot woke with body aches. Approx. 2am woke again with extreme chills, headache & na...
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11pm evening of shot woke with body aches. Approx. 2am woke again with extreme chills, headache & nausea. Somewhat lethargic throughout the day but no symtoms other than slight headache. Woke the next morning at 3am with extreme chills again. Seem to feel ok but not 100% today.
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| 60 | 2021-02-03 | nausea |
Starting about 30 minutes after the injection she had nausea and occasional dizziness. About 12 hour...
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Starting about 30 minutes after the injection she had nausea and occasional dizziness. About 12 hours later she began having fever, chills and muscle aches. Fever improved with Motrin.
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| 60 | 2021-02-04 | diarrhea, vomiting |
After less then 48 hours I woke up with diarrhea. Then I started throwing up followed by severe chil...
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After less then 48 hours I woke up with diarrhea. Then I started throwing up followed by severe chills & body aches, a fever & a headache
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| 60 | 2021-02-04 | nausea | 6 hours after shot became extremely dizzy and nauseous. |
| 60 | 2021-02-06 | vomiting, abdominal pain upper |
High heart rate. Vomiting, extreme fatigue. My body feels like is vibrating on the inside & shaking ...
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High heart rate. Vomiting, extreme fatigue. My body feels like is vibrating on the inside & shaking on the outside. Headache & extreme stomach pain. Which all of this has made it to where I'm unable to work.
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| 60 | 2021-02-07 | nausea |
Started to feel achy, then it got worse; very painful. Some nausea, chills, headache, lethargic. Mos...
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Started to feel achy, then it got worse; very painful. Some nausea, chills, headache, lethargic. Most symptoms gone in 20 hrs. After that a few days feeling sluggish.
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| 60 | 2021-02-07 | nausea |
Nausea; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female pat...
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Nausea; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: En5318; Expiration date was not reported) on 22Jan2021 (10:45) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization. Medical history included multiple (MS), blood clots and pulmonary embolism. Concomitant medications included rivaroxaban (XARELTO) and omeprazole. The patient previously took clarithromycin (BIAXIN), and had drug allergies. The patient was not pregnant at the time of vaccination. On 23Jan2021 (16:00), the patient had nausea. The patient did not receive any treatment for the event, nausea. The outcome of the event, nausea, was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested post-vaccination.
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| 60 | 2021-02-07 | nausea | Fever 100.2F; chills, nauseous, weakness |
| 60 | 2021-02-09 | abdominal pain upper, abdominal discomfort, abdominal pain upper, abdominal discomfort | Next day bad headache, two days later bad GI upset, stomach pain inflammation ; 2nd vaccine Psfizer |
| 60 | 2021-02-09 | diarrhea |
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous re...
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positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer reported for herself. A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot# EL3249, exp.date May2021 on 15Jan2021 16:00 at single dose for COVID-19 immunization, via unspecified route of administration at the left arm. The patient had get earlier in January a DPT (diphtheria, pertussis, and tetanus) vaccine in the left arm. The patient had have a Pneumonia and Shingles vaccines in the last 2 years and she had no problems in past with vaccines, but stated she did get a little bit of swelling and had to put heat to the area with vaccines, but never had a fever afterwards. The patient had not medical history. Concomitant medications were not reported. No other vaccines given the same day. Since 16Jan2021, he started having symptoms, fever, cough and Diarrhea. On 17Jan2021 the patient was positive to SARS-CoV-2 test. On 19Jan2021 she received monoclonal antibody therapy. The outcome of the event was not recovered.
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| 60 | 2021-02-10 | nausea, diarrhea |
Could not raise my arm the next morning with out extreme pain from the site to the arm pit to the ne...
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Could not raise my arm the next morning with out extreme pain from the site to the arm pit to the neck. Then my arm pit was swollen, hot and the swelling went down my arm. I also had diarrhea, Nausea, slight head ache, chills, body ache with a temp of 101.5. Went to the doctor yesterday because of my armpit swelling, hot to touch and it had a red band. She said where they gave it was not in a muscle. It was given sub Q & that it went into my lymph gland and leaked down my arm to swell. Right now I just have on and off nausea , pain in my lymph glands in my arm pit. The swelling and pain has gone down and the other symptoms have faded away.
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| 60 | 2021-02-14 | diarrhea | Intermittent cramping and diahrrea from midnight Sunday through Monday 2/15 (so far) |
| 60 | 2021-02-14 | diarrhea |
Soreness at site of injection; loose bowels; This is a spontaneous report from a contactable consume...
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Soreness at site of injection; loose bowels; This is a spontaneous report from a contactable consumer (patient herself). This consumer reported for 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247) via unspecified route of administration on 26Jan2021 at 02:30 PM in left arm at single dose for COVID-19 immunization in the workplace clinic. There was no other vaccine administered in four weeks. Medical history included gluten intolerant. No Known allergies. Concomitant medication included calcium, ergocalciferol (VIT D), ibuprofen (ADVIL), multivitamin. The patient was not pregnant at the time of vaccination. The patient did not have COVID prior to vaccination. The patient experienced soreness at site of injection and loose bowels on 27Jan2021 at 07:15 AM. No treatment was received for adverse effects. The patient was not tested for COVID post vaccination. The outcome of events was not recovered. No follow-up attempts possible. No further information expected.
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| 60 | 2021-02-14 | nausea |
2MIN AFTER DOSE DIZZY, VERY CONFUSED, SLIGHT CHEST PRESSURE, 30 MIN LATER SLIGHT SWELLING OVER EYE...
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2MIN AFTER DOSE DIZZY, VERY CONFUSED, SLIGHT CHEST PRESSURE, 30 MIN LATER SLIGHT SWELLING OVER EYELIDS, 1 HR LATER STILL VERY CONFUSED IN A FOG. VERY CONGESTED , SNEEZING, ITCHY EYES, STUFFY EARS, VERY CONFUSED. STRANGE FEELING INSIDE MY BODY - TINGLING . FEELING OUT OF BODY .... NOT MY SELF ...ITCHING. VERY CONFUESED AND VERY DIZZY FOR ABOUT 4 HR... SEVERED HEADACHES. NAUSAUES. 6 HRS LATER SWOLLEN FACE RIGFHT SIDE.
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| 60 | 2021-02-15 | abdominal discomfort, diarrhea |
Day 4 sudden feeling unwell, out of it, severe burning pain throughout whole body, joint pain , head...
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Day 4 sudden feeling unwell, out of it, severe burning pain throughout whole body, joint pain , headache, cough, fatigue, upset stomach, diarrhea. Subsided in about 36 hours.
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| 60 | 2021-02-15 | decreased appetite |
12/19/2020 130 vaccination. When got up to leave, near syncope episode. Monitored for 15+ more minu...
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12/19/2020 130 vaccination. When got up to leave, near syncope episode. Monitored for 15+ more minutes. Left after. Later that evening, I felt like I was on 'speed'. Chills, HA, couldn't sleep. HR was increased. I wasn't able to eat; no appetite. Symptoms lasted for several days. Don't think I ran a fever. I was very dizzy, double vision, extreme fatigue. Did what i could with work online. *HX of aura migraines and happened during this episode. Within that week, saw NP.
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| 60 | 2021-02-15 | nausea, abdominal discomfort |
8:30 pm - extreme shivering, teeth chattering, extremities freezing cold, particularly the feet; sev...
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8:30 pm - extreme shivering, teeth chattering, extremities freezing cold, particularly the feet; severe body aches; injection site throbbing; upset stomach and a feeling of nausea. Temperature 100.2 at 8:45. Took temp every hour. By midnight temp reached 102.7. Head ache started. Couldn?t sleep on my left side because of the extreme pain around the injection site and down my left arm. Finally fell asleep around 2:30 and woke at 5:30. Fever was gone. Temp read 98.9. Body aches still present but not as severe. Arm pain had eased but head ache remained most of the day. Felt much better but just very tired.
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| 60 | 2021-02-16 | nausea, indigestion, abdominal pain upper |
Pfizer-BioNTech COVID-19 Vaccine EUA At 2:30 am woke up with nausea and stomach ache. Continued thr...
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Pfizer-BioNTech COVID-19 Vaccine EUA At 2:30 am woke up with nausea and stomach ache. Continued through the night. I could not sleep. In the morning (9:00) I tried to sleep but had very bad chills for over an hour. Went down to couch and covered up with many blankets. Chills continued for 4-5 hours. Also experienced tiredness, and general 'feeling unwell' throughout the day, as well as extreme heartburn. I stayed home from work and sat on the couch all day, feeling unwell. By about 8pm all of the symptoms disappeared.
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| 60 | 2021-02-16 | nausea |
Extreme fatigue, nausea, chills, headache, dizziness 18-20 hours after receiving the 2nd vaccine for...
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Extreme fatigue, nausea, chills, headache, dizziness 18-20 hours after receiving the 2nd vaccine for about 10-12 hours, then lessening to feeling tired, bouts of vertigo and occasional headache. Five days later on 1/25 I experienced blurry vision, nausea, confusion, dizziness, and impaired speech (to a co-worker). This lasted about an hour.
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| 60 | 2021-02-17 | decreased appetite, nausea |
lightheaded to the point of nearly passing out; nausea; general feeling of being unwell; lightheaded...
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lightheaded to the point of nearly passing out; nausea; general feeling of being unwell; lightheaded to the point of nearly passing out; cold sweat; loss of appetite; pain in upper shoulder/back area; pain in upper shoulder/back area; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL-9265), via an unspecified route of administration on 29Jan2021 12:30 in left arm, at single dose for covid-19 immunization. Medical history included chronic low BP, hypothyroidism, HRT, nasal allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included estradiol, levothyroxine sodium (SYNTHROID), multivitamin NOS (MULTIVITAMIN). The patient previously took amoxicillin; clavulanic acid (AUGMENTIN) and known allergies: Augmentin, being treated for nasal allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea, general feeling of being unwell, lightheaded to the point of nearly passing out; cold sweat, loss of appetite, pain in upper shoulder/back area, on 01Feb2021 06:30. No treatment was received. The outcome of the events was recovering. Since the vaccination, the patient had not been tested for COVID-19.
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| 60 | 2021-02-18 | nausea | Fever, pain in the arm where I got the shot. nauseated |
| 60 | 2021-02-21 | difficulty swallowing |
During 30 minute observation after 1st dose of covid vaccine patient began experiencing palpitations...
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During 30 minute observation after 1st dose of covid vaccine patient began experiencing palpitations/dizziness with BP of 157/99, requested transfer to ED for further evaluation. Began experiencing scratchy sensation to throat, difficulty swallowing with hoarseness of voice 5 minutes after vaccination. Received epinephrine 0.5mg IM once, protonix 40mg IV once, and solu-medrol 125mg IVPB once in ED. Patient was observed in ER for 3 hours and reported having EpiPen and Benadryl at home, was discharged with Prednisone 20mg, 2 tablets daily for 3 days.
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| 60 | 2021-02-23 | nausea |
I only had 1 dose on 2/16/2021 and got the reaction 1 week later 2/23/2021.. Not sure if that's pos...
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I only had 1 dose on 2/16/2021 and got the reaction 1 week later 2/23/2021.. Not sure if that's possible but wanted to report it anyway. body ache, joint discomfort, migraine headache all day, fever, chills & nausea - this started about 10am on 2/23/2021 and lasted until 2am the following morning 2/24/2021. I took 600 mg of motrin every 6 hrs and 600 mg of tylenol every 4 hrs. I feel fine today
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| 60 | 2021-02-25 | abdominal distension, abdominal discomfort |
Eyelids and face swollen, itching on the jaw, tingling sensation and possible stomach upset and some...
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Eyelids and face swollen, itching on the jaw, tingling sensation and possible stomach upset and some shortness of breath.
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| 60 | 2021-02-26 | nausea |
IMMEDIATE Strange warmth/tingling down left arm and then further down body Dizziness Headache Fatig...
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IMMEDIATE Strange warmth/tingling down left arm and then further down body Dizziness Headache Fatigue brief chills LATER & NEXT DAY Pain left arm Muscile aches, especially legs Brief episode of nausea Slight fever
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| 60 | 2021-02-27 | decreased appetite |
slight fever for 2 days, then flu-like symptoms (body aches, fever, chills, lack of appetite, loss o...
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slight fever for 2 days, then flu-like symptoms (body aches, fever, chills, lack of appetite, loss of taste and smell, fatigue) since Wednesday 2/24/21. Missed work due to symptoms on Thursday 2/25/21. Returned to work amidst continuing flu-like symptoms on Friday 2/26/21. As of Sunday, 2/28/21, symptoms continue; maybe slightly diminished.
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| 60 | 2021-02-27 | decreased appetite |
Headache, Low grade fever, cough, loss of appetite, hot flashes, Lost my voice. Didn't feel well Fri...
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Headache, Low grade fever, cough, loss of appetite, hot flashes, Lost my voice. Didn't feel well Friday night, started coughing and feeling unwell. I had a fever in the morning and had lost my voice but wasn't coughing anymore. Today no fever but no voice and I just don't feel well. No appetite today either.
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| 60 | 2021-02-27 | nausea |
At 48 hours After vaccines I developed a headache nauseous Hot the following day I was sore all over...
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At 48 hours After vaccines I developed a headache nauseous Hot the following day I was sore all over still having a headache still nauseous my ribs hurt my hand hurt four days today still not well tired weak headache! So sick ! I do not wish to have the second dose! I really thought I was gonna die
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| 60 | 2021-02-27 | nausea |
That evening starting to feel flu like symptoms. Today I feel like I have the stomach flu-body aches...
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That evening starting to feel flu like symptoms. Today I feel like I have the stomach flu-body aches, headache, sore arm, nausea, 102 fever, joint pain
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| 60 | 2021-02-28 | vomiting, nausea | excessive vomiting, nausea, headache, aches, fatigue |
| 60 | 2021-03-01 | abdominal pain upper |
Left upper abdominal pain after receiving COVID vaccine radiating to left jaw rapid response, had pa...
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Left upper abdominal pain after receiving COVID vaccine radiating to left jaw rapid response, had patient remove mask and reported facial drooping. Transferred to ED for acute, painless, unilateral facial paralysis with no forehead sparing most likely secondary to Bell?s Palsy. Patient was monitored and discharged with prescriptions for valacyclovir 1000mg tid and prednisone 50mg qday x 7 days
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| 60 | 2021-03-01 | nausea, decreased appetite |
At first I didn't feel anything or any different. I started to get a weird sensation behind my eyes ...
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At first I didn't feel anything or any different. I started to get a weird sensation behind my eyes like before with the first vaccine. The muscles of my eyes and eye lids feel weak and difficult to focus. I started having extreme nausea and could not go to work. No appetite either. I now have Oscillopsia and feel sick.
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| 60 | 2021-03-01 | nausea, diarrhea |
I started to get mild nausea within about 15 mins. then a chemical taste in my mouth. Later I ...
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I started to get mild nausea within about 15 mins. then a chemical taste in my mouth. Later I was getting some sputum or phlegm coming up,, no cough, on short of breath no nasal discharge. During the night I woke up because the phlegm was much worse and abundant I wanted to sleep so at first was swallowing it, then it was so much that I got up and went to the bathroom. That is when I noticed that the palms of my hands were scarlet red. on both hands and not on the wrists or any where else. by morning it was gone but I did have diarrhea and still a cold mild nausea feeling in my stomach. Yesterday , 3 days later, still had diarrhea and nausea and was tired,,symptoms are not severe, but since these are not typical symptoms for me. I figured they will go away, but also I figured that I should communicate the reaction . I am scheduled for my 2nd shot in 3 weeks,
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| 60 | 2021-03-02 | decreased appetite |
Elevated blood pressure, headache (2 days), fever, EXTREME chills/shaking, congestion, loss of appet...
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Elevated blood pressure, headache (2 days), fever, EXTREME chills/shaking, congestion, loss of appetite, fatigue, could not lift arm.
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| 60 | 2021-03-02 | difficulty swallowing |
5 minutes after receiving the vaccine, patient became flushed. She also stated that she had a sore t...
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5 minutes after receiving the vaccine, patient became flushed. She also stated that she had a sore throat without SOB or difficulty swallowing. She was able to drink water without difficulty. Her airway was patent and oropharynx was normal on exam. She had no stidor on exam. Patient was advised to seek care at the ED, but she did not.
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| 60 | 2021-03-03 | nausea |
SORE ARM, VERY TIRED, SEVERE HEADACHE, SORE MUSCLES ALL OVER, CHILLS, KNEE AND HIP JOINT PAIN, NAUSE...
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SORE ARM, VERY TIRED, SEVERE HEADACHE, SORE MUSCLES ALL OVER, CHILLS, KNEE AND HIP JOINT PAIN, NAUSEA, SWOLLEN LYMPH NODES UNDER BOTH ARMS, FEELING UNWELL
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| 60 | 2021-03-04 | difficulty swallowing |
Pt in 30 min waiting area. At 10:36 am reported tongue feeling funny. Upon assessment tongue was t...
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Pt in 30 min waiting area. At 10:36 am reported tongue feeling funny. Upon assessment tongue was thick , interfering with speech. BP: 186/93, Heart Rate : 66, Oxygen Saturation 99%, Temperature 97.6 F. Epinephrine 0.3 mL administered on left thigh at 10:42 am and 911 called. Pt reported inability to swallow and chest tightening at 10:51 am. Ambulance arrived.
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| 60 | 2021-03-04 | nausea, vomiting |
COVID Vaccine Adverse Event Documentation After vaccination with COVID Vaccine Dose #1, patient dev...
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COVID Vaccine Adverse Event Documentation After vaccination with COVID Vaccine Dose #1, patient developed evidence of Immediate (within 4 hours of dose) adverse reaction starting 3/5/2021 2:02 PM. Signs/Symptoms: Dry Mouth, Flushing, Lightheadedness, Nausea/Vomiting and Other (see comments) Reaction Comments: Skin blotchiness, dizziness, shaky, responsive but limp Treatment Administered: Cold Compress and Sips of Water Treatment Comments: Crackers, put in supine position Disposition: Home Disposition Comments: Next vaccine should be supine when receiving it. Additional Documentation: Pt became faint immediately after vaccine, warm, shaky and went limp I her chair but was responsive. BP: (!) 150/94 Pulse: 75 Supervising Provider Notified of Reaction: MD
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| 60 | 2021-03-04 | nausea |
4 hours after vaccine, had the following Reaction : -Big Chills -Nausea -Small amount of swelling o...
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4 hours after vaccine, had the following Reaction : -Big Chills -Nausea -Small amount of swelling on Face, Ankles, & Wrists -Very tired = fatigue / sleep
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| 60 | 2021-03-04 | vomiting, diarrhea |
Pt experienced diarrhea at 0300 today with vomiting. Pt had body ache and feeling weak, Temperature ...
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Pt experienced diarrhea at 0300 today with vomiting. Pt had body ache and feeling weak, Temperature was 101 at 0930 this morning. Pt has minimal coughing at this time. Current temperature is 99.9 The pt denies any SOA prior or currently at this time. The pt was informed to eat small amount of crackers as tolerated and fluids as tolerated. Get plenty of rest. Should sx's worsen or SOA occur, then call for an ambulance for assistance.
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| 60 | 2021-03-07 | diarrhea |
I received the shot at 4:30 pm. About an hour after receiving the shot, I felt a little dizzy, and ...
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I received the shot at 4:30 pm. About an hour after receiving the shot, I felt a little dizzy, and my heart started beating faster. My body felt weird. I had a small headache and was very tired and laid down. I fell asleep pretty quickly. I woke up around 2:30 am the following morning, with a greater headache. I took tylenol for the headache. I took another dose of tylenol 4 hours later. I had loose stools, fatigue and my lungs felt heavy (cough) for approx 12 hours. Most symptoms resolved by the following day. A little fatigue and heaviness remains.
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| 60 | 2021-03-07 | difficulty swallowing |
Lip tingling, palpitation, flushing and wheezing/slight SOB within 15-30 mins and sensation that she...
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Lip tingling, palpitation, flushing and wheezing/slight SOB within 15-30 mins and sensation that she was unable to swallow while driving home. Used rescue inhaler when she reached home for relief. Symptoms now resolved. H/O asthma
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| 60 | 2021-03-08 | decreased appetite | fever, chills, back pain, fatigue, loss of appetite, foggy |
| 60 | 2021-03-08 | diarrhea | several bouts of diarrhea after the Pfizer Covid Vaccine (1st One) |
| 60 | 2021-03-08 | difficulty swallowing |
This is a 60-year-old female who just received her second Pfizer dose of the Covid vaccine earlier t...
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This is a 60-year-old female who just received her second Pfizer dose of the Covid vaccine earlier today when she says she felt immediately a flushing of her left arm where she had received the vaccination and then some tingling and abruptly followed with difficulty swallowing tongue enlargement, and feeling like she had to "search for my air". This required her to turn her head leftward to assist in her breathing. She has no associated pruritus. She was given an intramuscular injection of epinephrine at the clinic where she received the vaccination and EMS was activated. She did not demonstrate any changes in her phonation or signs of stridor and there was no wheezing or signs of facial or oral swelling on arrival of paramedics. She received additional intramuscular injection of epinephrine and IV Benadryl and Solu-Medrol at that time followed by an albuterol inhalation treatment and transported here as a medical alert. She reports the symptoms are similar to what she is experienced with multiple bee sting allergic reactions in the past. She is never required intubation. She never develops any facial swelling or urticaria.
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| 60 | 2021-03-08 | difficulty swallowing | throat tightness, elevated HR, difficulty swallowing, chest pressure. Evaluated by EMS-Cleared |
| 60 | 2021-03-09 | difficulty swallowing |
within a couple of minutes after receiving the shot, I felt a sudden flash of warmth throughout my b...
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within a couple of minutes after receiving the shot, I felt a sudden flash of warmth throughout my body. Then my heart started racing. This lasted about a minute. I just sat there since I wasn't sure if this was normal. I started to feel like my heart was going back to normal so I just sat there for the specified 15 minutes. After I left and was driving home, I stated to feel a shortness of breath and difficulty getting air. I also felt like a hard to swallow. I was about 1 mile from venue so this happened with 30 minutes of receiving the shot. This only lasted what seemed like a short time and then I started to feel like I could get my breath. By the time I returned home I was breathing ok but my lips were a little tingly. I felt fine by 5:00 pm.
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| 60 | 2021-03-09 | nausea |
Saturday, March 6 felt fine all day with normal activity. Woke up at 7:05 am Sunday, March 7 with d...
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Saturday, March 6 felt fine all day with normal activity. Woke up at 7:05 am Sunday, March 7 with dizziness, nausea and sweats that would last about a minute. Remained sitting still with my eyes closed about 3 hours and then eyes could be open but could not move without the dizziness and subsequent nausea. I did not vomit. My temperature was-low in the morning but climbed just to 99.3 Sunday. By Sunday afternoon, I no longer had the short sweats but remained dizzy and nauseous mostly upon any movement. I went to sleep at 11:00 pm Sunday night with the slight 99 fever. Woke Monday , March 8 much improved from the dizziness and temperature 98.6., but felt extreme tiredness. I did not go tot work Tuesday and rested on the couch most of the day-temperature 98.6.
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| 60 | 2021-03-09 | nausea |
mild headache, sore arm at injection site, mild nausea, mild weakness. sore arm immediately after in...
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mild headache, sore arm at injection site, mild nausea, mild weakness. sore arm immediately after injection lasting 2 days. Headache, nausea and weakness day after vaccination lasting 24 hours.
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| 60 | 2021-03-10 | diarrhea |
Enlarged lymph nodes following 1st shot-- Diagnostic Mammogram and ultrasound; Severe Diarrhea for ...
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Enlarged lymph nodes following 1st shot-- Diagnostic Mammogram and ultrasound; Severe Diarrhea for 48hrs following 2nd shot. Pain in arm for about 4 days following both shots
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| 60 | 2021-03-11 | nausea, diarrhea |
Nausea, diarrhea, dizziness, disorientation, shakes, headache, injection site pain - all started aro...
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Nausea, diarrhea, dizziness, disorientation, shakes, headache, injection site pain - all started around 1 pm March 8 and subsided by 8 am March 9
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| 60 | 2021-03-11 | nausea |
Patient administered Covid Vaccine (Pfizer, 1st dose) at approximately 2:46PM. At approximately 150...
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Patient administered Covid Vaccine (Pfizer, 1st dose) at approximately 2:46PM. At approximately 1505 pt c/o nausea and ran outside. Pt awake, alert, respirations easy and unlabored, no distress noted. No vomiting occurred. Pt stated history of throat swelling and facial swelling/rash after PCN. 1510: Pt stated nausea resolved. Pt Diabetic and had not eaten lunch. Juice and crackers given, pt tolerated well with no difficulty. Respirations remain easy and unlabored, no distress. 1517: Pt clearing throat, c/o throat swelling, able to manage oral secretions, speaking in complete sentences. Pt to triage area via wheelchair by RN. BP 171/80 | Pulse 77 | Resp 17 | LMP 02/01/2013 (LMP Unknown) | SpO2 98% 1523: Pt awake, alert, c/o difficulty breathing. RN called for assistance 1526: 911 called. BP 184/84 | Pulse 82 | Resp 20 | LMP 02/01/2013 (LMP Unknown) | SpO2 100% 1528: RN called ED MD, Dr., verbal order received for Epinephrine 0.3 mg subcutaneous one time now. 1530: Epinephrine given per MD order. 1532: EMS crew on scene, Sac City 7, assessing patient, full report given by RN. During transfer of care, pt started shaking, full body, eyes closed, assisted to supine position on gurney by EMS crew, no injuries occurred, very short duration- pt aroused. Pt and her personal belongings to ED by EMS crew.
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| 60 | 2021-03-11 | vomiting, diarrhea, nausea |
Fatigue starting at 20:25 on 1/27/2021. Ended on arising on 1/29/2021 at 0530 Nausea with vomiting...
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Fatigue starting at 20:25 on 1/27/2021. Ended on arising on 1/29/2021 at 0530 Nausea with vomiting starting at 2200 on 1/27/2021. Continued thru the night and early morning hours stopped at approximately 0930 on 1/28/2021 Diarrhea starting after midnight on 1/28/2021 Ended at 0700 on 1/28/2021
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| 60 | 2021-03-11 | vomiting, nausea | Headache, vomiting, nausea. No fever, but very tired |
| 60 | 2021-03-13 | abdominal discomfort, decreased appetite, vomiting, nausea | Nausea and vomiting, dizziness, stomach upset, no appetite, headache |
| 60 | 2021-03-13 | diarrhea | Severe diahrrea, lightheadedness, headache, legs ached- started around 4:00 pm No treatment |
| 60 | 2021-03-13 | nausea, retching |
2:30 pm pain in left breast and arm pit. Around 3:30 pm slight headache lasting until 6:40 pm. 12:...
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2:30 pm pain in left breast and arm pit. Around 3:30 pm slight headache lasting until 6:40 pm. 12:50 am woke to hot sweating and cold lightheaded and dizzy, nauseous and dry heaves. Rash on shot spot and surrounding area. Skin peeling at bandage area. 11:00 am shot area sore. Bandage area still a rash and slight peeling of skin.Dizziness is gone and nausea is gone. No headache
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| 60 | 2021-03-13 | nausea | Chills, headache, nausea, body aches and fatigue |
| 60 | 2021-03-14 | diarrhea |
swollen lymph nodes; tiredness; diarrhea; This is a spontaneous report from a contactable consumer (...
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swollen lymph nodes; tiredness; diarrhea; This is a spontaneous report from a contactable consumer (patient herself). A 60-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 10Feb2021 09:15 at single dose for COVID-19 immunisation in workplace clinic. The patient's medical history included AFib, hypertension, known allergies: TB test (allergies to medications, food, or other products: TB test). Concomitant medications included apixaban, digoxin, metoprolol, enalapril; the patient received all the drugs within 2 weeks of vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), in left arm on 20Jan2021 09:15 AM at single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On an unspecified date in 2021, the patient experienced swollen lymph nodes, tiredness, diarrhea. The events were considered as non-serious by the consumer. No treatment received for the adverse events. The outcome of the events was recovering.
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| 60 | 2021-03-15 | abdominal pain, diarrhea |
About 13 hours after receiving vaccine I awoke close to midnight feeling ill. I spent the next 3 hou...
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About 13 hours after receiving vaccine I awoke close to midnight feeling ill. I spent the next 3 hours having bouts of diarrhea every 5 to 10 minutes along with chills and feeling hot and abdominal pain. This morning on the 16 of March I feel okay with some fatigue and sore right shoulder at injection site.
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| 60 | 2021-03-15 | difficulty swallowing |
my tongue was tingling and was slightly swollen; difficulty swallowing saliva but could swallow wate...
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my tongue was tingling and was slightly swollen; difficulty swallowing saliva but could swallow water; my tongue was tingling and was slightly swollen; I felt some tingling in my face; I felt light headed right after the shot; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection; Lot Number: EM9810), via an unspecified route of administration in the left arm on 04Feb2021 at 16:15 (at the age of 60-years-old) as a single dose for COVID-19 vaccination. Medical history included depression, anxiety and the patient was diagnosed with COVID-19 prior to vaccination. No allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included 6 prescribed meds daily plus vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient was not tested for COVID-19. Upon vaccination on 04Feb2021 at 16:15, patient felt light headed right after the shot. She waited 15 minutes and started driving home. she felt some tingling in her face. By the time she got home, 35 minutes after the shot, her tongue was tingling and was slightly swollen. She had some difficulty swallowing saliva but could swallow water. Her tongue was still slightly swollen the next morning but did not tingle. No seriousness criteria was reported. The patient did not receive any treatment for the events. The outcome of events was recovered on an unspecified date of Feb2021.
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| 60 | 2021-03-15 | nausea |
Within the first 30 min of receiving first COVID vaccine pt report feeling dizzy and nauseated. Pt t...
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Within the first 30 min of receiving first COVID vaccine pt report feeling dizzy and nauseated. Pt taken to vaccine clinic observation area to be closely monitored. Pt placed on gurney and given water to drink. VS stable. Pt report headache 5/10, feeling sensitive to light, and nauseated. While in observation area pt reports feeling what she describes as "feeling weird wavey sensation over entire body, warm head, and cool body." Pt offered but declined to go to ED. explained risks and benefits to pt. Pt states that she drove herself to vaccine clinic. Pt advised that it it would be unsafe to drive herself home and advised to to contact husband for ride home. Pt called her husband to pick her up. After several min pt states stated that she was "feeling a little better" and "headache was also a little better" 3/5 on pain scale but still feeling dizzy and chest feeling a little tight. " Pt states having a history of Asthma. Pt again offered to be treated in ED and accepted. Pt transported to ED by gurney accompanied by three RN's.
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| 60 | 2021-03-15 | nausea | Headache, nausea, fatigue |
| 60 | 2021-03-15 | vomiting, diarrhea |
15 hours after vaccination sever diarrhea and vomiting, which lasted 8 hours. Chills and shaking. Fe...
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15 hours after vaccination sever diarrhea and vomiting, which lasted 8 hours. Chills and shaking. Fever that climbed to 102.7 and lasted 24 hours. Took acetaminophen. Fever back to normal on 3/16/2021, four days after the vaccination.
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| 60 | 2021-03-16 | abdominal discomfort | left arm soreness, headache, upset stomach, tired |
| 60 | 2021-03-16 | decreased appetite |
12 hours post vaccine, began to experience extreme chills, hyperventilation, breathing difficulties,...
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12 hours post vaccine, began to experience extreme chills, hyperventilation, breathing difficulties, and fever of 103. Couldn't talk due to chills without extreme stuttering. Ended up being transported to a local ER for care where I remained for approximately 7 hours. Was given IV fluids and Toporol to control fever. Fever persisted for 72 hours, loss of appetite and extreme fatigue. Now 7-days post 2nd shot and still experiencing fatigue.
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| 60 | 2021-03-16 | diarrhea |
Just a few hours after receiving my first Vaccine, I started running a fever of 99.9, Got real sick ...
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Just a few hours after receiving my first Vaccine, I started running a fever of 99.9, Got real sick at my stomach, started have Diarrhea, Severe Headache, My arm hurt really bad could not use it for a Day and 1/2. Just felt like I had been run over by a Bulldozer.
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| 60 | 2021-03-16 | difficulty swallowing |
The event began with me feeling extremely cold and unable to warm up. It later progressed to needle...
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The event began with me feeling extremely cold and unable to warm up. It later progressed to needle like sensations where ever touched. I do not remember the next week. Per my husband I had a sustained temp of 102 and was difficult to keep hydrated. My O2 sats remained stable. The following week I became unable to drink anything thicker than water. This has improved but continues to this day. My husband is a physician.
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| 60 | 2021-03-16 | nausea |
Beginning on the second day after the patient first vaccine she began experiencing fever up to 102.5...
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Beginning on the second day after the patient first vaccine she began experiencing fever up to 102.5, body aches, headache, profound fatigue, chills and nausea. She came to my clinic as this is her 9th (ninth) day of experiencing fevers and fatigue. The other symptoms have resolved.
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| 60 | 2021-03-16 | nausea |
Fifteen minutes after vaccination pt c/o lightheadedness; symptoms progressed w moderately severe he...
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Fifteen minutes after vaccination pt c/o lightheadedness; symptoms progressed w moderately severe headache and nausea. She was hemodynamically stable no signs of any allergic reaction. There are concerns her V-P shunt is not working properly. After lying in a recumbent position for 30+ minutes headache worsened. We elected to transport to ER, via ambulance so she was recumbent during transport.
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| 60 | 2021-03-16 | nausea | Dizzyness, nausea, severe headache, painful arm, sore throat, fatigue. |
| 60 | 2021-03-17 | abdominal pain upper, vomiting, nausea, diarrhea |
This is a 60 year old female was brought into emergency department as cardiac arrest. Patient was s...
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This is a 60 year old female was brought into emergency department as cardiac arrest. Patient was seen at care now urgent care with the complain of epigastric pain associated with nausea vomiting and intermittent diarrhea. Patient received her initial COVID vaccine 2 days ago. History is obtained from urgent care chart. As per notes patient started nausea vomiting 6 hours post COVID vaccine administration. Patient was seen in urgent care for epigastric pain and nausea vomiting. Patient was found unresponsive at 0902 by tech. No carotid pulses palpated. CPR was started. Patient was brought into the emergency department with Lucas on. Patient was given 5 epinephrine prior to arrival. CPR was in progress. Patient was asystole. Resuscitation was continued in the ED. Patient was intubated in the ED by physician assistant 5 epinephrine 2 bicarb and 1 calcium chloride was given in the ED. Cardiac Ultrasound didn't show any cardiac activity. Asystole on the monitor. No corneal reflex people are fixed and dilated. Patient was pronounced at 1007 am
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| 60 | 2021-03-17 | nausea | Strong nausea for about an hour. It seems to be dissipating. |
| 60 | 2021-03-17 | nausea |
After about 10 minutes felt head pressure and light headedness. Reclined patient - lightheadedness r...
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After about 10 minutes felt head pressure and light headedness. Reclined patient - lightheadedness resolved; slight nausea when leaving - felt much better
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| 60 | 2021-03-18 | diarrhea |
Arm was sore at bedtime. By the morning, I could barely move my right fingers. Very sore and tired ...
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Arm was sore at bedtime. By the morning, I could barely move my right fingers. Very sore and tired the day after. I was incredibly sore everywhere - back,chest, hips, legs, neck... very hard to move. Around 5 PM the day after the vaccination, I became violently ill. Diarrhea, chills, feverish, sweating. etc. This lasted until about 3 AM on the 18th.
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| 60 | 2021-03-18 | difficulty swallowing |
pt. called stating she recieved her first COVID vacc. past weekend, now having swollen lymph nodes a...
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pt. called stating she recieved her first COVID vacc. past weekend, now having swollen lymph nodes and trouble swallowing. Pt. was advised to go to UC or ER. Pt. presenting today for Swollen glands (had 1st dose vaccine on Saturday, Monday started having swollen glands in neck
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| 60 | 2021-03-18 | nausea, abdominal pain, vomiting |
Dizzy; Nausea; Vomit; Pain on all body; Frequent fall; Severe fatigue; Strange feeling; Abdominal pa...
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Dizzy; Nausea; Vomit; Pain on all body; Frequent fall; Severe fatigue; Strange feeling; Abdominal pain on and off; Arrhythmia; This is a spontaneous report from a contactable physician. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in left arm on 11Feb2021 09:00 (batch/lot number was not reported) as single dose for COVID-19 immunisation. Medical history included (G60.9) PN - Peripheral neuropathy (SCT42658009), (M79.2) A Neuralgia (SCT16269008), (R55) Syncope (SCT271594007), (I10) HTN - Hypertension (SCT38341003), (R00.0) Tachycardia (SCT3424008), (E16.2) Hypoglycemia (SCT302866003), (R55) Vasovagal symptom (SCT248229009), (M25.50) Joint pain (SCT57676002), (F41.9) Anxiety (SCT48694002), (K21.9) Acid reflux (SCT235595009), and (M06.4) Polyarthritis (SCT416956002); all were current or ongoing. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 12Jan2021 for COVID-19 immunization (product: COVID 19, brand: Pfizer, administration time: 09:00 AM, route: intramuscular, vaccine location: left arm). On 11Feb2021 11:00, the patient experienced dizzy, nausea, vomit, pain on all body, frequent fall, severe fatigue, strange feeling, abdominal pain on and off, and arrhythmia. The AEs resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. There were no treatments given for the events. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID post vaccination. The patient has no known allergies. No other vaccines received within four weeks prior to COVID vaccine. The events were reported as serious and disabling. The patient has not recovered from all the events. Information on the lot/batch number has been requested.; Sender's Comments: Drug causality for suspect drug in the onset of the reported events cannot be excluded assuming a plausible temporal association and considering the known safety profile of the product. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 60 | 2021-03-18 | nausea |
Body aches; fever (100.5); chills; nausea; headache; This is a spontaneous report from a contactable...
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Body aches; fever (100.5); chills; nausea; headache; This is a spontaneous report from a contactable consumer, the patient (patient). A 60 -years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN6201), via an unspecified route of administration in the left arm on 12Feb2021 at 14:15 as a single dose, for COVID-19 immunization. Historical Vaccine includes BNT162B2, Dose 1, Lot number EL8982, Administered on 22Jan2021 at 14:30 in the right arm. Medical history included Allergy: Egg intolerance. Concomitant medication includes Prempro, and multi vitamin. The facility in which the vaccine was administered No other vaccines were given within 4 weeks. On 13Feb2021 at 13:00 the patient experienced Body aches, fever (100.5), chills, nausea, headache. No treatment was given for the events. Lab data includes Body temperature 100.5 on 13Feb2021. The clinical outcome of the events Body aches, fever (100.5), chills, nausea, headache were not recovered.
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| 60 | 2021-03-18 | nausea |
Day 1 (3/7): sore arm, mild headache, fatigue, nausea Day 2 (3/8): more sore arm, mild headache, fat...
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Day 1 (3/7): sore arm, mild headache, fatigue, nausea Day 2 (3/8): more sore arm, mild headache, fatigue Day 3: unable to lift left arm, headache Day 4: sore arm, 3" oval shaped red spot next to shot spot: swollen, raised, itch Day 5: arm better, red spot still itch Day 6: able to lift arm, less sore, red spot smaller, still itch, shot spot still itch too Day 7: arm almost back to normal, red spot diasppeared Day 8: all 10 toes red, swollen, extremely itch, unbearable especially at night Day 9 - 10: different toes itch more each night Day 11 (3/17): visited urgent care - diagnosed fungal infection Day 11: visited Primary Care Physician : referral to visit Podiatrist Day 13 (3/19): visited Podiatrist - diagnosis COVID Pfizer Vaccine side effect, prescription: Betamethasone
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| 60 | 2021-03-18 | vomiting, abdominal distension, diarrhea |
I started throwing up and had diarrhea by around 10 pm, did that about 4 times, my stomach was so bl...
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I started throwing up and had diarrhea by around 10 pm, did that about 4 times, my stomach was so bloated, it was weird. The next day, couldn?t get out of bed, all I had yesterday was diarrhea and felt like someone kicked me in the ribs. Today I am having a hard time taking a deep breathe or coughing without my ribs hurting so bad. My stomach feels better. Haven?t eaten anything, I am more concerned about under my breast hurt so much when I take a deep breathe or cough. I haven?t gone to doctor because I just wonder if it hurts so much there because if the vomiting
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| 60 | 2021-03-19 | nausea | Headache, injection site pain, nausea, tiredness, joint pain |
| 60 | 2021-03-19 | nausea |
swelling where shot was given and could not lift my arm for 2 days. Nausea for 2 days and really ...
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swelling where shot was given and could not lift my arm for 2 days. Nausea for 2 days and really tired.
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| 60 | 2021-03-19 | nausea | Fever , chills, headache, body ache, nausea |
| 60 | 2021-03-19 | nausea | Fatigue malaise headache nausea on March 19 all day ... fine on March 20 |
| 60 | 2021-03-19 | retching, nausea |
Felt lousy about hr after arm tender to lift up, ,headache,then jaw pain w worsened malaise,nausea, ...
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Felt lousy about hr after arm tender to lift up, ,headache,then jaw pain w worsened malaise,nausea, violent headache, chills fevers ,dry heaves, red and hot arm developed after couple days lasted about six days spread to 4x6 inches got itchy then sore to touch. Became vague and almost disoriented, had to sleep due to overwhelming fatigue w vile headache
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| 60 | 2021-03-19 | vomiting, abdominal pain, diarrhea, nausea |
Pt was admitted 6 weeks post second covid vaccination with c/o sudden onset of generalized abdominal...
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Pt was admitted 6 weeks post second covid vaccination with c/o sudden onset of generalized abdominal pain, nausea, vomiting and diarrhea resulting in 2 syncopal episodes. CBC showed leukocytosis with neutrophilia which resolved. She was treated with IV fluids and antiemetics and was discharged on 3/19/2021
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| 60 | 2021-03-20 | decreased appetite |
I felt fine when I woke up. My left arm was very sore which also was the case after first vaccine. A...
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I felt fine when I woke up. My left arm was very sore which also was the case after first vaccine. Around 10 am I developed chills and just did not feel great. My husband took my temp and the highest it got was 102.6 which is high for me since my baseline is 97.6 or so. I did not have a great appetite and felt very stiff when I moved around. I pushed fluids and took 3 naps Saturday. I have a low grade fever of 99 today but feel much better. Did take 2 naps and slept well last night. Took Advil with each meal and doing so today.
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| 60 | 2021-03-20 | nausea, diarrhea |
nausea & lightheadedness (10 minutes), diarrhea (one instance), fatigue (2 days), headache (1,5 days...
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nausea & lightheadedness (10 minutes), diarrhea (one instance), fatigue (2 days), headache (1,5 days), sore injection site (1 day)
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| 60 | 2021-03-20 | nausea |
Same symptoms as when I had Covid in November 2020. Extreme fatigue, headache, nausea, sinus congest...
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Same symptoms as when I had Covid in November 2020. Extreme fatigue, headache, nausea, sinus congestion, severe flu-like symptoms. These lasted 48 hours.
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| 60 | 2021-03-20 | nausea |
COVID Vaccine clinic. Per chart review, pt received COVID vaccine at 1426. At approximately 1505 p...
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COVID Vaccine clinic. Per chart review, pt received COVID vaccine at 1426. At approximately 1505 pt c/o nausea and ran outside. Pt awake, alert, respirations easy and unlabored, no distress noted. No vomiting occurred. Pt stated history of throat swelling and facial swelling/rash after PCN. 1510: Pt stated nausea resolved. Pt Diabetic and had not eaten lunch. Juice and crackers given, pt tolerated well with no difficulty. Respirations remain easy and unlabored, no distress. 1517: Pt clearing throat, c/o throat swelling, able to manage oral secretions, speaking in complete sentences. Pt to triage area via wheelchair by RN. BP 171/80 | Pulse 77 | Resp 17 | LMP 02/01/2013 (LMP Unknown) | SpO2 98% 1523: Pt awake, alert, c/o difficulty breathing. RN called for assistance, attempted to located on site MDs. 1526: No MDs on site, 911 called. BP 184/84 | Pulse 82 | Resp 20 | LMP 02/01/2013 (LMP Unknown) | SpO2 100% 1528: RN called ED MD, Dr., verbal order received for Epinephrine 0.3 mg subcutaneous one time now. 1530: Epinephrine given per MD order. 1532: EMS crew on scene, Sac City 7, assessing patient, full report given by RN. During transfer of care, pt started shaking, full body, eyes closed, assisted to supine position on gurney by EMS crew, no injuries occurred, very short duration- pt aroused. Pt and her personal belongings to ED by EMS crew.
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| 60 | 2021-03-20 | nausea |
Fever (fluctuated between 99 and 102 degrees), chills, achy body, nausea, headache for approximately...
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Fever (fluctuated between 99 and 102 degrees), chills, achy body, nausea, headache for approximately 12-15 hours did not feel well. The next morning (Sunday 3/21) woke up nauseous and had trouble breathing. Went outside for cold air and breathing was OK.
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| 60 | 2021-03-21 | decreased appetite |
Loss of appetite morning after vaccine, headache, body aches, chills, face flushed. Fever started af...
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Loss of appetite morning after vaccine, headache, body aches, chills, face flushed. Fever started afternoon. 99.4. Took Tylenol but it gradually rose to 102.3. Took 3 hours for fever to go down. By 5:30 fever was gone & I was feeling better. Next day I felt great but by three days later I had a fever blister & very sore, dry and stuffy nose which lasted two weeks. And headache as well. I?m thinking because of stuffy nose. I did have Covid last March/April 2020 so I have heard that I would have side effects.
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| 60 | 2021-03-21 | diarrhea |
Due to 4 days progressive worsen skin lesion. Lesion as erythema multiform, generalized on hand, for...
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Due to 4 days progressive worsen skin lesion. Lesion as erythema multiform, generalized on hand, forearm, body and lower leg; Oral ulcer; Chill; Body ache; Joint pain; Joints swelling; Diarrhea; This is a spontaneous report from a contactable other healthcare professional (HCP). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6201), via unspecified route of administration in the left arm on 17Feb2021 as single dose for COVID-19 immunization. Medical history included hyperlipidemia. The patient had no known allergies. The patient is not pregnant. There were no vaccine in four weeks. Other medications in two weeks included cholesterol med. The previously received the first dose of BNT162B2 on 26Jan2021 12:00 intramuscular at left arm (lot number: EL9262) for COVID-19 immunization. The patient was seen at urgent care on 04Mar2021 due to 4 days progressive worsened skin lesion. Lesion as erythema multiform, generalized on hand, forearm, body and lower leg from 28Feb2021 (12:00 AM). Patient presented with chill, body ache, joint pain, joints swelling and diarrhea since second dose of vaccine on 17Feb2021. She also has oral ulcer at the same time when rash started on 28Feb2021. Vital sign was stable, no shortness of breath (SOB) and no chest pain. Events resulted in Doctor or other HCP office/clinic visit. The treatment for the events included Hydroxyzine 25 mg prn. It was unknown if patient had COVID prior vaccination or if COVID tested post vaccination. The outcome of the events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Erythema multiforme cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 60 | 2021-03-21 | nausea | Chills, musculoskeletal pain, headache, sinus pain, nausea, tooth sensitivity |
| 60 | 2021-03-21 | nausea |
extreme fatigue, headache, nausea, muscle aches, joint pain, low grade fever, chills, swollen lymph ...
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extreme fatigue, headache, nausea, muscle aches, joint pain, low grade fever, chills, swollen lymph nodes in neck and under arm, treatment was motrin 600 mgs q6hrs from 2/18/21-02/22/21 returned to work on 02/23 lymph nodes still slightly enlarged as of today, 03/22/21
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| 60 | 2021-03-21 | nausea |
After about 20 minutes felt head pressure and lightheadedness, Reclined patient, light headedness re...
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After about 20 minutes felt head pressure and lightheadedness, Reclined patient, light headedness resolved. Slight nausea when leaving felt much better. VS 168/90; 73; 97%SaO2
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| 60 | 2021-03-21 | stomatitis |
Sialadenitis (salivary gland inflammation); glossitis (tounge inflammation); inflammation of the muc...
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Sialadenitis (salivary gland inflammation); glossitis (tounge inflammation); inflammation of the mucosal lining of the oral cavity with cherry red discoloration and swelling of the lips; inflammation of the mucosal lining of the oral cavity with cherry red discoloration and swelling of the lips; inflammation of the mucosal lining of the oral cavity with cherry red discoloration and swelling of the lips; Tingling; prickly sensation on tongue when eating; cold items felt opposite of what they should, more like burning sensation; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6202), via an unspecified route of administration in the left arm on 27Feb2021 12:45 as single dose for COVID-19 immunization. Medical history included known allergies to Sulph. The patient was not pregnant. Concomitant medications included aceclofenac (BIOFLEX [ACECLOFENAC]), calcium (CITRICAL [CALCIUM]) and vitamin D (VITAMIN D [VITAMIN D NOS]). On 01Mar2021 08:00, the patient experienced sialadenitis (salivary gland inflammation), glossitis (tounge inflammation), inflammation of the mucosal lining of the oral cavity with cherry red discoloration and swelling of the lips. Tingling, prickly sensation on tongue when eating, cold items felt opposite of what they should, more like burning sensation were also reported. Onset of symptoms Monday morning, symptoms peaked Wednesday evening through midday Thursday, greatly improved by Friday morning. The patient had a COVID test on Friday to be sure and it was negative. There were no treatment for events. No COVID prior vaccination. The patient had a COVID test type post vaccination-Nasal Swab (Covid 2 PCR) on 05Mar2021 which was negative. The patient had The outcome of the events was recovered on unspecified date in Mar2021.
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| 60 | 2021-03-22 | nausea, vomiting, abdominal discomfort |
EUA Phizer-BioNtech vaccine reaction. patient reported vomiting associated with nausea and abdominal...
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EUA Phizer-BioNtech vaccine reaction. patient reported vomiting associated with nausea and abdominal discomfort s/p getting the covid
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| 60 | 2021-03-22 | nausea |
At about 3:55PM my left arm, where injectiion was administered began tingling from upper arm to fing...
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At about 3:55PM my left arm, where injectiion was administered began tingling from upper arm to fingers. Pain to the back of my neck, a flush of warmth to my upper body and difficulty breathing. Felt like a truck ran over my chest. I was weak, dizzy and nauseous as well. The tingling sensation also affected both my legs. The RN took to their infirmary area and began taking my vitals. Vitals seems normal, Blood Pressure and Pulse were high. I am asthmatic but did not bring my inhaler with me. Because of my difficulty breathing, they decided to inject me with Benadryl which is all they had. After about twenty minutes, my breathing started to calm down and blood pressure began coming down as well.
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| 60 | 2021-03-22 | nausea | DIzzyness and mild nausea |
| 60 | 2021-03-22 | nausea |
March 21 I had fever 101 , fatigue, nausea, body aches, headache that kept me from my daily function...
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March 21 I had fever 101 , fatigue, nausea, body aches, headache that kept me from my daily functions. Reporting app did not ask about that date and I want to report that was a bad day. I did not seek medical treatment. Treated with ibuprofen and rest
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| 60 | 2021-03-22 | nausea | Severe headache 101 temp Nausea Intense pain at injection site Intense body pains |
| 60 | 2021-03-22 | nausea |
Flu-like symptoms: headache, fatigue, dizziness, nausea, swollen lymph nodes, sore arm beginning th...
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Flu-like symptoms: headache, fatigue, dizziness, nausea, swollen lymph nodes, sore arm beginning the evening of injection. All symptoms, except sore arm, gone by morning. No treatment given.
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| 60 | 2021-03-23 | diarrhea, abdominal discomfort |
Received the first vac on 3/12 at 8:30 a.m.. I started feeling achy and tired by 4pm. By the next da...
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Received the first vac on 3/12 at 8:30 a.m.. I started feeling achy and tired by 4pm. By the next day, I had diarrhea and stomach upset starting by mid day. Since then, I have had daily diarrhea, lethargy, weakness, off and on headache, body aches (especially joints) and overall feeling of unwell.
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| 60 | 2021-03-23 | diarrhea |
I was submitting my events daily on website and two days it tells me my session has expired and won'...
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I was submitting my events daily on website and two days it tells me my session has expired and won't let me report anything. On Sunday night, March 21st, I started with very painful joint and muscle aches with fatigue. The next morning I felt terrible and could barely function, I had a bought with diarrhea that lasted almost the entire day and had no energy. I developed a large lump on my left clavicle area that seemed to be filled with fluid. My knees I had replaced are still very painful today ( 7 days post vaccine). I phoned my Dr. yesterday and they told me to take 1000mg of Tylenol 3 times a day. I am doing this now for the second day with some relief. I feel this is very unusual to feel this way 7 days after the vaccine. On day 1-2 the only symptoms were a sore arm from the vaccine. Saturday was actually a good day with no symptoms, the other symptoms started on Sunday. I feel like my heartbeat is irregular also but my BP is good. I would like to be able to to report daily on v-safe like I was the first few days.
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| 60 | 2021-03-23 | diarrhea | Headache, eyes burned, diarrhea |
| 60 | 2021-03-23 | diarrhea |
Symptoms were minor--soreness at injection site for 2 days, loose stool the day after injection, and...
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Symptoms were minor--soreness at injection site for 2 days, loose stool the day after injection, and minor headache and fatigue on the day after injection through the following day (2 days after injection).
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| 60 | 2021-03-23 | nausea |
20 hours of terrible body aches, headache, chills, nausea. Fever (that got up to 100.2) for 12 hours...
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20 hours of terrible body aches, headache, chills, nausea. Fever (that got up to 100.2) for 12 hours.
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| 60 | 2021-03-24 | diarrhea, nausea |
this was my 2nd dose. late afternoon & was feeling unenergetic. late that eve I felt achy, took 400m...
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this was my 2nd dose. late afternoon & was feeling unenergetic. late that eve I felt achy, took 400mg ibuprofen before going to bed around 11pm. by 1 am on 3/24 I was running a fever, shivering & my inj arm was very sore/felt heavy. Took 400 more ibuprofen, fever reduced before too long. Also felt slightly nauseous during the night & into the day of 3/24. around 2 pm got a bad headache. more ibuprofen, still felt a little nauceous, tho that subsided in early a.m. 3/25. Also was coughing quite q bit most of 3/24, but that may have been due to allergy stuff. experienced some mild diarrhea on 2 occassions 3/24. Symptoms are fairly well abated by 10a.m. 3/25.
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| 60 | 2021-03-24 | nausea | Fever, 100 F. Chills Nausea Sore Arm |
| 60 | 2021-03-25 | diarrhea |
gradual onset of diarrhea and fever 2 days after injection for a duration of 4 days. fever of 101, c...
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gradual onset of diarrhea and fever 2 days after injection for a duration of 4 days. fever of 101, chills diarrhea and inflammation under left arm and breast.
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| 60 | 2021-03-25 | diarrhea |
seven minutes after injection my skin felt flushed and hot around my upper back, neck, shoulders, I ...
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seven minutes after injection my skin felt flushed and hot around my upper back, neck, shoulders, I felt dizzy and then had diarrhea this continued off and on for several hours...in the ER they gave me steroid, saline solution for dehydration and pepcid. I had a headache and chills while in the ER. Went home and felt fine that night other than mild headache.
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| 60 | 2021-03-25 | nausea, vomiting, diarrhea | Nausea, Vomit/Diarrhea, Chills (very cold head to toes), body/joints ache, stiff throat |
| 60 | 2021-03-25 | nausea |
things went black; my blood pressure was alarmed was over 200 checked other arm same called there te...
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things went black; my blood pressure was alarmed was over 200 checked other arm same called there team ER member to triage still B/P high; severe dizziness; severe headache nausea; weakness; severe headache nausea; This is a spontaneous report from a contactable other healthcare professional (patient). An 60-year-old non-pregnant female patient received bnt162b2 (COVID 19, brand: Pfizer, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 07Feb2021 11:00 (Batch/Lot Number: EL9264) as SINGLE DOSE for covid-19 immunisation. Medical history included Stent in LAD (Left anterior descending coronary artery). Concomitant medications included losartan potassium, lorazepam (ATIVAN), acetylsalicylic acid (BABY ASPIRIN) and furosemide. It was reported that, within 15-20 minutes went to stand up severe dizziness and things went black started to get severe on 07Feb2021 at 11:15 AM. On 07Feb2021 at 11:15 AM, Headache, nausea Nurse Practitioner that gave shot took her blood pressure was alarmed was over 200 checked other arm same called there team ER member to triage still B/P high and she could not stand up due to weakness dizziness apparently they called Paremedic/EMT advised in her best interest to be seen in Emergency department. they did not how ever ask if she belonged to a ambulance company which she do so know she have a bill of about 1,500 with ambulance company. was in the ED for about 4 hours till blood pressure can down. was given medication for nauseas, felt like she was hit by a truck. Patient had Cardiac montering/medication. No covid prior to vaccination. No covid tested post vaccination. Outcome of events was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The events assessed as possibly related to the suspect drug BNT162B2______ based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 60 | 2021-03-25 | nausea |
Initially, mild nausea, immediately (with 15 minutes of administration) . Resolved promptly within 3...
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Initially, mild nausea, immediately (with 15 minutes of administration) . Resolved promptly within 30 minutes of injection. Then, three hours after administration (at approx. 12.30 p.m.), the following symptoms in order of severity: 1. Severe tiredness/fatigue. Lasted 4 hours. Resolved when I took a half hour nap. 2. Sore throat. Still present at 10.30 pm. 3. Swollen lymph nodes (lymphadenopathy). Significant improvement after 4 hours from onset (3 hours after administration). However, still present at 10.30 p.m. 4. Feeling unwell/malaise. Resolved after I took a nap. 5. Dry eyes. I had to remove my contact lenses and put on eyeglasses when I got home at approx. 2pm. 6. Dry mouth. Unresolved, even with drinking a lot of water and tea. Symptoms were fairly severe. I had to leave work and go home to rest. I was unable to drive myself home.
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| 60 | 2021-03-26 | diarrhea |
Day 1..... couldn't sleep that night Day 2.....fever, chills, bad headache, fell asleep at 4pm and s...
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Day 1..... couldn't sleep that night Day 2.....fever, chills, bad headache, fell asleep at 4pm and slept all night with 800 mg Tylenol. Day 3.....fever, Chills, bad headache, cough, diarreha Day 4..... headache, cough diarreha
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| 60 | 2021-03-26 | nausea |
100? Fever, total body aches, nausea, inflammation, some shortness of breath, chest tightening, fati...
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100? Fever, total body aches, nausea, inflammation, some shortness of breath, chest tightening, fatigue, headache.
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| 60 | 2021-03-26 | nausea |
Within four hours of shot, low grade fever, 101.4, chills, nausea, exhaustion. Asleep by 9:00p.m., s...
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Within four hours of shot, low grade fever, 101.4, chills, nausea, exhaustion. Asleep by 9:00p.m., slept 13 hours, On March 17, woke at 10 am. Nausea, fever, chills gone, but totally exhausted with burning sensation at shot site and soreness in upper right arm. Remained in bed all day, asleep by 6 pm. Remained exhausted through March 23. Any physical activity caused shortness of breath and further tiredness. Exhaustion dissipated by March 24, 2021
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| 60 | 2021-03-26 | retching |
Severe cramping, bloody diarrhea, dry heaves. It calmed for a week, now I have cramping and bloody ...
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Severe cramping, bloody diarrhea, dry heaves. It calmed for a week, now I have cramping and bloody diarrhea again.
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| 60 | 2021-03-26 | vomiting |
Pain in left arm for about 30 min. followed by numbness in hand, then ring finger fingertip complete...
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Pain in left arm for about 30 min. followed by numbness in hand, then ring finger fingertip completely white that lasted about 10 min. Once color returned I soon became dizzy and weak feeling in my legs followed with vomiting. I then felt a little better with mild light headedness.
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| 60 | 2021-03-27 | nausea |
3/25/21 2:00 AM sore throat congestion 3/26/21 3:09 AM. Awoke with chills 101.5 fever, sore throat n...
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3/25/21 2:00 AM sore throat congestion 3/26/21 3:09 AM. Awoke with chills 101.5 fever, sore throat nausea aches cough Continue with very sore throat, fatigue nausea congestion dry cough nasal congestion
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| 60 | 2021-03-27 | nausea | Headache muscle pain tiredness nausea chills Overall not feeling well |
| 60 | 2021-03-27 | vomiting, nausea |
Site: Pain at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness...
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Site: Pain at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: vomiting-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Severe
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| 60 | 2021-03-28 | nausea |
Swollen Lymph Nodes, chills, headache, nauseous stomach, pain radiating in left boob & left back, an...
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Swollen Lymph Nodes, chills, headache, nauseous stomach, pain radiating in left boob & left back, and tireness
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| 60 | 2021-03-30 | indigestion, constipation |
Moderate indigestion; constipation; This is a spontaneous report from a contactable consumer(patient...
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Moderate indigestion; constipation; This is a spontaneous report from a contactable consumer(patient herself). A 60-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE solution for injection; batch/lot number and expiry date were not reported), via an unspecified route of administration on 24Jan2021, 12:00pm (at the age of 60-years-old) at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took acetaminophen and experienced drug hypersensitivity. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient has not been diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. At 4:00pm (16:00) of 25Jan2021, the patient experienced moderate indigestion and constipation. Treatment was not received for the events. The outcome of these events was recovering. The events were reported as non-serious by the reporter. Information on the lot/batch number has been requested.
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| 60 | 2021-03-31 | vomiting, nausea |
3/29/21 around 6pm -Light-headed, dizziness, off-balance when walking, numbness on right side of fac...
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3/29/21 around 6pm -Light-headed, dizziness, off-balance when walking, numbness on right side of face, nausea and vomit once. Went to ER around 12:30am on 3/30/21. Admitted to the Hospital from 3/30/21-3/31/21.
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| 60 | 2021-04-01 | nausea, vomiting |
Shot 3/3/2021 9:05am, headache started around 7:00pm, overnight also had fever and chills. 3/4-Heada...
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Shot 3/3/2021 9:05am, headache started around 7:00pm, overnight also had fever and chills. 3/4-Headache and fever continued, also had nausea and vomiting. On 3/5/3021, other symptoms resolved, but woke with double vision due to 6th cranial nerve palsy. This is the fourth acute occurrence of the nerve palsy. As of today, 4/2/2021, the double vision is still acutely present.
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| 60 | 2021-04-03 | nausea |
12-48 hrs post vaccine: nausea, fever, headache, muscle aches, malaise; took tylenol; 48-96 hrs post...
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12-48 hrs post vaccine: nausea, fever, headache, muscle aches, malaise; took tylenol; 48-96 hrs post: malaise; 5th-10th day post: coronary vasospasms, malaise, arrhythmia; took nitroglycerin patches, nitro bid paste; 11th day: met with rheumatologist, started medrol dose pack, improved spasms for a short time, 13th day: afib symptoms and Apple Watch reading noted by patient; 15th day spasms began again and increased symptoms of afib: saw doctor in office for EKG showing afib; met with cardiologist ordered increase in diltiazem and second medrol dose pack; first 48 hrs on second dose pack improved spasms, by 3rd day spasms significantly increased and constant afib w headache, dizziness, malaise. Visited ER, admitted. cardio version. Reduced dilitiazem, reduced ramipril, increased isosorbide. Continued symptoms with waxing and waning of spasms and atrial fibrillation . Although this is a pre-existing chronic condition, Afib without relief is not normal. Spasms without resolution not normal nor have I experienced an episode of this duration ever.
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| 60 | 2021-04-03 | nausea |
Pt reports onset on nausea and palpitations approximately 10 hours after receiving first dose of vac...
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Pt reports onset on nausea and palpitations approximately 10 hours after receiving first dose of vaccine. Pt reports Emergency room visit, where she states she was diagnosed with atrial fibrillation. Pt reports she underwent 3 days of hospitalization, converting spontaneously without treatment to normal sinus rhythm.
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| 60 | 2021-04-05 | nausea | Became nauseated has itchy throat and chest tightness with in 5 mins of receiving the vaccine |
| 60 | 2021-04-06 | difficulty swallowing |
My throat was itchy in between that half hour my voice started to change; my throat felt worse; I ha...
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My throat was itchy in between that half hour my voice started to change; my throat felt worse; I have wheezing in my lungs; I still have problem swallowing a little bit; My throat was itchy in between that half hour my voice started to change; my throat felt worse; This is a spontaneous report from a contactable consumer (reporting for herself). A 60-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 15Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included anxiety, depression, neuralgia, heart, blood pressure issue and lot of allergies. Concomitant medication included levothyroxine; atorvastatin calcium (CHOLESTAT [ATORVASTATIN CALCIUM]); pantoprazole; ciprofloxacin hydrochloride, tinidazole (FLOXAZOLE); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); lubiprostone (AMITIZA); thioctic acid (ALPHA LIPOIC ACID); baclofen; linezolid (ZENIX [LINEZOLID]); ascorbic acid, calcium, minerals nos, retinol, tocopheryl acetate, vitamin b nos, vitamins nos, zinc (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]); rosuvastatin calcium (CRESTOR); docusate sodium (STOOL SOFTENER); benazepril hydrochloride, hydrochlorothiazide (BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) taken for heart; desvenlafaxine succinate (PRISTIQ) taken for anxiety, depression; citalopram; venlafaxine hydrochloride (EFFEXOR) taken for anxiety; escitalopram oxalate (LEXAPRO); cyclobenzaprine; gabapentin taken for neuralgia; metoprolol taken for heart; amlodipine taken for blood pressure issue; magnesium oxide. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Feb2021 for COVID-19 immunization and experienced pulse rate would not go down. On 15Mar2021, it was reported that they had it done at the hospital, then after 15 minutes, her throat was itchy the may say another half hour in between that half hour, her voice started to change and her throat felt worse. They walk me down to the ER my throat was hurting then slowly they gave me Epi Pen and they injected in an IV with steroids. The have wheezing in her lungs and spent the night in hospital for observation. They did all kind of blood work, when she was placed in ER. The patient reported that she still have problem swallowing a little bit and voice changes after talking. The outcome of the event "still have problem swallowing a little bit" was not recovered while the outcome of the other events was unknown. Information on the lot/batch number has been requested.
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| 60 | 2021-04-09 | vomiting, diarrhea |
vomiting; diarrhea/Lingering diarrhea into second day; ringing in my left ear. LOUD!; excessive urin...
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vomiting; diarrhea/Lingering diarrhea into second day; ringing in my left ear. LOUD!; excessive urination; eyes feeling like they were popping out; tunnel vision; 104 fever; severe chills and quaking; severe chills and quaking; the worst headache in my life/slight headache on the back of my head, and continued into today; felt like broken shins; hip joints on fire; This is a spontaneous report from a contactable consumer herself (patient). A 60-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 22Mar2021 (Batch/Lot Number: EN6204) Solution for injection as Single Dose for covid-19 immunisation. Medical history included asthma, mild HP (Hypersensitivity pneumonitis) and I am fat. Concomitant medications included lovastatin, eszopiclone (LUNESTA), lisinopril and gabapentin. The patient previously took first dose of BNT162B2 (EN6198), on Left arm on 27Feb2021 for Covid-19 immunization. On 23Mar2021 02:00 patient experienced 104 fever, severe chills and quaking, the worst headache in my life, what felt like broken shins another friend said she had this as well, hip joints on fire, eyes feeling like they were popping out, vomiting after hours 26, tunnel vision, excessive urination, diarrhea started at hour 28. Lingering diarrhea into second day, slight headache on the back of her head, and continued into today, ringing in her left ear. The patient underwent lab tests and procedures which included body temperature: 104 on 23Mar2021. Patient did not test covid post vaccination. Patient did not have covid prior vaccination. The outcome of all events was recovered with sequelae.
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| 60 | 2021-04-14 | abdominal pain |
One week after receiving the first vaccine, I developed severe headaches. I got my booster 21 days l...
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One week after receiving the first vaccine, I developed severe headaches. I got my booster 21 days later. One week after receiving the booster, I started having severe headaches, severe neck, back and abdominal pain. I went to the ED the morning of 3/5/21, was admitted to the hospital and release on 3/8/21. It is in the H&P from Health facility.
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| 60 | 2021-04-15 | indigestion, diarrhea, vomiting |
Severe digestion problems -- vomiting and diarrhea. Continued for several days so went to hospital ...
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Severe digestion problems -- vomiting and diarrhea. Continued for several days so went to hospital where CT showed inflammation of colon. Received IV and antiobiotics; released after three days. No fever or other symptoms. Mostly better now.
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| 60 | 2021-04-16 | nausea, vomiting | Nausea vomiting throughout the day and continuous the next night, sense on impending doom |
| 60 | 2021-04-18 | nausea |
4/4/ Patient returned to the ED with SOB, cough and home pulse ox readings in the 80's. She was star...
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4/4/ Patient returned to the ED with SOB, cough and home pulse ox readings in the 80's. She was started on O2 at 2L NC and was admitted on IV Remdesivir and Decadron. By 4/8, she was able to be weaned off O2 and completed 4 days of Remdesivir and Decadron therapy. She refused rx to complete 10 day course of Decadron due to concerns regarding hyperglycemia and her diabetes.
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| 60 | 2021-04-18 | vomiting, abdominal discomfort, diarrhea, appendicitis, abdominal pain upper |
appendix had ruptured; diagnosed with appendicitis; could barely stand; I felt tired; sore arm; enti...
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appendix had ruptured; diagnosed with appendicitis; could barely stand; I felt tired; sore arm; entire intestinal tract and stomach became hard; extended and felt like it was on fire and was extremely painful; vomiting along with diarrhea; vomiting along with diarrhea; pain and burning in my stomach and back; pain and burning in my stomach and back; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 29Mar2021 12:15 (Batch/Lot Number: EP6955) as single dose (at the age of 60-year-old) for COVID-19 immunisation, administered at Pharmacy or Drug Store. Medical history included known allergies: Sulfa drugs, aspirin cordisone. Patient had not COVID prior vaccination. Patient was not pregnant. Concomitant medication(s) included thyroid (ARMOUR THYROID) taken for an unspecified indication, start and stop date were not reported. The patient previously took aspirin [acetylsalicylic acid] and experienced drug hypersensitivity, cortisone and experienced drug hypersensitivity. No other vaccine in fourweeks. On 29Mar2021 19:30 the patient experienced she felt tired, sore arm, entire intestinal tract and stomach became hard, extended and felt like it was on fire and was extremely painful, vomiting along with diarrhea, pain and burning in my stomach and back. On 31Mar2021 the patient experienced appendix had ruptured, diagnosed with appendicitis, could barely stand. The patient was hospitalized for appendix had ruptured and diagnosed with appendicitis for 2 days. The events were considered serious as per hospitalization, disability, life threatening. Therapeutic measures were taken as a result of appendix had ruptured and diagnosed with appendicitis: appendectomy. COVID was not tested post vaccination. Course of events was as follows: She had the shot on 29Mar2021 at 12:15, 4 hrs after she felt tired and had sore arm. 7 hours after, her entire intestinal tract and stomach became hard and extended and felt like it was on fire and was extremely painful. 4 hrs later she started vomiting along with diarrhea. The vomiting continued non stop along with the pain and burning in her stomach and back. On 31Mar2021 morning the pain settled into the right lower stomach and became so painful she could barely stand. She went to the ER and was diagnosed with appendicitis. She had surgery that night and found my appendix had ruptured. The OR nurse told he she was the 2nd lady that day who's appendix had ruptured after having their First COVID vaccine and there had been others. She believed this was absolutely the direct result of the vaccine. She queried why were we not warned of this violent side effect of the vaccine. The outcome of events was recovering.
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| 60 | 2021-04-18 | vomiting |
left side headache, left eye pain, severe vomiting, full body pain, neck pain, chills as of Sunday s...
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left side headache, left eye pain, severe vomiting, full body pain, neck pain, chills as of Sunday some had subsided but not all. tylenol of no use!
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| 60 | 2021-04-20 | gastrointestinal disorder |
her MS started to flare; I have a lot of numbness and tingling in my left side; it's still a little ...
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her MS started to flare; I have a lot of numbness and tingling in my left side; it's still a little tingling; I have a lot of numbness and tingling in my left side; it's still a little tingling; I had 3 days of sheer misery I couldn't use my left side as I am left handed; it made it kind of difficult; I couldn't hold anything in it, if I wanted to put my hand back; I could not even grab my head up to put it off; I have been not feeling that good; shot I went to home I had gastro intestinal problems; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in arm left (reported as "Left shoulder") on 31Mar2021, at the age of 60-year-old (Batch/Lot number was not reported, it was reported that "it says Pfizer and then 8733") as single dose for covid-19 immunisation. Medical history included multiple sclerosis (MS) and she had the GA (gallbladder atony) thing it was awful she mean anything she ate or drank, right to the toilet. Concomitant medications included ibuprofen (ADVIL) taken for an unspecified indication, start and stop date were not reported and Vitamins. Consumer stated, she had the COVID-19 shot last Wednesday 31Mar2021 and she have MS so what it happens was she have got the shot she went to home she had gastro intestinal problems she had she could not get off the toilet for a while and then her MS started to flare, So she have a lot of numbness and tingling in her left side and it's still a little tingling but she had 3 days of sheer misery. She couldn't use her left side as she was left handed so it made it kind of difficult and she live alone. The reporter wanted to know that it was as potential side effects, she was just glad they didn't go full blown affect because they are miserable. When paraphrased the above concern, Consumer stated, No she was starting to get a lot better because she would be really going to say it if it didn't come, because she was not going to stand it but 3 days she couldn't use it at all, she mean she couldn't hold anything in it, if she wanted to put her hand back and probably feel she could not because she was not she could not hold anything she could not even grab her head up to put it off, as she said she had the GA thing it was awful she mean anything she ate or drank, right to the toilet. Consumer stated, No she haven't talked to anybody like any she have been not feeling that good, the first thing she had blown up in because when she had MS it starts to flare she don't she actually want to do is laid down and sleep. For treatment, consumer stated, no treatment, she stayed home, she just rested that's it, it's like her left side is affected her left leg was affected and her arm is affected all the left side is numb and tingly, so she don't like to do anything she don't like to walk anywhere, it's not good. Consumer stated, she just wanted to let us know in case anyone called us with and MS. Date for second shot of COVID-19 Vaccine is "21Apr2021." The outcome of the event "tingling" was recovering; of the other events was unknown. Information about lot/batch number has been requested.
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| 60 | 2021-04-23 | nausea |
Chills; body aches; fever; nausea; This is a spontaneous report from a contactable consumer (patient...
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Chills; body aches; fever; nausea; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration in the left arm on 11Feb2021 at 08:45 AM (at the age of 60-year-old) as a single dose for COVID-19 immunization at Workplace clinic. Medical history included allergies to medications, food, or other products was Sulfa drugs. Prior to the vaccination, the patient was diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications received within 2 weeks of vaccination included citalopram at 20 mg. Patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) for Covid-19 immunization. On 12Feb2021 at 12:00 AM, on the second day, the patient experienced chills, body aches, nausea and fever. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the chills, body aches, nausea and fever were recovering. No follow-up attempts are Possible. No further information can be obtained.
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| 60 | 2021-04-24 | vomiting, diarrhea, nausea |
possible hearing loss; episodes of elevated tinnitus (pre-existing); vertigo; dizzy; hands felt like...
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possible hearing loss; episodes of elevated tinnitus (pre-existing); vertigo; dizzy; hands felt like vibrating; nauseous; threw up; diarrhea; chills; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 60 years of age), dose 2 via an unspecified route of administration, administered in arm left on 05Apr2021 13:00 (Batch/Lot Number: EP7533) as a single dose for COVID-19 immunisation. Medical history included tinnitus and penicillin allergy, both from an unknown date and unknown if ongoing. Concomitant medications included ciclosporin (RESTASIS) and vitamin d nos (VITAMIN D NOS), both taken for an unspecified indication, start and stop date were not reported. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE (lot number: EL9629) (at 60 years of age), dose 1 in the left arm on 08Mar2021 13:00 for COVID-19 immunisation. The patient was not pregnant. The patient did not receive any other vaccine in four weeks prior to covid vaccine. The patient had no covid prior to vaccination. The patient has not been covid tested post vaccination. The patient experienced repeated night time episodes of elevated tinnitus (pre-existing), possible hearing loss, vertigo, dizzy, hands felt like vibrating, nauseous, threw up, diarrhea, and chills, all on 05Apr2021 14:00 PM with outcome of recovered/resolved with Sequel. The events resulted to Emergency room/department or urgent care. No treatment received for the events.
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| 60 | 2021-04-26 | nausea, vomiting |
her whole left side, including the left side of her face went numb; lost focus; throw up; Emotional ...
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her whole left side, including the left side of her face went numb; lost focus; throw up; Emotional instability; head hurts; nauseous; Disorientated; Dizzy; Slurred speech; Balance impaired; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2, dose 1 via an unspecified route of administration, administered in left arm on 30Mar2021 17:30 (Lot Number: EW0150; Expiration Date: 31Jul2021) as single dose for COVID-19 immunisation. Medical history included depression from 2005 to an unknown date, blood pressure high in 2020 and unknown if ongoing, and high cholesterol in 2020 and unknown if ongoing; stated she was diagnosed with high blood pressure and high cholesterol about a year ago and was on low doses of blood pressure medication and cholesterol medication. There were no concomitant medications. The patient has no prior vaccinations (within 4 weeks). The patient experienced her whole left side, including the left side of her face went numb on 31Mar2021 with outcome of recovering, lost focus on 11Apr2021 with outcome of not recovered, head hurts on 31Mar2021 with outcome of not recovered, nauseous on 31Mar2021 with outcome of not recovered, disorientated on 31Mar2021 with outcome of unknown, dizzy on 31Mar2021 with outcome of not recovered, slurred speech on 31Mar2021 with outcome of recovered in Apr2021, balance impaired on 31Mar2021 with outcome of not recovered, throw up on 10Apr2021 with outcome of recovered on 10Apr2021, emotional instability on 31Mar2021 with outcome of not recovered. The patient received her 1st dose of the Pfizer COVID19 Vaccine on 30Mar2021 and experienced a bucket load of side effects listed with the vaccine. She mentioned that she has lost focus, her head hurts, and so nauseous. She mentioned that half of her face is numb and that she was hospitalized for 24 hours because the doctors thought she had a stroke. She mentioned she has never had a reaction to anything and the doctors told her that this was related to the vaccine. She is asking how long does this side effect last, if the 2nd dose would have more severe side effects than the first, and could she receive her 2nd dose scheduled this Saturday after experiencing this side effects. She mentioned that her doctors recommended that she get vaccinated. She is in distress as she mentioned that this side effects have affected her life and her job. Further clarified, on 31Mar2021 she was disoriented, dizzy, nauseous, and had a massive headache. She said her symptoms were all on the list of possible COVID-19 Vaccine side effects. She said then her (whole) left side, including the left side of her face went numb. She said she called the nurse on the help line, and the nurse told her to call #. She said she didn't call # because she thought it wasn't necessary. She said she went to urgent care. She clarified at the urgent care they flipped out and wheeled her into a back room and hooked her up to a heart monitor, and brain monitor. She said that was around 5:00PM-6:00PM on 31Mar2021. She said she was taken by ambulance from the urgent care to the hospital emergency room. She said she stayed in the hospital overnight. She said she also had slurred speech, couldn't balance, and couldn't track (clarified as focus). She said it was awful. She said they thought she had a stroke because the left side of her face, and her whole left side were numb. She said if she tried to smile, one side of her face didn't work like other side of her face. She said when she was at the hospital, the hospital did all kinds of tests on her. She said she was told she didn't have a stroke, and her symptoms had to be a side effect of the COVID-19 Vaccine shot. She said the doctors at the hospital told her to "tough it out", and wait until her symptoms were done. She said the numbness was gradually going away on the left side of her body. She said the left side of her face was partially numb, and she had parts of left arm that were still numb. She said Thursday, 08Apr2021, was the first day she felt good. She said she was able to focus, and work. She said she felt she had a steady focus, and was not losing her mind. Friday morning (09Apr2021) was "iffy", but she felt she had improved some during the day. She said by Friday night (09Apr2021), she was dizzy, had a headache, was nauseous, and her balance was off. She said on Saturday morning (10Apr2021), she was nauseous, and started throwing up. She said she continued to throw up until Saturday night (10Apr2021). She said she was still nauseous on Saturday night, but was able to have soda crackers. She said she felt like she was standing at a cliff, because she was still nauseous, but not throwing up. She said Sunday morning (11Apr2021) she was not great. She clarified she was still nauseous, had a headache, was constantly dizzy, and lightheaded. She said she didn't throw up, but her focus kept coming and going. She said she felt worse as Sunday night (11Apr2021) came on. She said today (12Apr2021), she was so nauseous, her head hurts, she was dizzy, and couldn't track (focus) well. She clarified she never had a fever with her other symptoms. Caller asked what the hell was going on, and why was it still happening, and how long were her symptoms going to last. She said she was scheduled to get her second COVID-19 Vaccine shot on Saturday (17Apr2021). Caller asked should she get the second COVID-19 Vaccine shot. Reported also had emotional instability from day one (31Mar2021) of her symptoms. Reported she had been resting for a half hour at a time. She said she would feel better for a period of time after resting, so the resting helped. She said she also took Ibuprofen and Tylenol (clarified as generic (place name withheld) Acetaminophen 500mg). She said the Ibuprofen and Acetaminophen helped to keep her headache in the background. Hospital Treatment: She said while she was at the hospital, she was given Aspirin and Tylenol because of her headache. She said the doctors at the hospital didn't change her home medications. The patient underwent lab tests and procedures which included blood test: normal on 01Apr2021, head CT (computerised tomogram): normal on 31Mar2021, echocardiogram: normal on 01Apr2021, tests: unknown results on an unspecified date (the hospital did all kinds of tests on her), MRI brain (magnetic resonance imaging): normal on 31Mar2021, carotid artery ultrasound: normal on 01Apr2021. Therapeutic measures were taken as a result of head hurts (headache). Reporter seriousness for her whole left side, including the left side of her face went numb: hospitalization from 31Mar2021 to 01Apr2021, required a visit to Emergency Room and Physician Office/Urgent Care.
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| 60 | 2021-04-26 | nausea |
I had all this pain at the injection side; tired; headache; chill; throat pain; fever; nausea; swoll...
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I had all this pain at the injection side; tired; headache; chill; throat pain; fever; nausea; swollen lymph nodes; This is a spontaneous report from a contactable consumer (Patient) reported for herself. A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/expiration date: unknown) via an unspecified route of administration on 23Feb2021 (at age of 60 years) at single dose for COVID-19 immunization. Patient relevant medical history included chronic obstructive pulmonary disease (COPD). Patient concomitant medications were not reported. After receiving covid-19 vaccine patient started running really high temperature and pain at the vaccination side, really tired, headache, chill, throat pain, fever, nausea, Patient said swollen lymph nodes, throat has been sore on unspecified date. Patient stated that run temperature but took Tylenol and it took it down it was high, but I still have the soreness. Patient also mentioned having COVID 19 infection months ago. Treatment received for events was unknown. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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| 60 | 2021-04-26 | nausea |
This is a spontaneous report from a contactable consumer who reported for herself, a 60-year-old fem...
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This is a spontaneous report from a contactable consumer who reported for herself, a 60-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ew0158), via an unspecified route of administration, administered in right arm on 08Apr2021 at 16:00 (at the age of 60 years old) at a single dose for COVID-19 immunization. Medical history included overactive immune system, valley fever, Lyme disease, and known allergies to penicillin and morphine. The patient was not pregnant at the time of vaccination. Patient had no COVID prior to vaccination and was not COVID tested post vaccination. Concomitant medications included supplements. Patient had no other vaccines in four weeks. On 09Apr2021, patient experienced very sore arm and vertigo. Then 24 hours later, on 10Apr2021, a feeling of dizziness/severe dizziness and nausea that comes and goes - which has been going on for days. It felt like patient was about to pass out. The patient was not able to stand, she can't stand up. Her body suddenly got hot then followed by feeling chills, but no fever. She was feeling so odd and severe brain fog. The patient was feeling so ill. She tried to call Pfizer because she wanted to know how long this will be going on. She didn't know whether to take the second dose. She felt so sick she couldn't drive or work. The events resulted in doctor or other healthcare professional office/clinic visit. Unspecified treatment was received for the events vertigo, dizziness, nausea, "Not able to stand/can't stand up" and "feeling so ill/feel so sick". The outcome of the events was not recovered.
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| 60 | 2021-04-26 | vomiting |
This is a spontaneous report from a contactable consumer. A 60-year-old female patient received bnt1...
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This is a spontaneous report from a contactable consumer. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 27Mar2021 12:30 (at the age of 60-years-old) (Batch/Lot Number: ER-8730) as SINGLE DOSE for covid-19 immunization. Medical history included Hypothyroid, High Blood Pressure. Concomitant medications included levothyroxine sodium (SYNTHROID); losartan potassium (LOSARTIN); amlodipine; hydrochlorothiazide; all taken for unspecified indications, start and stop dates were not reported. On 27Mar2021 13:30, the patient experienced Bleeding at the site, fainting and vomiting while passed out for 5 minutes. The patient believes the injection was too high and she hit a vein. It was further reported that the patient is not a squeamish person and have never had reactions to any shots or blood draws in the past. The event fainting and passed out was assessed as serious (medically significant). Therapeutic measures were taken as a result of bleeding at the site. The patient did not receive treatment for the events fainting, passed out, and vomiting. The outcome of the events was recovered.
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| 60 | 2021-04-30 | diarrhea, nausea |
anaphylactic reaction; anti kell antibodies in her blood; nausea; her left and her right hips, both,...
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anaphylactic reaction; anti kell antibodies in her blood; nausea; her left and her right hips, both, had severe pain/her right knee joint is in severe pain; she could barely walk and she couldn't bend at all; really weak; had leg aches; she couldn't stay awake/she couldn't sleep again; diarrhea; severe pain at the back of her neck with a headache; severe pain at the back of her neck with a headache; had extreme fatigue; lightheadedness; upper back pain; bloody nose; she couldn't see out of her left eye for about 2 hours; she couldn't breathe; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8731), via an unspecified route of administration, administered in Arm Right on 08Apr2021 10:41 as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 60 years). Medical history included ongoing chronic obstructive pulmonary disease, ongoing chronic kidney disease and Positive ANA. The patient's concomitant medications were not reported. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727) on 18Mar2021 for covid-19 immunisation and experienced First dose: a little bit of soreness and swelling all on the site. The patient stated that during her second dose last Thursday on 08Apr2021, she had an anaphylactic reaction and she couldn't breathe and long story short she had to go to the emergency room and she was given all kinds of epi shots and treatment and stuff and eventually she had to be kept in the ICU unit. She is not sure why she had such a severe reaction. She wanted to report that since then she has kept track every day on how she has been and she actually thought yesterday was the first day that she had felt better. She had extreme fatigue, lightheadedness, upper back pain and even a bloody nose on 10Apr2021 and also she couldn't see out of her left eye for about 2 hours. Then on 11Apr2021, she had severe pain at the back of her neck with a headache that lasted about 20 minutes and she couldn't move her neck. She had diarrhea and the only temperature she had was on 12Apr2021, it was only 99.5 degrees Fahrenheit, which isn't bad, but she had really bad diarrhea on 12Apr2021 and she took Imodium. She had a headache and slight breathing difficulties and things like that. On 13Apr2021 she had a headache, was really weak, had leg aches, fatigue that was really bad and she couldn't stay awake and her temperature that day was 98.7 degrees Fahrenheit which is normal. Then yesterday, 15Apr2021, she thought she was over all the things and that she was feeling better from the fatigue, nausea (occurred on an unspecified date), lightheadedness but she couldn't sleep again. She didn't sleep since Wednesday morning until last night finally and she only slept for an hour since Wednesday morning. She woke up on 15Apr2021 and had no symptoms except her left and her right hips, both, had severe pain and she could barely walk and she couldn't bend at all. All she could do it take Tylenol and she used a heating pad and the pain was excruciating. She went to bed last night and she did sleep for maybe a total of 2 hours and when she woke up this morning her left hip seemed to be a little better but her right hip is still in severe pain and now her right knee joint is in severe pain too. Other than that, she has no other symptoms just the joint pain. She didn't know it would go on for this long, it has been over a week now and she just wanted to let us know about this. The patient was hospitalized for the event anaphylactic reaction from 08Apr2021 to 08Apr2021. The patient underwent lab tests and procedures which included Blood typing: anti kell antibodies (doctor randomly decided to do a blood typing and they found anti kell antibodies in her blood) on an unspecified date, temperature: 99.5 degrees fahrenheit on 12Apr2021, temperature: 98.7 degrees fahrenheit on 13Apr2021. Therapeutic measures were taken as a result of anaphylactic reaction, dyspnoea, diarrhea and arthralgia. Outcome of the event anaphylactic reaction was recovered with sequelae on 09Apr2021 while outcome of the events nausea, dyspnea, arthralgia, sleep disorder and movement disorder was unknown. Outcome of the event vision impairment was recovered on 10Apr2021 while outcome of the event neck pain was recovered on 11Apr2021. Outcome of the remaining events was recovered on 15Apr2021.
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| 60 | 2021-04-30 | diarrhea, vomiting, nausea |
DVT blood clot; ankle was still swollen and uncomfortable; ankle was still swollen and uncomfortable...
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DVT blood clot; ankle was still swollen and uncomfortable; ankle was still swollen and uncomfortable/discomfort; nights were the worst for the pain; pulse ox was low; d-dimer was very high; fainted; Fracture of ankle/two fractures on her ankle; severely nauseous; Vomiting; Diarrhea; deathly sick; This is a spontaneous report from a contactable consumer, reporting for herself. A 60-year-old female patient received the first dose of the bnt162b2 (BNT162B2; Lot Number: ER8727), via an unspecified route of administration in the left arm on 26Mar2021 at 14:00 at a single dose for covid-19 immunisation. Medical history included osteoporosis at least 10 years, terrible nausea, mild case of covid from Nov2020 to an unknown date. There were no concomitant medications. The patient previously took alendronate from 2008 to an unknown date and experienced very sick, nausea, diarrhoea and zoledronic acid (RECLAST) from Dec2017 and experienced nausea and vomiting. On 27Mar2021 at 2:00, the patient experienced deathly sick, fainted, fracture of ankle/two fractures on her ankle, severely nauseous, vomiting, and diarrhea. On an unknown date, the patient experienced dvt blood clot, ankle was still swollen and uncomfortable/discomfort, the nights are the worst for the pain, pulse ox was low, and d-dimer was very high. The event, deathly sick, was life-threatening. The clinical course was as follows: the patient had the first dose of the vaccine on 26Mar2021 at 14:00 in the afternoon in her left arm. Twelve hours after the first dose, later in the night about 02:00 AM she woke up deathly sick; and severely nauseous. She remembered she was going to the bathroom then she must have fainted because they were taking her to the hospital. She went to the ER and they found she had a fractured ankle. She was not admitted to the hospital. She was in the ER from about 03:00 AM to noon the next day. There must have been something in there; she knew there must be something in the vaccine because of her reaction. Adds a few years ago, something like this happened before. She had osteoporosis and had similar reactions with other products she had tried for osteoporosis; she had terrible nausea. The other products she tried included: in 2008 she took alendronate, it made her very sick but not as severe as this time, she never fainted. She had nausea and diarrhea. Then in Dec2017 she had zoledronic acid. She went for an infusion at the hospital then went shopping, and was fine until the early morning, when she woke up with nausea and vomiting. In the ambulance, they gave her ondasetron (ZOFRAN) for the nausea so the vomiting stopped. With regard to her ankle, first they thought it was a DVT blood clot. They did the xray and saw actually two fractures on her ankle but she does not need surgery. She saw the orthopedic doctor the other day and he said her ankle was healing but she still will have no weight bearing for 6 weeks and she was in a boot. Adds her ankle was still swollen and uncomfortable. She hated to take medications and they gave her oxy but she didn't want to take it. She was taking ibuprofen but that messed up her stomach. The nights are the worst for the pain and discomfort. Doctor at the hospital and primary care agreed she should not have the second dose. She did have mild case of COVID in Nov2020 and they are hoping she had antibodies from the infection and the first dose. Her primary care doctor was reviewing the blood work she had done at the hospital and told her they were surprised the hospital didn't admit her for observation because her pulse ox was low and there was another test that she was questioning because the d-dimer was very high. They did a chest x ray with unknown results. The doctor was questioning why they didn't do something else to rule out a blood clot. Therapeutic measures were taken as a result of the events, deathly sick, DVT blood clot, fainted, fracture of ankle/two fractures on her ankle, severely nauseous, vomiting, diarrhea, ankle was still swollen and uncomfortable/discomfort, nights were the worst for the pain, pulse ox was low, and d-dimer was very high. The clinical outcome of the events, deathly sick, fainted, severely nauseous, vomiting, diarrhea, was recovered on 27Mar2021. The clinical outcome of the events, DVT blood clot and nights were the worst for the pain, pulse ox was low, and d-dimer was very high, was unknown. The clinical outcome of the event, fracture of ankle/two fractures on her ankle, was recovering. The clinical outcome of the event, ankle was still swollen and uncomfortable/discomfort, was not recovered. No follow-up attempts are needed. No further information is expected.
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| 60 | 2021-04-30 | difficulty swallowing |
Caller states the patient had an anaphylactic reaction twice that caused her to go to the emergency ...
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Caller states the patient had an anaphylactic reaction twice that caused her to go to the emergency room; couldn't swallow; right side of the patient's face swelled up and her lips were numb; right side of the patient's face swelled up and her lips were numb; face numb; hands itching; tongue had swelled up; voice was scratchy; This is a spontaneous report from a contactable consumer, Reporter's sister via Pfizer-sponsored. A 60-year-old female patient received the second dose of BNT162b2 (Pfizer-Biontech COVID-19 vaccine, Solution for injection, Lot number: unknown, NDC number: Unknown, Ex-piry Date: Unknown) via an unspecified route of administration on 01Mar2021 on an unknown ana-tomical location as a single dose for COVID-19 immunization. Caller provided that her sister got the vaccine for COVID Prevention and because the patient has a handicapped, bedridden husband who has MS and is immune compromised, and it was to help prevent him from getting sick. Caller reported that the patient received the product during the daytime, all the women at the patient's job, which was home health payroll, everyone left to get the vaccine during work hours, like in the AM at around lunch time. Patient's medical history and concomitant medications were unknown. Patient has not received any prior vaccinations within 4 weeks. Patient had no other vaccines on the same day as the suspect product. Patient received first dose of BNT162b2 (Pfizer-Biontech COVID-19 vaccine, Solution for injection, Lot number: unknown, NDC number: Unknown, Expiry Date: Unknown) on 08Feb2021 with no reaction. She worked for a health agency and the whole office went and got it. Caller provided that her sister had a reaction the first time, on 03Apr2021, where her sister woke up with itching started in her hands and ended up migrating to her whole body. By morning patient's tongue had swelled up, couldn't swallow and her voice was scratchy, like the caller couldn't understand her sister's speech well. Caller provided that her sister went to the ER and said there was a whole team giving her urgent care, medication, and such. Caller reported that her sister said the ER didn't find anything in her bloodwork, and the caller did not think the patient was being treated for any other medical conditions, and caller did not think her sister is on any medications, but caller said to not quote her on that. Caller knew her sister had a weight problem, but she did not know if her sister needed blood pressure medication or anything. Caller reported her sister said that the bloodwork from the ER did not find any-thing, and the patient was not admitted to the hospital. Caller reported that at this time, her sister's adverse events were no longer ongoing as her sister was given Steroids, like Prednisone, Benadryl and Famotidine, and she took those products as recommended by the doctor. Caller did not know the end date of her sister's events; all she knew was that the reaction initially started on 03Apr2021. Caller stated that her sister was allergic to nothing, and she has never had incidences of itching like that, where the itching was so bad that she was stripping down and the patient's daughter was patting the patient down with witch hazel. Caller stated that ER released the patient and gave her some medications and such. Caller stated that a day or so later, there was a second round of reaction: the right side of the patient's face swelled up and numb and her lips were numb, like when people have a dental procedure. Lips were numb for a while. Upon completion of the medications she was given, the reactions stopped. Patient regularly saw the family doctor. She would go back to see her Doctor on Thursday. HCP Information was unknown to the caller, but caller stated that her sister had been recommended to go to her PCP and get an Epi Pen. Caller stated that knock on wood, so far, her sister was holding her own, and it had not happened again. Caller stated that she was reporting the data that her sister gave to her after having the Pfizer vaccination. Caller stated the patient had an anaphylactic reaction twice that caused her to go to the emergency room. No relevant tests were done. Caller stated that she had the dates that she had her shots and where she had her shot at. Caller stated somebody called and reported it already. Caller stated she was trying to press three but never could figure out which prompts was. Caller stated they said if she called this number, they would tell her at the medical information department if this occurrence has happened to other people, like statistics. Caller stated they tried to call this number, but it was too long of a wait. Caller stated that she did not have the vaccination card, she never asked for them. Caller does not have card with her at time of call for LOT, NDC, Expiry date. Caller stated that she knew that all the COVID vaccines are just in the Emergency Use Authorization stage and in clinical trials, but caller really thought that all manufacturers should be advertising that they would like feedback from patients. Caller has not heard anything from any of the manufacturers saying that people are welcome to reach out and report side effects. Caller states that she only knew to call because she used to be a Home Health Worker, and she thought this is an important data. Caller has never seen on any of her 19 TV channels about calling to report. Caller stated that the girl who first answered her call, read a clinical data sheet about joint pain being seen in 23% of patient's and not knowing a percentage for anaphylactic reactions, caller was wondering if this was true. Caller verified that she just wanted to ask basically that patient was not alone, if other people might have had that happen too. Caller stated that she tried to call, and it would ask another question and it would say press 1 or 2, then it would ask other questions and it would say press 1 or 2, she never got an option 3. Caller asked: how much percentage, has anyone reported this side effects weeks after the second dose. Caller was wondering if this reaction could have been from the vaccine. Investigation Assessment: No. The outcome of the events were unknown. Information on the lot/batch number has been requested.
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| 60 | 2021-05-04 | nausea |
blood pressure (BP) went over 269/149, it made my blood pressure go up.; left side of middle back ha...
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blood pressure (BP) went over 269/149, it made my blood pressure go up.; left side of middle back had some excruciating pain; Nauseous; I had a major body ache; it started hurting the minute she put it in my arm/Excruciating pain; pain in the neck down the arm; I had a major body ache; it started hurting the minute she put it in my arm/Excruciating pain; pain in the neck down the arm; I had a major body ache; it started hurting the minute she put it in my arm/Excruciating pain; pain in the neck down the arm; I got a mark on my arm, my arm started swelling; This is a spontaneous report from a contactable consumer reporting for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EW0164/expiration date: 30Jun2021), via an unspecified route of administration, on 16Mar2021 (at the age of 60 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN6208/expiration date: not provided), via an unspecified route of administration, on 16Mar2021 (at the age of 60 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION and experienced a headache. Relevant ongoing medical history included Diabetes Type II from about 5 years ago in 2016, fibromyalgia diagnosed about 6 years ago in 2015, and high blood pressure. Concomitant medication included gabapentin from an unspecified date at 600mg 3x/day for fibromyalgia, empagliflozin (JARDIANCE) from an unspecified date at 10mg 1x/day for Diabetes Type II, clonidine from an unspecified date at 30 mg, 2x/day for high blood pressure and labetalol from an unspecified date at 200 mg, 2x/day for high blood pressure. On an unspecified date in Mar2021, the patient experienced her blood pressure (BP) went over 269/149, it made my blood pressure go up, which required hospitalization overnight. Also on an unspecified date in Mar2021, the patient experienced a mark on her arm, and her arm started swelling. On 16Mar2021, the patient experienced major body ache, described as it started hurting the minute she put it in her arm, excruciating pain and pain in the neck down the arm, and she was nauseous. She described that she couldn't get out of the bed because of so much body pain. On 21Mar2021, the patient experienced her left side of middle back had some excruciating pain. The clinical course was as follows: I had a major body ache with the second vaccine. I did not have any problem except the headache with the first one but I took second one on this past Friday, I got very nauseous, it started hurting the minute she put it in my arm, which is on the left side. I got a mark on my arm, my arm started swelling. Saturday morning I couldn't get out of the bed because of so much body pain, Sunday my left side my middle back I had some excruciating pain I rushed to the doctor to the ER, my BP went over 269/149 and they had to give me pain medicine and BP medicine to reduce the blood pressure. I made it to the doctor and I'm getting medicine for the pain. I woke up in the morning there's pain in the neck down the arm and it's aching, the side I got the shot, the side is hurting, excruciating pain in my arm. I had to go to the ER straight to my doctor's office, they wouldn't let me drive or anything straight to the ER where they administered 2 doses of pain medicine and 3 doses of blood pressure, the pain was so intensive it made my blood pressure go up, the doctor said all of this was coming from the vaccine." Relevant lab data on an unspecified date in Mar2019 included blood pressure 269/149. The patient received treatment for the events blood pressure high, body pain, neck pain, pain in arm, and back pain. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021446955 same reporter/patient/drug, different event in separate dose
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| 60 | 2021-05-06 | retching, diarrhea, difficulty swallowing, nausea, vomiting |
Itching on her hands and her feet; Chills; Clammy; Sensitivity to light; inflammation; Under her eye...
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Itching on her hands and her feet; Chills; Clammy; Sensitivity to light; inflammation; Under her eyes it is swollen; She was having severe diarrhea; having severe dry heaves; vomiting bile; It had dehydrated her/lead to dehydration; Her throat closing up and it being sore from vomiting and dry heaving; couldn't swallow to get any fluids in; Her throat closing up and it being sore from vomiting and dry heaving; she was struggling with having a dry mouth; puffiness; Headache; severe muscles aches/Muscles pain; feeling nauseous; Was a little warm on her arms/ it was warm to the touch; it just looked like a bee sting and it wasn't super sore; sensitive to the touch; It had big red spots; had a little tiredness; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 16Apr2021 at 10:00 (at age of 60 years old, Lot Number: EW0ISO) as single dose for covid-19 immunization. Medical history included she had lupus, sjogren's syndrome. The patient's concomitant medications not reported. The patient previously took Pneumonia Vaccine on 04Mar2021 (Anatomical Location: Left arm); took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 26Mar2021 at 10:00 (at age of 60 years old, Lot Number: the lot number starts with ER something and then it ends with a 3) as single dose for covid-19 immunization; took azathioprine for lupus and had allergic reaction; took belimumab (BENLYSTA), subcutaneous from an unspecified date (Lot Number: PV7G; Expiration Date: Jun2023, NDC: 49401-088-01, Number on the side: 0147098) to an unspecified date, self injection once a week for lupus. She gets it through the VA and it is subcutaneous use and the manufacturer is company. she was immunocompromise, she had lupus, so she was off of her medication (BENLYSTA) for a month per the CDC guidelines. She wanted to let Pfizer know that as well. For her first COVID vaccine she was originally scheduled to go 6 to 7 days after she had her pneumonia shot and they told her that she would have to wait 2 weeks before having her COVID shot and she did. Other than that she had followed the guidelines and she had been able to take her regular medications but she had to stop her Benlysta because of her immune system and everything. She had been following through on what the CDC has said. Patient stated that she just did a follow up with her doctor because of what happened after her second Pfizer COVID vaccine and her doctor recommended her to let Pfizer know about the side effects that she was having. On Friday 16Apr2021 she had her shot at 10 AM and it was no big deal, it was a little warm on her arms. She stated that it just looked like a bee sting and it wasn't super sore, it was warm to the touch and sensitive to the touch. It had big red spots and there has really been no change since it began. It looks about the size of a bee sting and it was still there. She had a little tiredness and she was not hungry but when she woke up at 06:40 the next morning (17Apr2021) on Saturday she was having severe dry heaves and vomiting bile and she could not get it under control. It had dehydrated her and she was having severe muscles aches. She had the severe dry heaves and the vomiting that lead to dehydration and then she went to the emergency room and she got replenished and they had given her something for feeling nauseous and eventually she was released 3 to 4 hours later. They gave her pills as well so she was doing well now and she hasn't done anything since she went to the emergency room with the vomiting and feeling nauseous. She went there about 1030 to 1040. Before she went she couldn't stop and she told herself that if it didn't stop on the 5th time then she was going to go to the emergency room and it got really bad so she had to call 911 to come and get her. Then she was having severe diarrhea on Sunday (18Apr2021) and the only way she could stop that was for her husband to pick up antidiarrheal pills. That only went away because of the medicine from the pharmacy. She had the over the counter medicine and she took Imodium. She hasn't been eating a lot so she hasn't had a bowel movement since she took that medication. When she had diarrhea there was no substance, it was very watery. And now today (unspecified date) she was having another reaction that she was seeing and it was just itching on her hands and her feet. She had been continuing to take the Benadryl and something that they gave her in the emergency room and she had taken Tylenol for the little headache that she has had. She had a slight headache and she was still taking Tylenol like they had recommended. This began the same time as she was vomiting on 17Apr2021 when she was going through all of that she had the slight headache. But her biggest concern was during this time when initially on Saturday (17Apr2021), her throat closing up and it being sore from vomiting and dry heaving, she was having the dry heaves her airway closed shut and she couldn't swallow to get any fluids in. Her concern was that the back of her throat was killing her and it was totally closed up so she had to go to the emergency room. She had recognized this because in the past she has had a medication where she had an allergic reaction (she thinks it is the medication that they gave her for lupus because she has been on several different things. She thinks azathioprine but she can't recall exactly but she thinks that might of been the one that did it to her) and it had closed her esophagus up the same way like this. This time it got worse to where she couldn't even swallow water no less a pill. This was on 17Apr2021. When she went to the emergency room they gave her the hydrocortisone to take it down and she actually had felt better while she was waiting for the saline drop. She was able to swallow when her airway was opened again by the time they treated it with the hydrocortisone. Around 16:00 she was better when she left the emergency room that same day 17Apr2021. She doesn't really have a sore throat, it is pretty fine. It seems to be okay she thinks that once the dry heaves and all that stopped it helped to relax that. She was a little raspy from the whole thing and she was struggling with having a dry mouth but that even had been resolved as far as her throat. She had no other reactions than what she explain but she also had a lot of muscles pain but that was to be excepted because it says that on all that she has read. She had had all of the reactions listed except for fever. She had had chills and then when clammy and then was clammy and had chills. She had all of those side effects listed on the sheet and when she went on Saturday following her vaccine to the emergency room most of the side effects were treated in emergency room. They gave her Pepcid, hydrocortisone through her IV and gave her Zofran for the vomiting and they said to keep taking acetaminophen. They gave her cetirizine for allergy or the itching or whatever and they also gave her famotidine which she thinks is Pepcid. Since being off the lupus drug she was getting her symptoms again such as sensitivity to light, inflammation and the dry heaves didn't help so under her eyes it was swollen and she just takes it as it was because she was not on her medication and she had something else injected inside of her. Also, she had Sjogren's disease too so her eyes were already drier than normal and she had had puffiness since 17Apr2021 when she was vomiting. She just wanted to make sure that Pfizer got that information because she didn t see that listed. The only side effect she was related was the swollen glands and she has glands in her throat but she wanted to be sure that Pfizer had that data just in case if it could help someone else. Again, she wants to reiterate that with her first dosage she had no problems. She couldn t even see the mark and all of this is stemming from the second dose of the COVID vaccine. The outcome of the events "Dry heaves, Bilious vomiting, Dehydration, Her throat closing up and it being sore from vomiting and dry heaving, Unable to swallow, Dry mouth, Nauseous" was recovered on 17Apr2021. The outcome of events "Feeling of warmth, Vaccination site pain, Hyperaesthesia, Vaccination site erythema, Tiredness" not recovered. The outcome of the event "Headache" was recovering. The outcome of other events was unknown. No follow up attempts are needed. No further information is expected.
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| 60 | 2021-05-07 | nausea |
High fever of 107.5 degree Fahrenheit; Dizziness; Nausea; Headache; Fatigue; Joint and muscle pain; ...
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High fever of 107.5 degree Fahrenheit; Dizziness; Nausea; Headache; Fatigue; Joint and muscle pain; Joint and muscle pain; Blurred vision; Persistent cough; My glands started hurting; My ears hurt specially on the right where the shot was given everything is the worse; Sore throat; Jaw pain; my neck under my chin is swollen and painful; my neck under my chin is swollen and painful; Abscess in my gum and swelling and blisters in my mouth; Abscess in my gum and swelling and blisters in my mouth; Abscess in my gum and swelling and blisters in my mouth; This is a spontaneous report from a contactable consumer(patient). A 60-years-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: EW016) via an unspecified route of administration in right arm on 19Apr2021 at 17:15 as SINGLE DOSE for covid-19 immunization. Patient was 60 years old at the time of vaccination. Medical history included rheumatoid arthritis, COPD, chronic empyema, asthma, chronic bronchitis, gastritis, irritable bowel syndrome, blood pressure high and digestive disorder, all from an unknown date and unknown if ongoing. Concomitant medications included quetiapine fumarate (SEROQUEL), POTASSIUM CHLORIDE, albuterol sulfate (ALBUTEROL), budesonide, formoterol fumarate (SYMBICORT), FLUNISOLIDE, FLUOXETINE, HYDROCHLOROTHIAZIDE, IPRATROPIN, METOPROLOL, MONTELUKAST, PANTOPRAZOLE, FAMOTIDINE and LOSARTAN, all taken on unspecified date for unknown indication. In Apr20, the patient had high fever of 107.5 degree fahrenheit, dizziness, nausea, headache, fatigue, joint and muscle pain, blurred vision, persistent cough, my glands started hurting, my ears hurt specially on the right where the shot was given everything was the worse, sore throat, jaw pain and neck pain, my neck under my chin is swollen and painful, abscess in my gum and swelling and blisters in my mouth. On unspecified date, the patient underwent lab tests and procedures which included body temperature 107.5 degree F, blood test which she does every year and she had a follow up every 6 months. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 60 | 2021-05-13 | difficulty swallowing |
My throat was itchy/my throat felt worse; My throat was itchy in between that half hour my voice sta...
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My throat was itchy/my throat felt worse; My throat was itchy in between that half hour my voice started to change; my throat felt worse; I have wheezing in my lungs; I am allergic to them/ Severe reactions and had to be hospitalized overnight; had problem swallowing a little bit and voice changes after talking; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiration date were not reported), via an unspecified route of administration, administered in Arm Left on 15Mar2021 (Age at Vaccination 60 year), as single dose for covid-19 immunisation. Medical history of the patient included anxiety, depression, nerve pain, ongoing blood pressure (hypertension), change in personality and cardiac disorder. Concomitant medication of the patient included levothyroxine, atorvastatin calcium (cholestat [atorvastatin calcium]), pantoprazole, 1300mg fluconazole (Fluxizol), 81mg aspirin, lubiprostone (Amitiza), alpha lipoic acid, baclofen, linezolid (Zenix [linezolid]), centrum silver, 10mg rosuvastatin calcium (Crestor), 100mg docusate sodium (stool softener), amlodipine and magnesium oxide for blood pressure. Patient was on Benazepril HCTZ for heart, Pristiq for anxiety or depression, citalopram for pain (something to do with pain I can't remember), Effexor for Anxiety, Lexapro, Levaquin, and Sulfa for rashes. Patient got it from her bladder infection. Cyclobenzaprine (I can't remember), Gabapentin, change in personality and nerve pain. Metoprolol for heart. Patient was not taking any of these medications now she got several allergies from them. Patient had a lot of allergies. She was on lot of medications. But it was not what she was taking any these medications on the same, so she was like what was going on. Patient not taking the medication (Unspecified Medication), she was allergic to them, but she was taking other medication. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number, PF12ER6200), via an unspecified route of administration, administered in Arm Left on 22Feb2021 (Age at Vaccination 60 year), as single dose for covid-19 immunisation. On 15Mar2021, the patient had severe reactions and had to be hospitalized overnight. Within mild reaction for 15 minutes and within 40 minutes severe. Patient went to have it done at the hospital they walked her down to the ER they get to give her an epi Pen injection into IV." When again probed for the concern, Patient stated, she had it done at the hospital, they after 15 minutes her throat was itchy they may say another half hour in between that half hour her voice started to change and her throat felt worse they walk her down to the ER her throat was hurting then slowly they gave her Epi Pen and they injected in an IV with steroids. Patient had wheezing in her lungs and she spent the night in hospital for observation. Patient stated that she still had problem swallowing a little bit and voice changes after talking. Patient wanted to know it was like how she supposed to find out what she was allergic. Patient further stated, "Because she want to you know she need an update how was it bad so she want to had to go all this what she was allergic. Event outcome for the events swallowing difficult and for voice alteration it was not recovered and for other events it was unknown. Information about lot/batch number has been requested.
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| 61 | 2020-12-31 | nausea | Body ache, head ache, fever, nausea, liwer leg muscle spams/cramping |
| 61 | 2021-01-01 | nausea, diarrhea |
Approximately 48 hours after receiving vaccine, I developed nausea and extreme diarrhea. This laste...
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Approximately 48 hours after receiving vaccine, I developed nausea and extreme diarrhea. This lasted 2.5 days
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| 61 | 2021-01-03 | diarrhea |
Reports the following symptoms: Left shoulder pain, diarrhea, nasal congestion, sore throat, cough, ...
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Reports the following symptoms: Left shoulder pain, diarrhea, nasal congestion, sore throat, cough, Itching all over body, scalp pain and tenderness. 12/28 Began feeling better, mild cough persists. 1/4: Feels as though she has "bad flu" fever of 101 F.
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| 61 | 2021-01-04 | nausea, vomiting |
Received COVID vaccine, severe headache started 5 minutes after the administration. Jittery, nauseat...
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Received COVID vaccine, severe headache started 5 minutes after the administration. Jittery, nauseated. Continued to have worsening symptoms. Nausea/Vomiting, muscle twitching, severe headache, increased heart rate went to ED on 1/5 at 0100.
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| 61 | 2021-01-04 | nausea |
VACCINE SAT AT 1:30 PM, SUNDAY 9:00 AM FEELING TIRED NAUSEATED, TEMP UP TO101 THROUGH THE DAY, HEADA...
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VACCINE SAT AT 1:30 PM, SUNDAY 9:00 AM FEELING TIRED NAUSEATED, TEMP UP TO101 THROUGH THE DAY, HEADACHE,PAIN IN LEFT ARM AT INJECTION SITE. TEMP SEEMED TO BREAK THAT EVENING 98.0 . MONDAY INJECTION SITE VERY RED AND RAISED, ITCHY, ABOUT 1 TO 1 1/2 INCHES IN SIZE. TODAY TUESDAY SAME SIZE ITCHY NOT RAISED .
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| 61 | 2021-01-04 | nausea | NAUSEA AND HEADACHE |
| 61 | 2021-01-06 | diarrhea | Fever 101.7 Chills, Body Aches, Generalized Weakness, Head Ache, Diarrhea |
| 61 | 2021-01-06 | diarrhea |
Woke up this morning (the day after receiving the vaccine) with chills, fever of 101.9 & diarrhea. C...
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Woke up this morning (the day after receiving the vaccine) with chills, fever of 101.9 & diarrhea. Called my manager at work. Went back to bed. Around 8am took 2 Tylenol extra strength 225 caplets, 500mg each. 3 hours later temp down to 99.2. My normal is 97.6
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| 61 | 2021-01-07 | abdominal pain upper | SEVERE HEADACHE, MILD DIZZINESS, RUNNY NOSE , EAR ACHE, STOMACH ACHE, COLDS,COUGH |
| 61 | 2021-01-07 | decreased appetite, abdominal discomfort | Headache, Myalgia, Arthralgia, decreased appetite, general malaise, some abdominal discomfort |
| 61 | 2021-01-07 | decreased appetite |
Chills; dry cough; no appetite; fatigue; pain at injection site; general malaise; general aches; tem...
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Chills; dry cough; no appetite; fatigue; pain at injection site; general malaise; general aches; temperature 102; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer-BioNTech ;lot number: EK9231) intramuscularly at right arm on 02Jan2021 at 07:45 A.M. at a single dose (dose number: 1) for COVID-19 immunization. Prior to vaccination, the patient was diagnosed with COVID-19 on 07Dec2020. No known allergies (no allergies to medications, food, or other products) and no other medical history. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medications the patient received within 2 weeks of vaccination were none. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced adverse events included chills, temperature 102, general aches, fatigue, pain at injection site, dry cough, general malaise, no appetite. Temperature elevated till 03Jan2021, 6pm. Symptoms similar to what she experienced when diagnosed with covid-19 on 07Dec2020. All events with start date on 02Jan2021 at 06:00 P.M. The events were reported as non-serious. No treatment received for events. The outcome of events was resolving. Since the vaccination, the patient had not been tested for COVID-19.
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| 61 | 2021-01-07 | diarrhea, nausea |
Swollen stiff arm at the site of the injection; Swollen stiff arm at the site of the injection; Naus...
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Swollen stiff arm at the site of the injection; Swollen stiff arm at the site of the injection; Nausea; Diarrhea; shivering; Sweating; Body ache; This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: PFL72TRA9899), intramuscular in left arm, on 31Dec2020 at 07:00, at a single dose, for COVID-19 immunization. The patient's medical history included COVID-19 (diagnosed prior to vaccination). There were no concomitant medications. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a hospital. On 31Dec2020 at 8 PM (also reported as after exactly 12 hours; possibly discrepant), the patient experienced swollen stiff arm at the site of the injection, severe episode of nausea, diarrhea, shivering, sweating, and severe body ache. Treatment received for the adverse events included paracetamol (TYLENOL). The events were considered non-serious. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events.
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| 61 | 2021-01-07 | diarrhea, vomiting, nausea |
Headache; Nausea; Vomiting; Diarrhea; I just ache all over; This is a spontaneous report from a cont...
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Headache; Nausea; Vomiting; Diarrhea; I just ache all over; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; Solution for injection; lot number: EJ1685; expiration date: not known), via an unspecified route of administration on 29Dec2020 at single dose for covid-19 immunisation. Medical history included hypertension. The patient's concomitant medications were not reported. The patient had been feeling fine after her last vaccination when she took it at a hospital on 29Dec2020 until today (01Jan2021), in which she experienced headache, nausea, vomiting, diarrhea, and she just ache all over. The patient stated it was not serious and just wanted to make sure she was not supposed to be doing something. The patient did not receive treatment for these reported events. The outcome of the events was unknown.
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| 61 | 2021-01-07 | difficulty swallowing |
1st day of inj the expected side effect of inj site very sore and fatigue for 25 hours. Day 8 after...
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1st day of inj the expected side effect of inj site very sore and fatigue for 25 hours. Day 8 after receiving the vaccine, at 2 PM started with itching of scalp, arms, legs, rash, and abdominal hives. Proceeded to facial swelling and difficulty swallowing, swelling back of neck. Took 50 mg Benadryl w/ some relief. 630 PM symptoms reoccur, took another 50 mg Benadryl with no relief. Symptoms intensified to severe swelling of back of neck with intense pressure base of skull, radiating to top of head. Proceeded to the ER at 830 PM
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| 61 | 2021-01-07 | nausea, abdominal pain |
Severe chills /tremors 14 hours following the second injection that lasted uncontrollably for one ho...
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Severe chills /tremors 14 hours following the second injection that lasted uncontrollably for one hour, headaches, fatigue, abdominal pain that cleared 1/7 in the afternoon. The nausea was so bad I could not eat. Vomited only one time. I missed one day of work, slept the whole day, and night, too.
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| 61 | 2021-01-07 | nausea | Chills. Nausea. Headache. Body aches. Flushed face |
| 61 | 2021-01-07 | nausea | fever 101, arm soreness, body aches, fatigue, nausea, congestion and dry cough |
| 61 | 2021-01-07 | nausea |
patient reports fasting high blood sugar >200 12+ hours after vaccination - she is diabetic on oral ...
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patient reports fasting high blood sugar >200 12+ hours after vaccination - she is diabetic on oral metformin and has never had elevated blood sugar >140 with fasting; controlled HgA1C at 6.1%; felt dizzy, nauseated, HA and sweaty as if she may pass out - never passed out
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| 61 | 2021-01-08 | nausea |
01/08/21 02:30am on set of headache, 01/08/21 05:15am nausea Headache, called in for work due to thi...
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01/08/21 02:30am on set of headache, 01/08/21 05:15am nausea Headache, called in for work due to this being so bad, 01/08/21 08:54am hip pain/throbbing, took motrin. reported difficulty to bear weight, stayed in bed all day. 01/09/20 01:00pm reports much improved continues with slight pain today, but able to ambulate and function without problems.
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| 61 | 2021-01-09 | nausea | Headache, nausea, body aches, joint pain, fatigue. |
| 61 | 2021-01-10 | abdominal discomfort, diarrhea | Diagnosed with COVID-19, Fatigue, Bodyaches(severe), Myalgia, Fever, Diarrhea, GI Discomfort |
| 61 | 2021-01-10 | abdominal discomfort |
1-24 hours AFTER vaccination: headache, fatigue, body aches, chills, fever (102) 24-48 hours AFTER v...
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1-24 hours AFTER vaccination: headache, fatigue, body aches, chills, fever (102) 24-48 hours AFTER vaccination: headache, fatigue, cough, GI distress, fever (100) 48-72 hours AFTER vaccination: headache, elevated temperature (99.7)
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| 61 | 2021-01-10 | diarrhea |
I had diarrhea, numbness in my face, high blood pressure. 9 days of symptoms. The symptoms started a...
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I had diarrhea, numbness in my face, high blood pressure. 9 days of symptoms. The symptoms started a few days after.
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| 61 | 2021-01-10 | diarrhea |
injection site soreness and swelling, sore are with in 1 hour, lasted 48 hours, diarrhea started 13...
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injection site soreness and swelling, sore are with in 1 hour, lasted 48 hours, diarrhea started 13 hours after injection lasted 72 hours. headache started 12 hours after injection lasted 60 hours tiredness started 4 hours after injection lasted 48 hours I only took tylenol
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| 61 | 2021-01-11 | diarrhea, nausea | Headache, nausea, diarrhea, malaise. Improving. |
| 61 | 2021-01-11 | nausea |
fever; nausea; general feeling of unwell; soreness at site; redness; whole upper arm was swollen aft...
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fever; nausea; general feeling of unwell; soreness at site; redness; whole upper arm was swollen after the injection; This is a spontaneous report from a contactable other HCP (patient, Respiratory Therapist) reported that a 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE , Batch/lot number: EJ1685) via an unspecified route of administration on 21Dec2020 around 6:00 PM in left upper arm at 0.3mL single dose for COVID Prevention. The patient's medical history was covid at the end of Apr/May2020 with shortness of breath, seasonal allergies and allergies to "some anitbiotics." The concomitant medications was reported as none, received no other vaccines on the same day as the COVID vaccine. The patient experienced soreness at site, redness and swelling, fever, nausea, general feeling of unwell 3 days. Patient stated, "I had covid at the end of April/May with shortness of breath. I thought I would have less reaction from the vaccine. I know someone who was out of work for a while week after the vaccine." States that she read that the 2nd dose is supposed to have worse side effects than the first. If she had bad side effects from the 1st dose, will the 2nd be worse? Also asking if the side effects are the immune system reacting or just an allergic reaction. Patient was anxious about getting her second COVID shot on 11Jan2021. Patient stated that she had all the side effects listed, for three days. Patient stated that she didn't mind the side effects at the time, she had fever, soreness at the injection site, nausea, and a general feeling of unwell, but Patient stated that she could not work like that. Patient stated that her question was, statistically she has read that the side effects from the second shot are supposed to be worse than the first shot, but she was wondering, if she had bad side effects from the first shot, will her side effects be worse after the second, or will they maybe be lessened because she already had bad side effects. Patient reported that she did fill out the VSafe significant because she had to work on the third day after her shot, which was Christmas Eve, and work, was so busy and she did not feel well. Patient stated that she does have two days scheduled off work after her next injection, but it is the third day that she was worried about because she does not want to work feeling like that. Patient stated that the arm soreness started that same day (21Dec2020). At first, Patient reported that the arm soreness resolved, but then she states that it is still a little sore to the touch. So Patient confirmed that it is ongoing but improved. Patient reportsed that the fever started the day after the injection, 22Dec2020 and it has resolved. Patient reported that the last day she recorded a fever was on 24Dec2020. Patient stated that she woke up on 24Dec2020 and her temperature was normal, so she went to work and she did not feel so well at work, but they were so busy that she barely noticed, and then when the Patient went home that night, she took her temperature and it was 100 degrees Fahrenheit. Patient reported that the nausea started on 22Dec2020, which was mild at times, but then she got to where she did not want to eat. Patient reported that the nausea has resolved but she was not entirely sure when it resolved because she had been so busy at work on 24Dec2020, and it was hard to tell what she was feeling because she was non-stop busy that day. Patient stated that she was nauseous for a full three days, and she remembered that she did not eat much on the 24th either. So Patient stated that her nausea may have resolved on the third day after her injection, but it is unknown to her what day exactly that it resolved. Patient was also experiencing the general feeling of unwell from 22Dec2020 for a few days, but stated that by 25Dec2020 she felt okay. Patient also included that her left arm was also swollen, like her whole upper arm was swollen after the injection in Dec2020. Patient stated that she also experienced redness, there was a like a red mark that was further down her arm than the injection site in Dec2020. The outcome of soreness at site was recovering. Patient confirmed that both the swelling and redness had resolved in Dec2020.The outcome of fever was recovered on 24Dec2020. The outcome of general feeling of unwell and nausea was recovered on 25Dec2020.
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| 61 | 2021-01-11 | vomiting | developed dizziness and vomiting day of vaccine administration |
| 61 | 2021-01-12 | nausea, diarrhea, abdominal pain |
Initially mild nausea, moderate abdominal cramping for 30 minutes then severe watery diarrhea and mo...
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Initially mild nausea, moderate abdominal cramping for 30 minutes then severe watery diarrhea and moderate to severe abdominal cramping with moderate chills lasting 6 hours. Any fluids taken ran right through me. 4 lb weight loss and muscle cramping from dehydration. 12 hours after symptoms started I was able to take fluids and eat crackers. 24 hours after start felt shaky with mild abdominal soreness but improvement progressed and by 28 hours after start if symptoms felt normal other than I felt like I did 100 sit ups!
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| 61 | 2021-01-12 | nausea |
Nausea, chest pain, difficulty breathing following first dose of Pfizer COVID-19 vaccine 0.3 mL IM i...
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Nausea, chest pain, difficulty breathing following first dose of Pfizer COVID-19 vaccine 0.3 mL IM in right deltoid. Went to outside ED and placed on BiPAP. Given diphenhydramine, epinephrine, and steroid (unknown doses). Prescribed outpatient epinephrine in case of flare of reaction once stabilized.
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| 61 | 2021-01-12 | nausea |
Extreme fatigue, hard chills, fever of 100 for several hours, nausea, generalized weakness. Chills ...
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Extreme fatigue, hard chills, fever of 100 for several hours, nausea, generalized weakness. Chills and extreme fatigue lasted 4 hours. Low grade fever lasted 12 hours.
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| 61 | 2021-01-13 | nausea, diarrhea |
Headache for3 days Nausea for 3 days Muscle weakness for 3 days. Joint pain for 3 days. Red rash at ...
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Headache for3 days Nausea for 3 days Muscle weakness for 3 days. Joint pain for 3 days. Red rash at injection site. Swelling at injection site. Diarrhea for 2 Days
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| 61 | 2021-01-13 | nausea |
Pt received vaccine at 0730 on 1/11/2021. She developed fever, chill, body aches and headache at mid...
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Pt received vaccine at 0730 on 1/11/2021. She developed fever, chill, body aches and headache at midnight the same day. The following day shew had a fever a high as 103. She continued to feel fatigued, achy, headache, slightly nauseated and weak. Her symptoms improved over the course of the last 2 days. She is fever free today
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| 61 | 2021-01-13 | nausea |
Fever to 102 F. Chills. Total body aches. Severe headache. Nausea. All began around midnight, 1...
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Fever to 102 F. Chills. Total body aches. Severe headache. Nausea. All began around midnight, 16 hours post-shot. Worsened throughout the night and began to diminish about 8 hours later. After about 12 hours had only slight fever, more manageable headache, was achy all over and fatigued. Back to baseline 36 hours after onset of symptoms.
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| 61 | 2021-01-13 | nausea |
At time of shot, maybe 3 mins after, rush of hotness through entire body and severe nausea. Passed a...
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At time of shot, maybe 3 mins after, rush of hotness through entire body and severe nausea. Passed after about 4 mins then occurred a second time lasting for about 5 mins. Rested for about 45 mins before I felt well enough to drive. All better after about 2 hours.Next day, tired, sweaty, nauseous, lightheaded when standing.
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| 61 | 2021-01-14 | abdominal pain upper |
but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever; but then...
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but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever; but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever; Got the vaccine early Friday afternoon and had a sore arm; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the vaccine early Friday (08Jan2021) afternoon and had a sore arm but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever. The patient asked if that normal for side effects to occur 2 days later. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 61 | 2021-01-14 | abdominal pain, diarrhea |
Chills; Diarrhea; Again today 24 hours later she had abdominal cramping that was almost debilitating...
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Chills; Diarrhea; Again today 24 hours later she had abdominal cramping that was almost debilitating; Abdominal cramps; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on the right arm on 07Jan2021 07:00 at single dose for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications. The patient experienced abdominal cramps on 07Jan2021 13:30, diarrhea and chills for 20 or 30 minutes and then it all went away on 08Jan2021. Again today 24 hours later, she had abdominal cramping that was almost debilitating. Had Covid 19 Test up the nose test, thinks it was PCR that was negative on 06Nov2020. The outcome of events was recovered on 08Jan2021.
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| 61 | 2021-01-16 | decreased appetite |
"Pfizer-BioNTech COVID-19 Vaccine EUA", Injection site pain, Severe tiredness, mild headache, muscle...
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"Pfizer-BioNTech COVID-19 Vaccine EUA", Injection site pain, Severe tiredness, mild headache, muscle pain, fever, loss of appetite, HR in lower 90's, pulse OX in low 90's.
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| 61 | 2021-01-17 | decreased appetite, vomiting, nausea |
Was cold, took a shower, got out , couldn't get warm. Freezing and shaking, nausea, tingling in left...
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Was cold, took a shower, got out , couldn't get warm. Freezing and shaking, nausea, tingling in left side of face, joint pain, headache and neck pain. Lasted about 3 hours, shaking stopped but had chills that lasted all night. The next day, no appetite but when she ate something, she vomited. Worse things were shakes, headache and neck pain and vision. . Had vision problems. Eyes were swollen and jittery and hard to focus. The swelling went away but still unable to focus. Everything has gone except vision issue.
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| 61 | 2021-01-17 | nausea, abdominal pain, vomiting, constipation | Headaches, Chills, worst nausea and abdominal pain I?ve ever had in my life, vomiting |
| 61 | 2021-01-17 | nausea | Nausea & Headache |
| 61 | 2021-01-17 | vomiting, diarrhea |
Received Vaccine on 1/2/2021 at 10AM , at 3PM employee felt itchy, took a nap, and at 8PM she had a ...
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Received Vaccine on 1/2/2021 at 10AM , at 3PM employee felt itchy, took a nap, and at 8PM she had a circular redden skin rash on her arms, legs, and torso. Temperature: 99 degrees. Employee took Tylenol and Claritin for rash, complained of diarrhea, vomiting, and weakness of both knees within 24 hours all symptoms were gone.
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| 61 | 2021-01-18 | abdominal discomfort |
fatigue; headache; body aches; chills; cough; GI distress; high fever (102); This is a spontaneous r...
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fatigue; headache; body aches; chills; cough; GI distress; high fever (102); This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: expiry date: unknown) via an unspecified route of administration in the left arm, on 08Jan2021 at 17:00, at a single dose, for COVID-19 immunization. Relevant medical history included diabetes type 2, high blood pressure, hyperlipidemia, and glaucoma. Concomitant medications included orphenadrine (K-FLEX), empagliflozin (JARDIANCE), losartan, atorvastatin calcium (LIPITOR), and insulin. The previously took metformin and experienced allergies. Prior to vaccination, the patient was diagnosed with COVID-19. The patient is not pregnant at the time of vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 08Jan2021, at 18:00, the patient experienced fatigue, headache, body aches, chills, cough, gastrointestinal (GI) distress, and high fever (102). The patient did not receive treatment for the events. Outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 61 | 2021-01-18 | diarrhea, abdominal pain upper, nausea | nausea diarrhea extreme stomach pain |
| 61 | 2021-01-18 | diarrhea, nausea |
DIARRHEA 01/09, 01/10, 01/11, HEADACHE 01/09THRU 01/19 VERY TIRED 01/09 THRU 01/19 NAUSEA 01/09 TH...
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DIARRHEA 01/09, 01/10, 01/11, HEADACHE 01/09THRU 01/19 VERY TIRED 01/09 THRU 01/19 NAUSEA 01/09 THRU 01/19 SORE ARM 01/09 THRU 01/19
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| 61 | 2021-01-18 | difficulty swallowing |
itching of scalp, arms, legs; rash; abdominal hives; facial swelling; difficulty swallowing; swellin...
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itching of scalp, arms, legs; rash; abdominal hives; facial swelling; difficulty swallowing; swelling back of neck; inj site very sore; fatigue; This is a spontaneous report from a contactable nurse (patient). A 61-years-old female patient (no pregnant) started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK923) , via an unspecified route of administration on 29Dec2020 09:45 at the first single dose at arm left for covid-19 immunisation. Medical history included known allergies: Sulfa. The concomitant drug was unspecified. The patient previously took cipro and experienced drug hypersensitivity. On 29Dec2020, the patient expected side effect of inj site very sore and fatigue for 24 hours. On 06Jan2021 14:00, the patient started with itching of scalp, arms, legs ,rash, and abdominal hives. Proceeded to facial swelling and difficulty swallowing, swelling back of neck, took 50 mg Benadryl w some relief. 630 PM symptoms reoccurred, took another 50 mg Benadryl with no relief. Symptoms intensified to severe swelling of the back of neck with intense pressure base of skull, radiating to top of head. Proceeded to the ER. The patient received Prednisone 50 mg orally and for the 4 days. The outcome of event inj site very sore and fatigue was recovered on 30Dec2020; the outcome of events was recovered.
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| 61 | 2021-01-18 | nausea, decreased appetite |
Doesn't feel like eating; Fever; Chills/ Chilled; Nausea; Severe Headache/Dull headache/Frontal head...
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Doesn't feel like eating; Fever; Chills/ Chilled; Nausea; Severe Headache/Dull headache/Frontal headache; Fatigue; Body aches; This is a spontaneous report from a contactable Nurse (patient). This 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1686), via intramuscular, on 06Jan2021 (at 14:30) at single dose at left deltoid for COVID-19 immunisation, administered at hospital. Age at vaccination is 61-year-old. Historical vaccine included Diphtheria and Tetanus vaccine (intramuscular, at single dose) on 15Dec2020 for immunization; and Shingles vaccine (intramuscular, at single dose) on 15Dec2020 for varicella immunization. Relevant medical history included usual tenderness. No relevant concomitant medications were provided. On 07Jan2021, she woke up at 2:00 in the morning, she had a high temperature, she was chilled, she had a severe headache, nausea, fatigue, and body aches. She got up and took ibuprofen (ADVIL). She was basically in bed, she had to cancel all her appointments in the morning, she just laid in bed and the following afternoon her fever broke at about 4:30 in the afternoon then she just had a low grade temperature and a dull headache, nausea through the next day, Friday the 08Jan2021. She still has a very dull headache and just not right, kind of like a flu bug. She had no fever; she had not had any fever after Friday afternoon or Saturday. Fever started at 2 in the morning 07Jan2021 and she experienced the chills until after fever broke. Fever went above 102 degrees. She still had a little of the nausea, she just didn't feel like eating. She still had the dull headache. The nausea and headache have improved when compared to how it was on the 07Jan2021. She was back to work now she just has a dull frontal headache. The reporting nurse assessed all the events, except of 'Doesn't feel like eating', serious for disability. She stated she may have had usual tenderness but nothing like this. The patient had recovered from the event fever on 08Jan2021 and from the event 'chills/chilled' on 07Jan2021; the patient was recovering from 'nausea' and 'severe Headache/Dull headache/Frontal headache', while the outcome of the remaining events was unknown.; Sender's Comments: A possible contribution role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of the reported events cannot be excluded due to temporal relationship. It is worth noting that patient had other vaccines not far ago, including Diphtheria and Tetanus vaccine and Shingles vaccine on 15Dec2020 for immunization. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 61 | 2021-01-18 | nausea |
Cough; Headache; Dizzy; Nauseous; Low grade fever; Little Noxious, whole body aches completely aches...
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Cough; Headache; Dizzy; Nauseous; Low grade fever; Little Noxious, whole body aches completely aches my whole body like I have flu; Little Noxious, whole body aches completely aches my whole body like I have flu; Little Noxious, whole body aches completely aches my whole body like I have flu; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231 and expiration date 30Apr2021), via an unspecified route of administration on 07Jan2021 second dose at single dose for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medication included lisinopril for blood pressure. The patient stated that she took her second dose on 07Jan2021 afternoon and today 08Jan2021 the patient feel really cough "ing" (not clarified), light headache, dizzy. I am having fever "99.4" (not clarified). The patient asked are not they not safe to take Tylenol, is it okay to take Motrin or just have to be Tylenol (treatment)." It was clarified that patient experienced Dizziness, headache, fever, a low grade fever and little Nauseous. Just my whole body aches completely aches my whole body like I have the flu." The patient was treated with Tylenol for the events. The outcome of the events was unknown.
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| 61 | 2021-01-18 | vomiting, nausea | chills shakes nausea vomiting cough sob sore throat maliase |
| 61 | 2021-01-19 | diarrhea, nausea |
Second, dose 1/16/21 Pfizer LOT: EL3248 Saturday 11:30 am ? Side Effects started about 1.5 - 2 hours...
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Second, dose 1/16/21 Pfizer LOT: EL3248 Saturday 11:30 am ? Side Effects started about 1.5 - 2 hours after injection (I took 2 Tylenol and took a 3 hour nap) o Tired o Left Eye twitch o Blurred double vision o Headache o Nauseous ? Side Effects started about 5 - 6 hours after injection (I took 2 Tylenol a Benadryl and used my Ventolin inhalator) o Tired o Watering eyes o Sore tongue o Headache o Nauseous o Heavy feeling in chest ? Side Effects started some time during the night after injection o Muscle cramping in both legs and opposite arm of injection site o Low fever 100.3 Sunday side Effects (I took 2 Tylenol and took a 3-4 hour nap) o Tired o Left Eye twitch o Watering eyes o Sore tongue o Excessive thirst o Swollen neck glands o Nauseous (only after eating) o Muscle cramping in both calves o Blurry vision in the evening o Runny nose Monday side Effects (Went to work) o Tired o Left eye lid twitch o Swollen neck glands o Nauseous o Runny nose o Achy body o Diarrhea Tuesday side Effects (Went to work) o Left eyelid twitch o Swollen neck glands o Runny nose o Sore throat o Diarrhea BLOODY Wednesday side Effects (went to work) o Swollen neck glands o Runny nose o Sore throat Note: I have several Allergies that require me to take an allergy pill every day. I also use an inhaler as needed. My symptoms were not any worse than when I have a bad allergic reaction, I have received shots of Epinephrine for my allergies and did not feel one was necessary.
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| 61 | 2021-01-19 | difficulty swallowing |
After waiting 15 mins I developed a dry throat and walked to my car (8-10 mins later). Began to dev...
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After waiting 15 mins I developed a dry throat and walked to my car (8-10 mins later). Began to develop difficulty swallowing by the time I reached my car. Waited a few minutes and it did not abate and continued worsen,. Went to hospital's ER and was seen by Dr. At that time, my voice had become coarse and gravely. Was given oral steroid and a Benadryl. Symptoms lessened a bit and were gone after about 2 hours. While at first I thought my breathing wasn't affected, after symptoms cleared, I realized that my breathing was easier. Symptoms did not reoccur.
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| 61 | 2021-01-19 | nausea |
Dose 2 given at 1208 on 1/20/2021. At 1232 pt noticed flushing in the arms b/l, persistent pins and ...
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Dose 2 given at 1208 on 1/20/2021. At 1232 pt noticed flushing in the arms b/l, persistent pins and needles in arms, hands, and feet b/l, with "slight tingle" in lips. Unusual taste in mouth (that happened after 1st dose as well). Small wave of nausea. Sensation of heat in chest. At 1301 on 1/20/2021, 50 mg of IM Benadryl administered to RD (Lot # 080010, Exp 8/20/2022) by NP. At 1320, arms were less flushed, however b/l pins and needles persistent in both arms and feet, with "tingling" still in lips. Pt will wait until symptoms improve further to d/c to home. NP checking in continuously.
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| 61 | 2021-01-19 | vomiting |
Slightly sore left deltoid, cleared up in a few days. 16 hours after shot, experienced the dramatic...
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Slightly sore left deltoid, cleared up in a few days. 16 hours after shot, experienced the dramatic sensation of tilting while sitting on a couch. Had I been driving, this would likely have caused an accident. This is the first time I have ever experienced this feeling. There were 2 or 3 other episodes of feeling like I was falling. 2 of this happened while lying down. They were sudden sensations that made me gasp. Spent most of 1 week in bed with fatigue, vertigo, and 2 times vomiting. Vomiting occurred day 2 post vaccine. Fatigue was continuous for about a week. At day 16 now, certain movements still illicit vertigo. All vertigo symptoms have lasted under 1 minute. However, some have been back to back, such as after repositioning multiple times in bed. Ears have felt very full for almost 2 weeks. Certain head positions or movements, still illicit sensations of the room moving. There was no specific headache, but my head did not feel good for about 2 weeks. There was no fever, but there was chilling one night, a couple of days after the vaccine. I don't know if getting 2nd vaccine is wise.
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| 61 | 2021-01-20 | abdominal discomfort | Extremely tired dizzy feeling of vomiting upset stomach |
| 61 | 2021-01-20 | diarrhea |
Diarrhea about 6hrs after injection chills fever body aches and dull headache continued for about a...
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Diarrhea about 6hrs after injection chills fever body aches and dull headache continued for about another 24 hrs
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| 61 | 2021-01-20 | nausea, diarrhea, abdominal pain upper |
The first thing I had nausea and stomach pain (for 2 days) in the AM and then it went to achy, joint...
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The first thing I had nausea and stomach pain (for 2 days) in the AM and then it went to achy, joint hurting and headache. It was not like I could not work or anything, it was just there. On the 9th day I woke up with fever and chills and a super bad headache and I felt so bad I could not even go seek medical care, I finally went after 3 or 4 days feeling like that. At the walk in clinic they tested me for flu, covid and strep and on the rapid the result was negative but when done the PCR it came back positive (around 12/29/20). I did not have any respiratory issues on this one. I do remember having diarrhea.
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| 61 | 2021-01-20 | nausea |
felt very uncomfortable; Mental fogginess; Nausea; Dizziness/Lightheaded; Vertigo; Some extreme fati...
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felt very uncomfortable; Mental fogginess; Nausea; Dizziness/Lightheaded; Vertigo; Some extreme fatigue; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL0140 and Expiration Date: 31Mar2021), via an unspecified route of administration in the right deltoid on 27Dec2020 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included progesterone (MANUFACTURER UNKNOWN), estradiol (MANUFACTURER UNKNOWN), testosterone (MANUFACTURER UNKNOWN); all taken for hormonal treatment from an unspecified date to an unspecified date. The patient experienced the following events and outcomes: some extreme fatigue (non-serious) on 27Dec2020 with outcome of unknown, nausea (non-serious) on 31Dec2020 with outcome of unknown, dizziness/lightheaded (non-serious) on 31Dec2020 with outcome of unknown, vertigo (non-serious) on 31Dec2020 with outcome of unknown, felt very uncomfortable (non-serious) on an unspecified date with outcome of unknown, mental fogginess (non-serious) on an unspecified date with outcome of not recovered. The patient stated she wanted to report her experience with the first dose of the Pfizer Vaccine (COVID Vaccine), which was received on 27Dec2020. The patient stated she experienced some extreme fatigue starting that first day and then about four days later on 31Dec (not clarified), she experienced some nausea, some dizziness that advanced to vertigo and that occurred late at night; at the time she was getting ready for bed time around 22:00, but it just lasted for about one hour. The patient "went to bed just thinking about and staying in bed and then I felt very uncomfortable and I got up and then I went back to bed about at 01:30, that's how I just fell asleep." Then the next day, the patient was not feeling the vertigo, however, she was feeling lightheaded for about two days and then the fatigue continued to 08Jan (not clarified). Then starting on a Saturday, the patient "felt normal myself energetic and positive." The patient was still feeling mental fogginess, " I was getting here." The patient stated that dizziness and vertigo, or the mental fogginess were not listed on her list of possible side effects. The patient even asked her doctor what it would be, and the patient let her know that she received the vaccines. The events did not require any emergency room or physician office visits. The causality assessment from the reporting patient was reported as: "Yes, I believe it did."
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| 61 | 2021-01-21 | nausea, vomiting |
Headache 8:00pm to current 4:00pm 1-22-21 Nausea 6:00 am 1-22-21 to 3:00 pm Vomiting 8:00 am to 1:30...
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Headache 8:00pm to current 4:00pm 1-22-21 Nausea 6:00 am 1-22-21 to 3:00 pm Vomiting 8:00 am to 1:30 pm. Took zofran
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| 61 | 2021-01-21 | nausea |
Had when I woke up at 6 am set on Jan 22, 2021 still ongoing Sore throat, severe headache, nausea, ...
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Had when I woke up at 6 am set on Jan 22, 2021 still ongoing Sore throat, severe headache, nausea, muscle ache, light headness, dizzy. January 22, 2021 temp 100.1 tympanic
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| 61 | 2021-01-21 | nausea |
STarted having nausea around 10am on 1/21/21, then at noon started having chest pain and a migraine....
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STarted having nausea around 10am on 1/21/21, then at noon started having chest pain and a migraine. Went home early from work. As of 1/22/21 0830, still has chest pain but not as intense and it radiates to left shoulder and towards back (advised employee to have this evaluated)
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| 61 | 2021-01-24 | abdominal discomfort | 12 hours after shot Headache, stomach upset, fever 100.6, body aches x 36 hours |
| 61 | 2021-01-24 | vomiting, nausea | Chills. Fever. Nausea. Vomiting. Fainted |
| 61 | 2021-01-25 | nausea | Headache, nausea |
| 61 | 2021-01-25 | vomiting |
No problems with first vaccine. Started having severe head aches 2 days after the vaccine. Back Ache...
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No problems with first vaccine. Started having severe head aches 2 days after the vaccine. Back Ache after 5 days on the right side. Throwing up 6 days after for 3 days. Went to the hospital 10 days later for four days was taken by ambulance because she was to ill to drive.
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| 61 | 2021-01-26 | decreased appetite |
Approx 18 hours after the vaccine: Cold and hot flashes with chills (no fever) weakness, fatigue, sl...
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Approx 18 hours after the vaccine: Cold and hot flashes with chills (no fever) weakness, fatigue, slight left arm ache, loss of appetite, insomnia, body/joint aches. I took a couple of Aleve tabs 24 hours after the vaccine and then switched to 500 mg Tylenol 30 hours after the vaccine, with no relief of symptoms from either meds. I've been sleeping (taking 2 hour naps) and called off of work (I work in home health). Today, 1.27.21 I feel better, still having 'hot flashes' and some chills (again, without fever). I feel tired, slept last night for 12 hours (no further insomnia). I am eating, but really have no appetite.
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| 61 | 2021-01-26 | indigestion, vomiting |
Intense indigestion followed but intense vomiting; Intense indigestion followed but intense vomiting...
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Intense indigestion followed but intense vomiting; Intense indigestion followed but intense vomiting; This is a spontaneous report from a contactable Nurse reporting for herself. A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ej1685), via an unspecified route of administration at right arm on 23Dec2020 15:00 at single dose, then received the second dose of BNT162B2 (lot number: E10140), via an unspecified route of administration at left arm on 11Jan2021 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included hypertension, and depression, and allergy to latex. Concomitant medication included desvenlafaxine succinate (PRISTIQ), hydrochlorothiazide, olmesartan medoxomil (BENICAR HCT). Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced intense indigestion followed but intense vomiting on 25Dec2020 11:00. Occurred 48hours after 1st injection and 56 hours after 2nd. Was much more intense after 2nd injection. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on an unknown date in Jan2021.
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| 61 | 2021-01-26 | vomiting, nausea, indigestion |
Chills, low grade fever right away. Next 9 days--severe stomach burning, nausea, unable to hold flu...
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Chills, low grade fever right away. Next 9 days--severe stomach burning, nausea, unable to hold fluids down, "metal taste"--by day 9 went from 103 kg to 92 kg. Slowly got better after this with time and Pepto Bismol.
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| 61 | 2021-01-27 | decreased appetite, abdominal discomfort |
A little over 48 hours into my COVID19 shot (Pfizer), I got sick. I was freezing cold, slight headac...
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A little over 48 hours into my COVID19 shot (Pfizer), I got sick. I was freezing cold, slight headache, no appetite, and tired/achy. I slept for 3 hours and woke up a little after 8 p.m. Temperature was 100.5. After calling work and notifying my doctor, I drank a Powerade and went to bed. This morning, I feel almost normal. Slight headache (maybe from lack of food) and my stomach is still a little upset.
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| 61 | 2021-01-27 | difficulty swallowing |
10 -15 minutes after shot: Swelling of tongue; drainage from nose and back of throat;gourde voice; t...
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10 -15 minutes after shot: Swelling of tongue; drainage from nose and back of throat;gourde voice; trouble swallowing : elevated blood pressure Told nurse 25 minutes later.given benedryl injection Things improved and an hour later tongue began to swell again and blood press increased Paramedics called and they transported me to the ER where I was given an Epi injection and steroids. Monitored for three hours and sent home with prescription for steroids: epi pen; and zyrtec Still experiencing fatigue , headache and lots of drainage off and on
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| 61 | 2021-01-27 | nausea |
tired; sweaty; nauseous light headed when standing; rush of hotness through entire body; severe naus...
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tired; sweaty; nauseous light headed when standing; rush of hotness through entire body; severe nausea/nauseous light headed when standing; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (Lot number: 3302), via an unspecified route of administration in right arm on 13Jan2021 13:00 at single dose for covid-19 immunization. Medical history was none. Concomitant medication included escitalopram, vitamin d. At the time of shot, maybe 3 mins after, rush of hotness through entire body and severe nausea. Passed after about 4 mins then occurred a second time lasting for about 5 mins. Rested about 45 mins before feeling well enough to drive. All better after about 2 hours. Next day (14Jan2021), tired, sweaty, nauseous light headed when standing. No treatment received. No pregnant at the time of vaccination. The outcome of the events was unknown.
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| 61 | 2021-01-27 | nausea | FEVER, CHILLS, FATIGUE, NAUSEA; 12HR; TREATED WITH TYLENOL 650MG BID; EFFECTIVE |
| 61 | 2021-01-27 | nausea |
Fever 101; pain in both thigh; chills; nausea; headache; This is a spontaneous report from a contact...
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Fever 101; pain in both thigh; chills; nausea; headache; This is a spontaneous report from a contactable nurse (patient herself). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date not reported), via an unspecified route of administration in the left arm on 13Jan2021 13:00 at single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS). Concomitant medications were none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. On 14Jan2021 01:00, the patient experienced fever 101, pain in both thighs, chills, nausea and headache. No treatment was received for the adverse events. Clinical outcome of the events was recovered with sequelae on Jan2021.
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| 61 | 2021-01-27 | nausea |
FEVER, CHILLS, NAUSEA, FATIGUE, FLU-LIKE SYMPTOMS, TREATED WITH TYLENOL 650MG BID, EFFECTIVE - SYMT...
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FEVER, CHILLS, NAUSEA, FATIGUE, FLU-LIKE SYMPTOMS, TREATED WITH TYLENOL 650MG BID, EFFECTIVE - SYMTPOMS RESOLVED
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| 61 | 2021-01-27 | nausea |
headaches; achy feeling; nausea; felt hot; This is a spontaneous report from a contactable consumer ...
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headaches; achy feeling; nausea; felt hot; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3249) via an unspecified route of administration in the left arm on 12Jan2021 09:15 AM at a single dose for COVID vaccine. Medical history included rheumatoid arthritis. Concomitant medications included leflunomide, paroxetine, and ergocalciferol (VITAMIN D) (other medications in two weeks). The patient had no other vaccine in four weeks. The patient had known allergies to sulfamethoxazole/trimethoprim (SEPTRA) and mefloquine. It was reported that the patient had 4 days of headaches and achy feeling on 12Jan2021. During her 30-minute wait after the injection, she experienced some nausea and felt hot on 12Jan2021. Treatment was not received for the events. The patient had no COVID prior vaccination. She did not have COVID tested post vaccination. The outcome of the events was recovering.
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| 61 | 2021-01-29 | diarrhea |
alost fainted- very pale, then tachycardia, high blood pressure, diarrhea. This reoccurred i waves ...
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alost fainted- very pale, then tachycardia, high blood pressure, diarrhea. This reoccurred i waves over the next week. Also fatique,, muscle and joint pain. for 6 days also had sever headace, numbness in face and lips, spasm of left eyebrow. Mised wek of work, ended up in Emergency room. Had negative covid test. sent home. Was fatiques and dizzy and brain fog for next three weeks. Took a month to feel rigtht.
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| 61 | 2021-01-29 | nausea | Numbness around my mouth, chills, and nausea |
| 61 | 2021-01-30 | nausea |
12 hr after vaccine, sore arm, a little achy. 15 hrs after vaccine (11 pm) and through the night, fe...
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12 hr after vaccine, sore arm, a little achy. 15 hrs after vaccine (11 pm) and through the night, felt very cold and had difficulty getting warm, headache, all body achy, unable to get into any comfortable position and very limited sleep. By 24 hr after vaccine and continuing until 40 hr after, nausea most of day, severe muscle pains, headache, difficulty moving from pain and general weakness, head swimming sensation. felt like skin crawling sensation all over. By 48 hrs, much less headache and nausea, able to eat, still had skin crawling sensation and achy but able to walk around a bit, not able to go outside. By 58 hr after (at time of report), just weak all over feeling, head fuzzy but better. Treatment: ondansetron x 2 doses (at 24 hr and 20 hr), Nurtec x 2 doses at 15 hr and 20 hr), Acetaminophen 8 hr x 2 doses (at 36 hr and 48 hrs)
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| 61 | 2021-01-30 | vomiting |
Metallic taste in her mouth. Violent shaking for 11.5 hours and pulled muscles in her stomach and b...
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Metallic taste in her mouth. Violent shaking for 11.5 hours and pulled muscles in her stomach and back. Injection site hot. Fingers on that side were white Dizziness. H/A. Vomiting
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| 61 | 2021-01-31 | diarrhea |
Severe sudden diarrhea, headache, weakness, taste of smoke with burning sensation. Today unable to...
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Severe sudden diarrhea, headache, weakness, taste of smoke with burning sensation. Today unable to do anything, very tired.
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| 61 | 2021-01-31 | nausea, diarrhea | headache in the frontal lobe nausea diarrhea dizzy |
| 61 | 2021-01-31 | nausea, diarrhea | Headache, Chills, Nausea, Diarrhea, Malaise |
| 61 | 2021-01-31 | nausea |
Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Other- CHEST TIGHTNESS,TROUBLE BREATHI...
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Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Other- CHEST TIGHTNESS,TROUBLE BREATHING-Medium
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| 61 | 2021-01-31 | nausea |
Patient's reaction(s) noted during COVID vaccine observation period: At 1700, patient had left obs...
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Patient's reaction(s) noted during COVID vaccine observation period: At 1700, patient had left observation area, gotten to car, drove away but returned because she was experiencing nausea and headache. Patient was seated, used wet cloth to forehead and back of neck. VS: B/P 127/86, HR 98, O2 sat 98%, Temp 98.0. At 1715 VS: B/P 124/76, HR 88, O2 sat 98%, temp 98.1. At 1730 VS: B/P 121/91, Hr 86, O2 sat 98%,. Still c/o headache, refused tylenol. Nausea still present but slightly improved. Reassured by staff and husband and taking sips of Sprite 1745 B/P 118/64, HR 85, )2 sat 98%, nausea improving still has H/A, states these symptoms have occurred in past with other events. 1800 B/P 117/69, HR 89, O2 sat 98%. Was walked out to car, denies lightheadedness or shortness of breath. States other symptoms are improving. Disposition: Declined going to ED. Left to go home with no further concerns.
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| 61 | 2021-01-31 | vomiting | Chills & Vomiting |
| 61 | 2021-02-01 | diarrhea, stomatitis, vomiting |
lost 22lbs; teeth hurting; can't eat; sores in mouth; cold chills; Headache/it's mainly in the back ...
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lost 22lbs; teeth hurting; can't eat; sores in mouth; cold chills; Headache/it's mainly in the back of her head; Diarrhea; Throwing up/threw up 4 times; low grade temp of 100; This is Spontaneous report from a contactable consumer reporting for self. A 61-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration in Right arm on 14Jan2021 10:00 at single dose for covid-19 immunisation. Patient received 1st dose of bnt162b2 on 24Dec2020, Lot number: EL0140; She only had a little aches with the first dose. States that she has had Covid before. There were no concomitant medications. She got the 2nd covid vaccine and felt like she got Covid all over again, diarrhea, throwing up, cold chills, and headaches started on 15Jan2021 at around 2:00AM, low grade temp of 100 on 15Jan2021, then she got sores in her mouth and now her teeth hurt. States that maybe it's from the fever. States that she can't eat because it hurts. She lost 22lbs because she couldn't eat. She has been gargling with half warm water and half peroxide. States that she threw up 4 times, but she doesn't even remember how many times she had diarrhea. After she was done throwing up she finally sat down and took her temperature, so it was probably around 4:00-5:00 AM. States that she still has a headache; it's mainly in the back of her head. Outcome of event diarrhea, throwing up, low grade temp of 100, chills was recovered, of headache was recovering, of can't eat and lost 22lbs was unknown, of others was not recovered.
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| 61 | 2021-02-01 | nausea |
very sore Painful arm at injection site; Started chilling; ran a fever between 102- 103 degrees; hea...
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very sore Painful arm at injection site; Started chilling; ran a fever between 102- 103 degrees; headache; felt nauseous; This is a spontaneous report from a contactable nurse (patient). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration in left arm on 18Jan2021 10:00 at first single dose for COVID-19 immunization. Medical history included high blood pressure (BP) on medication, known allergies: Penicillin (PCN), levaquin, covid-19 on 18Nov2020. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient had a very sore painful arm at injection site, no redness, started chilling and ran a fever between 102- 103 degrees during the night and into the next day. Had headache felt nauseous. Events start date/time: 19Jan2021 02:00 AM. By 6 pm the next day the patient started to feel a little better. The patient tested positive for covid 19 in 18Nov2020. Covid was not tested post vaccination. No treatment was received for the events. Outcome of the events was recovering.
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| 61 | 2021-02-02 | abdominal pain upper |
Patient reported stomach cramping and had 5 bowel movements after vaccine. Stated was nervous for t...
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Patient reported stomach cramping and had 5 bowel movements after vaccine. Stated was nervous for the shot. Took blood pressure 137/80. No diarrhea bowel movements were normal. Monitored pt and she felt better and reported still a little cramping but much better.
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| 61 | 2021-02-03 | abdominal discomfort |
a few days after the 1st I had intestinal discomfort, two days later I was passing only mucus, two d...
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a few days after the 1st I had intestinal discomfort, two days later I was passing only mucus, two days later blood was mixed with the mucus. two days later it was mostly blood. After the 2nd dose, the bleeding increased and went to 100% blood. The bleeding lasted a total of 18 days. My GI appointment was a few days later.
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| 61 | 2021-02-03 | diarrhea |
Diarrhea; Chills; Slight headache; Very body tired; This is a spontaneous report from a contactable ...
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Diarrhea; Chills; Slight headache; Very body tired; This is a spontaneous report from a contactable other HCP reported for herself that a 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: p9231), via an unspecified route of administration at the age of 61-years, on 22Jan2021 17:00 (05:00 PM) at single dose in left arm for COVID-19 immunization, in hospital. Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient had slight headache on 23Jan2021 and was very body tired. On 24Jan2021 10:00 AM, she had diarrhea and chills. No treatment received for the adverse events. The events were considered as non-serious. Outcome of the events was recovering/resolving. Since the vaccination, the patient has not been tested for COVID-19.
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| 61 | 2021-02-03 | diarrhea |
Headaches, dizziness, loose stool, upper body pain, 8/10 for 15 minutes (Felt like a heart attack an...
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Headaches, dizziness, loose stool, upper body pain, 8/10 for 15 minutes (Felt like a heart attack and then gone completely after 10 minutes)
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| 61 | 2021-02-04 | difficulty swallowing |
Difficulty swallowing, tongue swelling, headache, Epi pen 0.3mg, 25 mg Benadryl Improvement in tong...
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Difficulty swallowing, tongue swelling, headache, Epi pen 0.3mg, 25 mg Benadryl Improvement in tongue swelling
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| 61 | 2021-02-04 | nausea |
Pfizer-BioNTech COVID-19 Vaccine EUA Approximately 3 mins after vaccination, pt reports nausea, diz...
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Pfizer-BioNTech COVID-19 Vaccine EUA Approximately 3 mins after vaccination, pt reports nausea, dizziness, chest pressure, and profound weakness. Brought to Emergency Department by crisis RN where she remains achy with weakness, fatigue and had no energy. Pt reports "feeling tired" and "my speech is slower". On exam, slight R facial droop noted, tongue noted to be leaning towards the right, pronator drift noted in R arm. Code Brain activated with real time audio video interaction. MRI completed with normal results. Symptoms resolved. Stroke team ok with discharge to home with f/u with PCP.
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| 61 | 2021-02-06 | nausea, abdominal pain |
I am not sure this is what i shoud be filling out - just wanted to report what seemed like pretty ba...
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I am not sure this is what i shoud be filling out - just wanted to report what seemed like pretty bad symptoms on first dose by all info i have found. The actual shot was given by another facility than listed previously. I recieved the first dose of Pfizer at Health Dept . No other location information was provided by them. When i got the shot, a blood vein and possibly a nerve was hit. The nurse did everything properly i think to correct and notify other RN. It caused immediate pain in left fingers and arm felt heavy. That continued for days, but not too bad and injection site itself really was not very sore. My concern was how sick I felt starting within 6 hours of the injection and how long it lasted. I had pretty much instant nausea- no vomiting- mild but persistant, severe fatigue and general overall uneasy/sick feeling. Joint pain started within the 6 hours, along with a few odd pains in neck and right abdomen. Was extremely chilled for hours, pretty bad tension /tight feeling headache, jittery feeling and foggy. I took a 500mg Tylenol about 8 hours after the shot, and it helped to relieve most symptoms to a degree that was nagging, but tolerable. I pretty much went through this for about the next 3 days and off/on to the 5th day
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| 61 | 2021-02-07 | indigestion | indigestion |
| 61 | 2021-02-07 | nausea | Sore arm. Nausea. Fatigue |
| 61 | 2021-02-08 | nausea, abdominal discomfort, abdominal pain |
On 2/5 am felt dizzy and nauseated. On 2/6 am felt dizzy and nauseated On 2/7 had child, abdominal ...
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On 2/5 am felt dizzy and nauseated. On 2/6 am felt dizzy and nauseated On 2/7 had child, abdominal cramping and pain , Temp 99.3 On 2/8 stomach uncomfortable, fatigue and muscle aches. 2/9 feel tired
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| 61 | 2021-02-08 | nausea | Chills, fever up to 101.2 F, body aches, and nausea, lasting 40 hours. |
| 61 | 2021-02-09 | nausea |
I had flu like symptoms headache and dizziness with both doses. The symptoms of the first dose stopp...
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I had flu like symptoms headache and dizziness with both doses. The symptoms of the first dose stopped at day 3. After the second dose, 3 weeks later, the symptoms appeared later but held on to day 5 or 6, except the more extreme dizziness which I still have. It is worse on some days and there is some nausea in the mornings with headache. I have never had vertigo but this is what I imagine it to be.
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| 61 | 2021-02-09 | vomiting, nausea |
splitting headaches; chronic nausea; Vomiting is explosive and unpredictable; metallic taste in mout...
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splitting headaches; chronic nausea; Vomiting is explosive and unpredictable; metallic taste in mouth for 3 days.; This is a spontaneous report from a contactable other hcp, the patient. This 61-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EK5730), dose number 1, via an unspecified route of administration in the right arm on 29Dec2020 at 11:00 (at the age of 61-years-old) as a single dose for COVID-19 immunization. Medical history included type 1 diabetes mellitus from 1974 to an unknown date (T1DM dx 1974) and aortic valve replacement from 1990 and unknown if ongoing (AVR 1990 and 1992). Concomitant medication included insulin (INSULIN), simvastatin (SIMVASTATIN) and lisinopril (LISINOPRIL). The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. On 31Dec2020, the patient experienced metallic taste in mouth for 3 days. On 07Jan2021 at 13:00, the patient experienced splitting headaches, chronic nausea began and vomiting which was explosive and unpredictable. No therapeutic measures were taken as a result of the events. The clinical outcomes of the metallic taste in mouth for 3 days, splitting headaches, vomiting and chronic nausea were not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 61 | 2021-02-10 | abdominal pain upper | Chills, body aches, headache, stomach ache Duration = 60 hours |
| 61 | 2021-02-10 | nausea |
Injection Site Pain, tiredness, headache severe, muscle pain, chills, joint pain, fever, nausea, fee...
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Injection Site Pain, tiredness, headache severe, muscle pain, chills, joint pain, fever, nausea, feeling unwell, cough
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| 61 | 2021-02-14 | nausea |
Severe all arm pain for short period of time, chills, headache, fatigue, swollen lymph nodes and con...
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Severe all arm pain for short period of time, chills, headache, fatigue, swollen lymph nodes and continuing nausea.
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| 61 | 2021-02-16 | diarrhea, nausea |
Mouth and tongue (top and bottom) numb and stinging, facial swelling and red rash - 5 days Fever 101...
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Mouth and tongue (top and bottom) numb and stinging, facial swelling and red rash - 5 days Fever 101 - 2 days headache - 5 days nausea - still have diarrhea - 6 days Sore and stinging left arm (received vaccine), sore upper and lower back and neck. Felt like I was kicked in those areas - still have Fatigue - 6 days, lessening Toes bright red at the top and are painful, areas on bottom of toe as well - still have
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| 61 | 2021-02-16 | diarrhea, nausea |
61 yo F with history of bilateral lung transplant 6/23/17 presented to ED on 2/4/21 with chief compl...
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61 yo F with history of bilateral lung transplant 6/23/17 presented to ED on 2/4/21 with chief complaint of worsening shortness of breath, nausea and diarrhea for past week since receiving since receiving COVID-19 vaccine (Pfizer) on 1/28/21. Upon arrival to triage she was obviously dyspneic with significantly low oxygen saturations. O2 sats on arrival were 65%, improved to mid 90's with O2 6 liters per NC. Admitting diagnosis: hypoxic respiratory failure post COVID vaccine. Lab work shows an elevation of the BUN and creatinine at 31 and 1.71 which is slightly higher than her usual baseline levels. BNP is elevated at 2 448 with a mildly elevated troponin. Procalcitonin is also elevated. Patient's white blood cell count is 11.07. Full viral panel including COVID-19 is not detected. All blood cultures and respiratory cultures were negative. Patient chest x-ray shows numerous bilateral patchy opacities which is significantly different from her previous chest x-ray here. Empiric rejection treatment initiated including high dose methylprednisolone, plasmapheresis, IVIG, Thymoglobulin. She continued to decline and ultimately required intubation, proning and paralyzing on 2/8/2021 and then VV ECMO cannulation on 2/13/2021. EGD done 2/14/2021 as unable to pass the TEE probe during cannulation prior day (unable to complete due to abnormal anatomy). Acute pupil exam change in the early am hours of 2/15/2021 prompted urgent head CT which revealed catastrophic brain bleed. Brainstem reflexes were lost soon after. Despite placing an EVD emergently at bedside, brain stem reflexes were not recovered. GOL engaged and patient not an organ donation candidate. Therefore discussion with sister at bedside resulted in decision for cessation of life support. Patient expired shortly after support withdrawn and pronounced dead on 2/15/2021 at 11:11 AM.
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| 61 | 2021-02-16 | nausea |
almost like she also had some mild hearing loss; nausea; exacerbation of migraine with paresthesia a...
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almost like she also had some mild hearing loss; nausea; exacerbation of migraine with paresthesia and tinnitus/ headaches/migraines; exacerbation of migraine with paresthesia and tinnitus; exacerbation of migraine with paresthesia and tinnitus/ increased tinnitus; some abdominal tightness; This is a spontaneous report from a contactable pharmacist (patient herself) via Medical Information team. A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3302, NDC number/expiration date was unknown), via an unspecified route of administration on the left arm (also reported as upper left arm) on 13Jan2021 at 09:00 at a single dose for COVID-19 immunization; the patient was a healthcare worker and was trying to protect herself. The vaccination facility type was reported as a drive thru site. Relevant medical history included previous neurological problems, which included history of underlying migraine with paresthesia/chronic paresthesia (ongoing) and tinnitus. The patient had no family medical history relevant to the adverse events (AEs). There were no concomitant medications. The patient had no other vaccine received on the same day of the Pfizer suspect or 4 weeks prior. She never had any problems with vaccines in the past. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Initially, the patient was asking if there were any reports of paresthesia, serious neurologic adverse events, tinnitus, hearing loss, or abdominal tightness in the studies for the Pfizer-Biontech Covid-19 vaccine. After the patient received the first dose of the Pfizer-BioNTech COVID-19 vaccine on 13Jan2021, she experienced an exacerbation of migraine with paresthesia and tinnitus. She also reported experiencing some abdominal tightness on an unspecified date in Jan2021. The patient reported she was scheduled for her second dose of the Pfizer COVID-19 vaccine, but had concerns because she was still experiencing tinnitus and it was "almost like she also had some mild hearing loss" on an unspecified date. The patient further reported that she was due for the next dose the following day at the time of the report (03Feb2021). She had previous neurological problems and did not know if this did exacerbate things or not. She had migraines, tinnitus, and paresthesia and was wondering how many other patients with neurological problems reported this and was this a common side effect or adverse event reported. One doctor told her not to get the second dose and another one told her to get it and she wanted to know what she should do. The patient had headaches/migraines on the evening of vaccination on 13Jan2021 that were fairly mild and 3 days after that on 16Jan2021, they got bad and was accompanied with nausea with increased tinnitus. The migraines and nausea had gone, and the chronic paresthesia was the same as she always had, but the tinnitus was a lot louder and worse. The patient also mentioned that her migraines usually go away, but this one had lingered. The AEs did not require any visit to an emergency room or a physician office. There were no investigation assessment. The patient recovered from the event "nausea" on an unspecified date, she was recovering from the event "exacerbation of migraine/ headaches/migraines," she was not recovered from the events "exacerbation of paresthesia and tinnitus/increased tinnitus, while the outcome of the events "almost like she also had some mild hearing loss and some abdominal tightness" was unknown. The reporter assessed the events "migraine, tinnitus, paresthesia, and nausea" as serious, other medically important conditions. The relatedness of drug to the reactions/events "migraine, tinnitus, paresthesia, and nausea" was unknown as per the reporting pharmacist (Method of assessment: Global Introspection).; Sender's Comments: The 61-year-old female had relevant medical history included previous neurological problems. The reported neurological events and partial hearing loss were more likely due to pre-existing conditions, and less likely related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE). Event nausea was likely due to the first dose of bnt162b2. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 61 | 2021-02-18 | nausea |
Around 1 am on 1/29/2021, hot flashes, fever 99, & a little bit nauseas this lasted 48hrs. My legs f...
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Around 1 am on 1/29/2021, hot flashes, fever 99, & a little bit nauseas this lasted 48hrs. My legs felt weak & shaky legs and fuzzy head. I feel with no energy. This symptoms are still going on.
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| 61 | 2021-02-18 | nausea |
Over a 3 day period, I had chills, fever, entire body aches (I could barely move), nausea, EXTREME l...
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Over a 3 day period, I had chills, fever, entire body aches (I could barely move), nausea, EXTREME labored breathing. Symptoms were more severe than the actual covid virus I had.
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| 61 | 2021-02-21 | vomiting | Vomiting, rash, dizziness, weakness |
| 61 | 2021-02-22 | nausea, vomiting | nausea, vomiting, headache, tired, chills, pain in injection site |
| 61 | 2021-02-23 | abdominal pain upper |
Extreme lower stomach pain; Could not move for 3 days; dehydration; fatigue; speech issues; This is ...
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Extreme lower stomach pain; Could not move for 3 days; dehydration; fatigue; speech issues; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration (anatomical location/vaccination location: arm left) on 29Jan2021 13:30 at SINGLE DOSE for COVID-19 immunisation. Medical history included bad back, penicillin allergy, and covid prior vaccination all from unknown dates and unknown if ongoing. The patient has not had other vaccine in four weeks. Patient was not pregnant. Concomitant medication included oxycodone hydrochloride (OXYCONTIN). The patient experienced extreme lower stomach pain, could not move for 3 days, dehydration, fatigue, and speech issues (all events assessed as serious - disability) all on 05Feb2021 17:00. Patient's clinical course is as follows: One week after the shot, patient had extreme lower stomach pain, could not move for 3 days, dehydration, fatigue, and speech issues then continued for 2 more days. No treatment was provided for the events. It was reported that patient was COVID tested post vaccination. The patient underwent lab tests and procedures which included nasal swab with result of negative on 20Jan2021. Facility type vaccine was reported as nursing home. Outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 61 | 2021-02-23 | nausea, diarrhea |
chest x-ray shows numerous bilateral patchy opacities; catastrophic brain bleed; Brainstem reflexes ...
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chest x-ray shows numerous bilateral patchy opacities; catastrophic brain bleed; Brainstem reflexes were lost; Patient died; shortness of breath; nausea; diarrhea; worsening shortness of breath/numerous bilateral patchy opacities; immunosuppressed status; This is a spontaneous report from a contactable pharmacist and a contactable other health professional. A 61-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), intramuscular at arm right on 28Jan2021 (at the age of 61 years) at single dose for COVID-19 immunization. The patient medical history included bilateral lung transplant on 23Jun2017, lymphangioleiomyomatosis, hepatocellular carcinoma, antibody mediated rejection of lung transplant , bronchiolitis obliterans syndrome, grade 0P, major depressive disorder, RLS (restless legs syndrome), chronic insomnia, long term current use of systemic steroids OSA (obstructive sleep apnea), iron deficiency anemia, bilateral sciatica, hoarseness of voice, memory change, laryngeal stridor, pure hypercholesterolemia senile nuclear cataract, bilateral myopia of both eyes, osteoporosis without current pathological fracture, alopecia, immunosuppressed status, all from an unknown date and unknown if ongoing. Concomitant medication included acyclovir (formulation: capsule, strength: 200 mg) oral at 200 mg twice daily, salbutamol (ALBUTEROL HFA) as needed (MCG/ACT inhaler take 2 puffs by inhalation every 4 hours as needed) for wheezing (shortness of breath), atorvastatin (LIPITOR, formulation: tablet) oral at 80 mg once a day, azithromycin (ZITHROMAX, formulation: tablet)oral at 250 mg (every Monday, Wednesday, Friday), bupropion hydrochloride (WELLBUTRIN XL, formulation: tablet, strength: 150 mg) oral at 150 mg once a day, calcium citrate/cholecalciferol (CALCIUM + VITAMIN D, formulation: tablet) oral at 2 dose form once a day (every morning), everolimus (ZORTRESS, formulation: tablet, strength: 1 mg) oral at 2 mg twice a day, fluticasone propionate/salmeterol xinafoate (ADVAIR, strength: 500 ug/ 20 ug) twice daily (1 puff by inhalation), gabapentin (NEURONTIN, formulation: capsule, strength:100 mg) oral at 300 mg daily (by mouth nightly), loratadine (CLARITIN, formulation: tablet, strength: 10 mg) oral at 10 mg as needed, metoprolol tartrate (LOPRESSOR, formulation: tablet, strength: 25 mg)oral at 50 mg twice daily, minoxidil (ROGAN, strength: 5%) topical apply 1 cap full every other day to affected area on scalp for alopecia, ondansetron (ZOFRAN, formulation: tablet, strength: 4 mg) oral at 4 mg as needed for nausea, pantoprazole sodium sesquihydrate (PROTONIX, formulation: tablet, strength: 40 mg) oral at 40 mg once a day, prednisone (DELTASONE, formulation: tablet, strength: 5 mg) oral at 5 mg daily (every morning), sertraline hydrochloride (ZOLOFT, formulation: tablet, strength: 100 mg) oral at 100 mg twice a day (every morning), sulfamethoxazole/trimethoprim (BACTRIM) 400-80 mg per tablet (1 tablet by mouth every Monday, Wednesday, Friday), tacrolimus (formulation: capsule) at 3 mg daily (2 mg every morning and 1 mg at night), salbutamol sulfate (PROVENTIL HFA) as needed for wheezing (shortness of breath), salbutamol sulfate (VENTOLIN HFA) as needed for wheezing (shortness of breath) , salbutamol sulfate (PROAIR HFA) as needed for wheezing (shortness of breath), ascorbic acid/ferrous fumarate/folic acid/ retinol (PRENATAL, formulation: tablet) oral daily. The patient previously took NSAIDs and voriconazole and experienced drug allergies. It was reported that the patient presented to emergency department (ED) on 04Feb2021 with chief complaint of worsening shortness of breath, nausea and diarrhea for past week since receiving since receiving COVID-19 vaccine. Full viral panel including COVID-19 was not detected. All blood cultures and respiratory cultures were negative. Patient chest x-ray shows numerous bilateral patchy opacities which is significantly different from her previous chest x-ray here. Empiric rejection treatment initiated including high dose methylprednisolone, plasmapheresis, IVIG, thymoglobulin. She continued to decline and ultimately required intubation, proning and paralyzing on 08Feb2021 and then VV ECMO cannulation on 13Feb2021. Acute pupil exam changes in the early am hours of 15Feb2021 prompted urgent head CT which revealed catastrophic brain bleed. Brainstem reflexes were lost soon after. Despite placing an EVD emergently at bedside, brain stem reflexes were not recovered. The events were all serious. The patient outcome of the events was fatal. The patient died on 15Feb2021. It was not reported if an autopsy was performed.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship. However, the reported event may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Chest x-ray shows numerous bilateral patchy opacities; Catastrophic brain bleed; Brainstem reflexes were lost; shortness of breath; nausea; Diarrhea; Worsening shortness of breath/numerous bilateral patchy opacities
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| 61 | 2021-02-23 | nausea | 1. Facial numbness 2. Nausea 3. Pain in back of neck 4. Headache |
| 61 | 2021-02-24 | abdominal pain |
Pain on right-side of back all the way to front of chest and under breast and part of right shoulder...
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Pain on right-side of back all the way to front of chest and under breast and part of right shoulder. Week prior felt sensation of "pins and needles" on back. Patient reports 1 blister spot on chest. Patient went to urgent care and was diagnosed with shingles. Doctor prescribed Valtrex and Ibuprofen.
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| 61 | 2021-02-25 | diarrhea, nausea | [COVID-19 mRNA vaccine (Pfizer-BioNtech] treatment under Emergency Use Authorization (EUA) |
| 61 | 2021-02-25 | difficulty swallowing |
chills, fever 3-4 hours after vaccine administration injection site pain: took Tylenol 1200mg, helpe...
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chills, fever 3-4 hours after vaccine administration injection site pain: took Tylenol 1200mg, helped. Limited range of motion noted on L arm, could not lift arm ROM more than 30 degrees 12 hours after vaccine still had chills, and fever. Then started to itching on both hands, noticed and uncontrollable itching. Took Benadryl 25mg and feel asleep. hives and itching was gone by the time she woke up. Severe fever and body aches 22 hours after vaccine administration. Temperature was 101.8. Throat felt "sore, with some little difficulty swallowing", took Tylenol 1200mg and Vit C 2000mg and Vit D 10,000 IU and Zinc 100mg. Today, 48 hours after vaccine administration, having systemic hives, and eyes are puffy and swollen, R eye more than left, upper lid is swollen. Took Claritin 10mg and Famotidine 20mg. Hives are better but not fully resolved, but itching is persistent. Still discomfort noted in swallowing.
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| 61 | 2021-02-27 | nausea |
Had chills, nausea and ringing in the head/ears about 4 hours after the first shot. The chills and n...
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Had chills, nausea and ringing in the head/ears about 4 hours after the first shot. The chills and nausea stopped by the next morning. But the ringing in my head/ears is still going on. It?s driving me crazy. It?s a high pitch buzzing sound that never stops. At times I feel dizzy and nauseous because of it.
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| 61 | 2021-02-28 | nausea, diarrhea |
Nothing too horrible... Nasseau periods, and diarrhea for 2 days, slight headache. I took some pept...
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Nothing too horrible... Nasseau periods, and diarrhea for 2 days, slight headache. I took some pepto bismol today. Hope it helps. I am still not sure if these are due to the vaccine or not?
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| 61 | 2021-02-28 | nausea, vomiting |
Localized rash; High fever; Nausea; Vomiting; Dizziness; Rapid heart rate; it was after the shot, if...
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Localized rash; High fever; Nausea; Vomiting; Dizziness; Rapid heart rate; it was after the shot, if she pressed where the injection was it is still a little sore; She called in sick last week; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686 and expiration date not provided), via an unspecified route of administration in the right arm on 19Jan2021 13:30 at a single dose for COVID-19 vaccination. Medical history included Blood pressure high diagnosed a couple years ago. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) for COVID-19 immunization on 29Dec2020 and unspecified flu shot last fall, she thinks in Sep or Oct2020, but she has never had problems with those. Concomitant medications included unspecified medications. The patient called and said she had reaction to the Pfizer COVID-19 vaccine 12 hours after her second dose and wanted to report it. She said also this past weekend, on Sunday, on 24Jan2021, she started to develop a localized rash that has like a border to it. She added that she got her second dose of the COVID-19 vaccine on 19Jan2021 at about 01:30 PM in her right arm. She said that she woke up the next morning, 20Jan2021 at 03:00 AM with a high fever, nausea, vomiting, dizziness, and rapid heart rate. She said that the high fever that started the temperature she took was 103 initially, she says she took paracetamol (TYLENOL) and it came down to 101, and the next day it was probably 100 most of the day, then it broke that evening. She said the Tylenol, the dose was the extra strength, unknown if it was 500 mg, they were capsules. She says she normally doesn't keep it around, the in-house nurse suggested it so she went and got a sample thing and took a couple doses, she doesn't have it with her as she is at work and is not at home. She said that the nausea and vomiting subsided after the first day or second day, she had the on and off fever and slept most of the day both days. She said that she doesn't have a fever now. She said that she doesn't have her exact heart rate from when she was having the rapid heart rate, she just felt it in her chest. She added that the only reason she said anything was because she called in sick last week on an unspecified date in Jan2021. She said that the rash started developing after that and it is now probably the size of a 16 oz or 60 oz cup, unable to clarify number with caller, she said that it is definitely big but it doesn't bother her, though she is concerned it is there. She clarified that it is a couple inches in diameter and kind of looks like the state of (State Name), on her injection arm which was her right arm. She said her arm is not sore now, it was after the shot on an unspecified date in Jan2021, if she pressed where the injection was it is still a little sore. She said that the hospital said to report it. She said she also has a concern if she should she get another shot if they decide this is needed for more than two vaccinations. She said that she knows they are still gathering information at this point, so she thought she should better turn in, hopefully there will be solution later on. The outcome of the events localized rash, dizziness, heart rate increased and sickness was unknown. The outcome of the events fever, nausea and vomiting was recovered on an unspecified date in Jan2021 while the outcome of the event vaccination site pain is recovering.
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| 61 | 2021-02-28 | vomiting |
arm/joint pain, vomiting chills low grade fever overnight, headache. Severe pain in shoulders, hips ...
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arm/joint pain, vomiting chills low grade fever overnight, headache. Severe pain in shoulders, hips and lower back lasted 3 days. lymph nodes in armpits very sore. headache lasted 2 days. vomiting lasted 8 hrs. fever(99-101) lasted 2 days. had 3 minor breathing incidents which was alleviated by using rescue inhaler(albuterol) Called in to Health Service and messaged primary care, was advised to take advil, tylenol, lots fluids and get tested for COVID19.
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| 61 | 2021-03-01 | diarrhea |
Moderate fatigue - unresolved mild headache - unresolved diarrhea - resolved 2/19/2021 joint pain - ...
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Moderate fatigue - unresolved mild headache - unresolved diarrhea - resolved 2/19/2021 joint pain - resolved 2/22/21 increased blood pressure - resolved 2/19/2021 swollen eye lids and upper checks - resolved 2/22/2021
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| 61 | 2021-03-01 | nausea, decreased appetite |
Chills and headache beginning 10 pm of the day of injection, followed by fever, nausea, body aches, ...
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Chills and headache beginning 10 pm of the day of injection, followed by fever, nausea, body aches, sinus congestion soon thereafter and extreme fatigue. Aleve (2 tablets) at 7 am the next morning with little, if any, relief but perhaps prevented it from becoming worse and another at 2:30 am on Monday morning (the second day). Slept, although not always well, for the better part of 32 hours, with less than 3 hours of being awake and up, trying to eat little. Was able to make it through a nine hour shift on Monday, still with no appetite and a bit off (attributed to not being truly rested despite 32 hours in bed).
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| 61 | 2021-03-01 | nausea |
Fever, chills, body aches, nausea, pain at injection site, extreme fatigue, headache. Also on 2/8 ha...
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Fever, chills, body aches, nausea, pain at injection site, extreme fatigue, headache. Also on 2/8 had a Shingles rash for which I consulted a dr and was treated
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| 61 | 2021-03-02 | decreased appetite |
mild persistent headache all symptoms are mild flush...
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mild persistent headache all symptoms are mild flushed face tired lack of appetite/ food tastes different rash
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| 61 | 2021-03-02 | nausea |
First headache, vertigo, dizziness, nausea, neck tension, left arm weakness. Progressed in the cours...
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First headache, vertigo, dizziness, nausea, neck tension, left arm weakness. Progressed in the course of several weeks to both legs weakness, and then the right arm, tension in the jaw and the face (altered facial sensation). Poor balance. Symptoms continue getting worse. Unable to work.
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| 61 | 2021-03-04 | abdominal pain upper |
Pt s/sx started at 1200. Pt c/o stomach pain 4/10 on pain scale, throbbing pain in the L arm and nee...
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Pt s/sx started at 1200. Pt c/o stomach pain 4/10 on pain scale, throbbing pain in the L arm and needing to vomit. Pt denied chest pain, difficulty breathing, and difficulty swallowing. Pt denied any similar reaction to vaccines. Pt stated that she had not eaten anything that day. Pt was offered EMS. Pt refused EMS. Pt was offered an adult dose of diphenhydramine. Pt agreed to take medication. First dose administered at 1222 by RN, second dose administered by RN at 1223. Pt stated at 1250 "I feel like I need to puke." Pt was offered EMS for a second time. Pt refused EMS. Pt left vaccination site with son at 1305 with a steady gait.
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| 61 | 2021-03-04 | vomiting, diarrhea |
still have sore muscles in my shoulders; still feeling bad with all the above symtoms; 23Jan2021 wen...
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still have sore muscles in my shoulders; still feeling bad with all the above symtoms; 23Jan2021 went to get covid test but due to blood in my nose received antibody test which was neg; bad headache; winded; vomited; diaherra; coughing/cough; large clots gushed from my rt nostril went to er stopped bleeding after 2 hrs; large clots gushed from my rt nostril went to er stopped bleeding after 2 hrs; This is a spontaneous report from a contactable other hcp (patient). A 61-year-old female patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283, expiry date not reported), via an unspecified route of administration on the left arm on 20Jan2021 18:45 at single dose for COVID-19 immunization. Medical history included diabetes mellitus and high BP from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine, losartan potassium and sodium fluoride (CREST CAVITY PROTECTION). The patient previously took septra and experienced allergies. The patient reported that on 21Jan2021, they woke up and brushed their teeth then at 6:40am blood with large clots gushed from their right (rt) nostril. The patient went to ER and stopped bleeding after 2 hrs. On 22Jan2021, the patient woke up with bad headache, winded, vomited, diaherra (as reported), coughing. On 23Jan2021, they went to get covid test but due to blood in their nose, they received antibody test which was negative. On 24Jan2021, the patient was still feeling bad with all the above symptoms. Then on 25Jan2021, they went to ENT doctor who cauterized their nose and stated that since antibody was negative to take the maderna vaccine since they have no antibody in their system, the Pfizer vaccine did not work. From 26Jan2021 to 13Feb2021, the patient felt same started feeling better 14Feb2021 but still have sore muscles in their shoulders and cough. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 23Jan2021. The action taken in response to the event(s) for bnt162b2 was not applicable. Therapeutic measures were taken as a result of epistaxis and clot blood which include the doctor cauterized their nose. The patient recovered with sequel from the events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the epistaxis and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including CBC and coagulation panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 61 | 2021-03-06 | abdominal pain |
I have neuropathy symptoms, sore joints and muscles believed due to Tacrolimus. I see a neurologist ...
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I have neuropathy symptoms, sore joints and muscles believed due to Tacrolimus. I see a neurologist later this month. Following the first Covid vaccine, these symptoms increased. I was unsure whether this increase was due to the vaccine. However, following the second vaccine, my symptoms increased again and are substantially more severe than they were prior to the vaccine. I am also having increased pain in the area of my liver following both doses.
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| 61 | 2021-03-06 | nausea | Chills, fatigue, nausea, body aches, headache |
| 61 | 2021-03-07 | nausea |
Exhausted; Chills; Aches; Fever 100.8; Nausea; This is a spontaneous report from a contactable nurse...
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Exhausted; Chills; Aches; Fever 100.8; Nausea; This is a spontaneous report from a contactable nurse (patient). This 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EN5318) via an unspecified route of administration in the left arm on 26Jan2021 at 14:00 (at the age of 61-year-old) at single dose for COVID-19 immunisation. The patient was not pregnant. Relevant medical history included hypertension and Hashimoto's disease; the patient was allergic to sulfa and penicillin. Concomitant medications included enalapril, sertraline, lansoprazole (PREVACID) and rosuvastatin. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL0140) on 05Jan2021 at 12:15 in the left arm. On 26Jan2021 at 15:00, the patient experienced exhausted, chills, aches, fever 100.8 and nausea. All the events were considered as non-serious. Corrective treatments taken as a result of the events included paracetamol (TYLENOL) and she went to bed-slept for 14 hours straight. The patient recovered from the events on an unspecified date. The patient had not COVID-19 prior to vaccination and she was not tested for COVID-19 post vaccination.
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| 61 | 2021-03-07 | vomiting, nausea | Seven hours of nausea and vomiting. Also head ache. |
| 61 | 2021-03-08 | nausea |
I felt a shooting pain immediately from my arm into my shoulder area, and then felt itching and had ...
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I felt a shooting pain immediately from my arm into my shoulder area, and then felt itching and had a slight rash on chest area. When checked to be released, upon mentioning the rash, they checked my blood pressure, which is normally in the 90-100/68-70 range (low!) and it was 138/80. Sounds normal, but I?ve never had a blood pressure reading that high! I felt ok enough to leave with my husband, but later got dizzy, nauseous and throughout the day my joints (neck, shoulders, arms and legs) got increasingly painful, to the point where I could barely climb the stairs that night without assistance. Note: I run 5K every other day and bike or walk on off days, so I?m pretty active. I took Tylenol and went to bed early and was stiff, but better the next morning. Made myself get outside for a light run and was basically fine (albeit very tired) the next day. First day was a little scary though.
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| 61 | 2021-03-08 | nausea |
Tiredness, fatigue, headache, nausea, chills, fever. Starting about 9:PM on 02/27/21 continuing all ...
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Tiredness, fatigue, headache, nausea, chills, fever. Starting about 9:PM on 02/27/21 continuing all the next day 02/28/21. Still had a slight headache on 03/01/21.
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| 61 | 2021-03-08 | nausea | nausea, headache |
| 61 | 2021-03-10 | diarrhea |
I had to run for the bathroom with sudden-onset diarrhea. No cramps, not much pain to speak of--just...
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I had to run for the bathroom with sudden-onset diarrhea. No cramps, not much pain to speak of--just a little. My intestines have cleaned themselves OUT beginning last night and continuing to today (noon). I will be feeling nothing and then suddenly--have to RUN for the bathroom, and don't be late.
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| 61 | 2021-03-10 | nausea |
I am on infusion for severe psoriatic arthritis, and was doing well. Two days after injection it was...
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I am on infusion for severe psoriatic arthritis, and was doing well. Two days after injection it was as if the effects of my infusions were cancelled. Extreme widespread stiffness, pain, joint swelling and heat, muscle weakness and pain. I also had swollen lower lip and have had an increase in headaches and nausea. Two weeks after the injection I awoke with my right arm swollen, hard, and itchy. The arm and my lips have resolved, but I am still having all the other problems. I have reported these symptoms to both my primary doctor and my rheumatologist.
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| 61 | 2021-03-10 | vomiting |
Begin 4 days after first vaccine on 3/9/2021- First significant increase in thirst; Extreme chills ...
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Begin 4 days after first vaccine on 3/9/2021- First significant increase in thirst; Extreme chills and fever rapidly spiking to 101.5; decrease to about 100 after a few hours and held steady through early morning; decreasing to my normal (97''s) next day; Significant headache from below forward head to left and right side of neck (eustachian tubes and mandibles and lymph nodes) eye pain; vomiting (limited); leg muscle pain/. No injection site reaction 3/11 feel great
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| 61 | 2021-03-11 | decreased appetite, diarrhea |
Monday 3/08/21 after work, I was very tired and achy. I went to bed and slept 10 hours. When I eat I...
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Monday 3/08/21 after work, I was very tired and achy. I went to bed and slept 10 hours. When I eat I had diarrhea. On Tuesday, no appetite. Ate very little - crackers, and some chicken noodle soup. I had headache and chills on Tuesday evening, Wednesday and Thursday. I didn't feel well at all. Lightheaded Thursday morning, another diarrhea after a small breakfast. Called my doctor, suggested a covid test. Had a rapid covid test. It was negative. Teleconference call with my doctor on Thursday at 3pm. Nose bleed Friday morning 11:00am.
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| 61 | 2021-03-11 | diarrhea, vomiting, nausea | Shaking chills, high fever, severe body aches, nausea, diarrhea, vomiting, massive headache |
| 61 | 2021-03-11 | diarrhea |
February 25, 2021 approximately 9:30 am: Approximately 5 minutes after receiving vaccine had a stro...
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February 25, 2021 approximately 9:30 am: Approximately 5 minutes after receiving vaccine had a strong medicine taste in throat. Lasted 45 minutes - 1 hour. Approximately 9:55 am slight feeling of throat closing, which lasted about 45 minutes. Approximately 10:00 am headache, which lasted until approximately 4:00 pm, February 26, 2021. Arm soreness evening of February 25, 2021 lasted approximately 2 weeks. February 26, 2021 approximately 6:00 am diarrhea, headache, chills, legs aching, and fatigue, which lasted until until approximately 4:00 pm.
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| 61 | 2021-03-11 | nausea, vomiting |
I got my shot on March 5 and on March 9 I woke-up with super bad headache and vomited many times the...
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I got my shot on March 5 and on March 9 I woke-up with super bad headache and vomited many times the morning of the 9th. My headache pain was an 8 out of 10 from March 9 to March 11 and remained super nauseous. I got some anti nauseous medicine from the doctor. On March 12, I woke-up perfectly well. This headache and nauseousness felt like my usual reaction to soybean ingestion. I normally have a delayed reaction when I ingest soy bean. Normally, if I ingest soybean, i react 7-12 hours later. I am positive that I did not have any soybean before or after my vaccination.
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| 61 | 2021-03-11 | nausea, vomiting |
Chills, severe body aches - 11pm thru the next day, nausea - 230 am, and vomiting - 6am until 9pm,...
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Chills, severe body aches - 11pm thru the next day, nausea - 230 am, and vomiting - 6am until 9pm, fever - 530pm-939pm , headache and extreme fatigue - all day and into the next day (3/7)
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| 61 | 2021-03-11 | nausea |
Already described people - excruciating pain in my right shoulder arm & elbow causing nausea. Shot g...
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Already described people - excruciating pain in my right shoulder arm & elbow causing nausea. Shot given in left arm. I?m at home so far nothing dead or hospitalized thank you
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| 61 | 2021-03-12 | abdominal pain upper, nausea |
Received Pfizer vaccine at the Hospital on March 12, 2021 at 10:05 a.m. No reaction at that time. O...
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Received Pfizer vaccine at the Hospital on March 12, 2021 at 10:05 a.m. No reaction at that time. One hour later my ears and scalp began to itch. I had chills and severe nausea. Severe stomach cramping. Rash covering arms, legs, scalp, back and shoulders, Hives across chest and down both arms. Swelling and hives on palms of hands. Difficulty breathing. Symptoms began one hour after vaccine and continued to worsen. Was treated at Center for allergic reaction. Was given Benedryl and Famotadine, then released.
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| 61 | 2021-03-12 | diarrhea | Dark, granular diarrhea w unusual, intense odor Fever Fatigue Headache |
| 61 | 2021-03-12 | difficulty swallowing |
Pt c/o tingling in throat progressing to difficulty swallowing and mid sternal CP. Pt given 180 mg ...
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Pt c/o tingling in throat progressing to difficulty swallowing and mid sternal CP. Pt given 180 mg allegra and with in 5 minutes was feeling better. VS stable. Released to home with instructions. BP: 125/71, P=100z, Pox=97% 1215 BP=129/73, P=103, Pox=97% 1225 BP=121/66, P=82, Pox= 99%
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| 61 | 2021-03-14 | decreased appetite |
Had severe headache, chills, fever, whole body aches, joint pain, swollen arm, very hard lump and ho...
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Had severe headache, chills, fever, whole body aches, joint pain, swollen arm, very hard lump and hot at injection site. All this started the day after injection .so severe that it felt like I had covid AGAIN! Couldnt eat or hardly get out of bed the day after shot and the second day after the shot I still felt the same but was able to eat . The third day after shot, my fever went away and most of the body aches except I still have the headache and my arm is still hot, and swollen. Just have been taking tylenol this whole time and cold wash cloth for fever and swelling.
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| 61 | 2021-03-14 | diarrhea, abdominal pain |
Tacycardia and shortness of breath, followed by chills. Duration of 10 minutes until resolved. Subs...
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Tacycardia and shortness of breath, followed by chills. Duration of 10 minutes until resolved. Subsequent abdominal pain with mild diarrhea and then extreme fatigue for 5 hours. Similar to a food allergy reaction
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| 61 | 2021-03-14 | diarrhea, vomiting |
8 days after vaccine, developed burning sensation of skin which has changed locations in upper and l...
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8 days after vaccine, developed burning sensation of skin which has changed locations in upper and lower extremities. Lasts hours at a time and changes location. Also developed diarrhea, vomiting, body aches, chills 8 days after the vaccine.
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| 61 | 2021-03-14 | nausea, diarrhea, abdominal pain |
Sore left upper arm by 5pm, 3-13-21. Very tired, muscular aches whole body, chills/feverish, headach...
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Sore left upper arm by 5pm, 3-13-21. Very tired, muscular aches whole body, chills/feverish, headache overnight to present, nausea. abdominal cramping and diarrhea x 2 days. Feels like 'the flu'.
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| 61 | 2021-03-14 | nausea |
Pfizer-BioNTech COVID-19 Vaccine EUA. injection site pain, tiredness, headache, muscle pain, chills...
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Pfizer-BioNTech COVID-19 Vaccine EUA. injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, nausea, feeling unwell
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| 61 | 2021-03-14 | nausea |
Friday evening I was tired and slept a lot. When I woke up on saturday I had pain in my muscles and ...
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Friday evening I was tired and slept a lot. When I woke up on saturday I had pain in my muscles and neck and in my shoulders. I was not hungry and I had a fever(101.2). I slept until 1pm and I started getting nauseous. I never got up off the couch saturday. Pain in left arm/shoulder blade went away around 5pm Saturday. I still had a slight fever and headache saturday evening. Sunday I felt better but I still had a slight fever and headache but felt generally much better. Monday I had no fever no headache, and a little aching in my right arm at the injection site.
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| 61 | 2021-03-14 | retching, nausea |
Started to become nauseated with dry heaving, observed for 30 minutes. Vitals remained. Stable, naus...
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Started to become nauseated with dry heaving, observed for 30 minutes. Vitals remained. Stable, nausea resolved, liquid challenge.
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| 61 | 2021-03-15 | diarrhea, nausea |
nausea; chills; diarrhea; bad chest pain could barely breathe; bad chest pain could barely breathe; ...
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nausea; chills; diarrhea; bad chest pain could barely breathe; bad chest pain could barely breathe; left arm where the injection was given was very painful from the injection site to her wrist and; left arm where the injection was given was very painful from the injection site to her wrist and; can barely lift her arm over her head; increase in her blood sugar; arm pain; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9265), via an unspecified route of administration in the left arm, on 02Feb2021 14:30, at a single dose, for covid-19 immunization. Medical history included diabetes, high blood pressure, and sciatica. Concomitant medications included insulin glargine (LANTUS); metformin; hydrochlorothiazide; candesartan; glipizide (GLIPIZIDE XL) and; colecalciferol (VITAMIN D [COLECALCIFEROL]) - all taken for unspecified indications with start and stop dates not reported. The patient previously received sitagliptin (JANUVIA) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient did not have Covid prior vaccination. The patient received the vaccine in a public health clinic/veterans administration facility. The patient received the Pfizer vaccine dose 1 on 02Feb2021. The patient experienced nausea, chills, diarrhea and bad chest pain could barely breathe - these have passed. Her left arm where the injection was given was very painful from the injection site to her wrist and she has been alternating ice pack/heat pad and taking Tylenol 650 mg for the pain. She can barely lift her arm over her head. She also noticed an increase in her blood sugar and her blood was really dark - she stated this was unusual. She asked if there was anything she can do or take that might decrease her arm pain. All the adverse events happened on Feb2021 and resulted in doctor or other healthcare professional office/clinic visit. It was reported that the patient had not recovered from all the adverse events at the time of the report. No treatment was received for all the adverse events, except for "left arm where the injection was given was very painful from the injection site to her wrist" (alternating ice pack/heat pad and taking Tylenol 650 mg for the pain). The patient has not been Covid-tested post vaccination.
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| 61 | 2021-03-16 | decreased appetite, nausea, difficulty swallowing |
Within 10 min I started feeling dizzy, kind of loopy. I didn't think anything of it. I Waited 15 mi...
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Within 10 min I started feeling dizzy, kind of loopy. I didn't think anything of it. I Waited 15 min, got in my car, and felt the need to defecate. Went back in the store, completed, got in my car to drive home. Started to feel even dizzier but kept driving. Felt like maybe I was having a little bit of a strain swallowing but was breathing fine. I took 2 puffs of my Albuterol. Still felt unnatural and anxious. Got home and started to feel a little better within 15 minutes. The arm is sore, not too much of a bother, body aches. Chills for a few hours. Got up and went about my day. Tired and anxious.
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| 61 | 2021-03-16 | nausea | Nausea, tachycardia, dizziness |
| 61 | 2021-03-16 | vomiting, nausea |
woke up with nausea 36 hours after getting the shot. After vomiting I was able to go back to sleep...
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woke up with nausea 36 hours after getting the shot. After vomiting I was able to go back to sleep. The entire next day I didn't feel well. Weak, slightly nauseous. All the symptoms lasted approximately 24 hours then I was back to normal. In case it matters. I believe I had Covid last February but it was prior to public knowledge and test availability.
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| 61 | 2021-03-17 | difficulty swallowing |
C/O of difficulty to swallow saliva and throat dryness after covid -9 vaccine. Vitals taken: B/P 140...
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C/O of difficulty to swallow saliva and throat dryness after covid -9 vaccine. Vitals taken: B/P 140/80, P79, R18, Ox 98% RA Doctor checked pt's mouth, no swelling. 10 minutes after pt states "I can fee my tongue now, feel better." Pt was observe for 30 more minutes. Pt was rechecked and vitals taken: B/P 138/85, P77. Pt discharged home in stable condition.
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| 61 | 2021-03-18 | constipation, abdominal pain upper |
I had significant chills (causing strong body shaking) starting 3 hours after the shot, followed by ...
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I had significant chills (causing strong body shaking) starting 3 hours after the shot, followed by 36 hours of intermittent fever combined with chills, fever was high but not measured. I was very weak and at times was unable to get out of bed or stand. I had significant joint and overall body pain, at times unable to stand up straight. As this subsided about 36 hours I remained quite weak. On the night of 16 March I was woken up at 1 am with a very severe headache. I took Tylenol and 5 hours later still had the headache - it subsided after about 8 hours. I additionally had stomach cramping but no vomiting or diarrhea, and had no bowel movements until the episode cleared up. During the 4 days that this occurred I tried to keep well hydrated but still had quite concentrated strong urine. I took Tylenol periodically throughout the 4 days, not starting until after the injection was administered. I still feel a little loss of balance/brain fog and have recurring headaches (not migranes).
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| 61 | 2021-03-18 | diarrhea, nausea |
At about exactly 12 hours after receiving the vaccine. I was sitting in my living room watching TV a...
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At about exactly 12 hours after receiving the vaccine. I was sitting in my living room watching TV and a sudden severe pain shot through my chest and followed by tightness and difficulty breathing. It was immediately accompanied by a pain between the shoulder blades, cold sweat, nausea, then neck pain and faintness along with the uncontrollable need to move my bowels which was in diarrhea form and continued 3 times within 20 minutes with the other symptoms. After about 5 minutes of receiving the onset of the initial shocking pain, the intensity of the chest pain left but the tightness remained and faded but would return and then subside again every 10 minutes. I went to the emergency room at 11:20pm discharged at 2:50am on 3/19/21.
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| 61 | 2021-03-18 | difficulty swallowing |
My face became numb within 10 minutes of the injection. My throat started to close making it somewha...
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My face became numb within 10 minutes of the injection. My throat started to close making it somewhat difficult to swallow, but not to the point of having trouble breathing. It has been 12 hours since the injection and my face still feels numb, but swallowing is just starting to get a little easier. The numbness is mostly around my nose, cheeks and forehead.
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| 61 | 2021-03-18 | burping, flatulence |
Patient felt gassy with chest pain. History of GERD. Burping a lot during the sensation. Some reprod...
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Patient felt gassy with chest pain. History of GERD. Burping a lot during the sensation. Some reproducible L sided chest pain likely radiating from the vaccine site.
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| 61 | 2021-03-18 | nausea |
Extreme dizziness, nausea, mild pain all over body. Tome Meclizine, 25, 2 pil,, 3 p.m. Advil 7p.m....
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Extreme dizziness, nausea, mild pain all over body. Tome Meclizine, 25, 2 pil,, 3 p.m. Advil 7p.m. 200 mg Some relief by 12p.m.march 19, 2021 Still dizziness, mild pain, cloudy thinking, not able to function
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| 61 | 2021-03-19 | nausea | Dizziness and nausea caused by dizziness |
| 61 | 2021-03-19 | nausea |
I have been sick for 9 days and today I have a terrible headache to accompany the flu like symptoms....
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I have been sick for 9 days and today I have a terrible headache to accompany the flu like symptoms. Everything hurts I am nauseous and exhausted my body feels really heavy
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| 61 | 2021-03-19 | nausea |
patient experienced burning sensation, nauseous, weakness few minutes (around 5-10mins.) after recei...
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patient experienced burning sensation, nauseous, weakness few minutes (around 5-10mins.) after receiving shot while seated and in waiting observation area.
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| 61 | 2021-03-19 | vomiting, nausea | Body aches Naseau and vomiting Chills Arm soreness |
| 61 | 2021-03-19 | vomiting |
Around 7 hours after the shot the left side of my neck hurt a little along with a little sore throat...
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Around 7 hours after the shot the left side of my neck hurt a little along with a little sore throat. That evening, I was really tired with body aches. That night I had deep body aches and vomited. I also had a slight headache and coughing. The worst part was the extreme body aches. I felt like I had been hit by a truck. On Saturday (shot was on Thursday), I?m better but my body is sore and I don?t have much energy.
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| 61 | 2021-03-20 | nausea |
Fever of 100.5 Severe headache Severe body aches Some nausea All lasting about 18 hours Fatigue c...
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Fever of 100.5 Severe headache Severe body aches Some nausea All lasting about 18 hours Fatigue continuing past that
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| 61 | 2021-03-20 | nausea | pain in arm, nausea, funny-dizzy type sensation |
| 61 | 2021-03-20 | nausea |
Patient stated that approx. 5mins after getting the vaccine, she felt very nauseous and had full bod...
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Patient stated that approx. 5mins after getting the vaccine, she felt very nauseous and had full body itchiness. 50mg of PO Benadryl was given prior to coming to the hospital. Patient arrived at hospital & still complained of itchiness. Pt received solumedrol & Pepcid IV.
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| 61 | 2021-03-20 | nausea |
1. Cold chills in store, had to use restroom and urinate immediately. 2. Cold chills at home, starte...
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1. Cold chills in store, had to use restroom and urinate immediately. 2. Cold chills at home, started to shiver, jaw rattling, immediately had hot tea and wrapped in blanket. 3. Nosebleed, very unusual for me, 7 am. 4. Nosebleed, severe tinnitus, nausea, had to get out of bed and get to restroom, immediate bowel movement, severe dizziness vertigo getting back to bed. Slight tinnitus day after while writing report. Still have low nausea. 5. Sore arm for 4-5 days.
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| 61 | 2021-03-21 | diarrhea, abdominal pain upper |
16.5 hrs after injection stomach cramping and diarrhea every 2 hrs x 3. 24 hrs after injection chill...
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16.5 hrs after injection stomach cramping and diarrhea every 2 hrs x 3. 24 hrs after injection chills, fever (99.1), joint pain, fatigue.
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| 61 | 2021-03-21 | diarrhea, abdominal pain upper |
Face Swelling, lips swelling, felt like inside of mouth was thickening. Called doctors office and s...
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Face Swelling, lips swelling, felt like inside of mouth was thickening. Called doctors office and spoke to oncall doctor. He recommended to take antihistamine. On way home -stopped at gas station and got Benadryl. Took Benadryl twice Saturday and Sunday. Had cold chills and sweating Sunday night. Stomach pain and diarrhea Monday.
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| 61 | 2021-03-21 | vomiting, diarrhea |
COULD NOT LIFT ARM, DIZZINESS WHEN LYING DOWN, SEVERE VOMITING, DIARRHEA, HEADACHE, SWEATS, CH...
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COULD NOT LIFT ARM, DIZZINESS WHEN LYING DOWN, SEVERE VOMITING, DIARRHEA, HEADACHE, SWEATS, CHILLS,
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| 61 | 2021-03-21 | vomiting |
Patient received vaccine then sat in the observation area. I was called over when she looked pale an...
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Patient received vaccine then sat in the observation area. I was called over when she looked pale and felt dizzy a few minutes after receiving the vaccine. We took her vitals and her O2 was 98%, HR 61, and BP 92/67. Her normal BP is in the 110s. No history of syncopal episodes or diabetes. Patient then became unresponsive to questions and stared off into the distance for about 10 seconds. She never lost consciousness. She proceeded to gurgle up vomit and I called 911. She became responsive again and able to converse normally, but still felt dizzy. We wheeled her to the front, and EMS arrived. She agreed to go to the hospital due to the concern for her unresponsive episode, inability to walk on her own, and living by herself.
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| 61 | 2021-03-22 | decreased appetite |
I woke up about 3am with a fever and freezing to death. I was very lethargic. As the days progressed...
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I woke up about 3am with a fever and freezing to death. I was very lethargic. As the days progressed, I became very weak and wanted to sleep all of the time. I lost my appetite, taste and smell. I was tested for COVID on 1/12 and found out I was positive the next day. I was out of work for 2 weeks and returned to work on 1/25/21. I got an infusion on 1/20 so I can't get my 2nd dose until 90 days after that date.
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| 61 | 2021-03-22 | nausea |
Immediately: headache, left eye pain, nausea, cold sensation and felt ?weird? but thought it was nor...
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Immediately: headache, left eye pain, nausea, cold sensation and felt ?weird? but thought it was normal and thought I might feel flying for a bit but that it would wear off so I did not report feeling anything at the clinic. I left the clinic and got in the car to drive home and felt a weird feeling in my throat reminiscent of my esophageal spasm and then it felt like someone had their hand on my throat squeezing my throat and felt like I needed to take deep breaths to expand my lungs. Within a minute or two at most, my lips, tip of my tongue, tip of my nose and face beside my lips and under my cheeks started to tingle and go numb. My insides felt swollen. I had a doctors appointment and went there after picking my son up at home. I reported my feeling to my doctor who prescribed a steroid for 3 days and told me to also take Benadryl or Claritin, which I did. However, today is day 4 after my vaccine and today is the first day my insides don?t hurt.
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| 61 | 2021-03-22 | nausea |
Low fever (100 F), pain at injection site, nausea and dizziness. It lasted about 12 hours. I took a...
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Low fever (100 F), pain at injection site, nausea and dizziness. It lasted about 12 hours. I took a Tylenol when nausea subsided (in the afternoon).
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| 61 | 2021-03-23 | diarrhea, abdominal pain upper | dizziness, fatigue, severe stomach cramps and diarrhea, muscle aches 8 days running |
| 61 | 2021-03-23 | nausea |
Fainting, fever, chills, nausea. Had repeated fainting spells the morning after the day I was vacci...
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Fainting, fever, chills, nausea. Had repeated fainting spells the morning after the day I was vaccinated. Felt better the next day, still had slight fever. By Wednesday (third day after vaccine day), felt fine. The reason I am reporting this is the fainting episodes. I do not see that online as a listed common side effect of the vaccine.
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| 61 | 2021-03-23 | nausea |
Got hot, felt nauseated, fast heart rate and a little light headed and dizzy I also did not eat bef...
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Got hot, felt nauseated, fast heart rate and a little light headed and dizzy I also did not eat before i got the shot they seem to think my sugar dropped as soon as i had something to eat and drink i was fine
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| 61 | 2021-03-23 | nausea |
started with slight headache early in the morning. I attributed this to pollen and allergies. It l...
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started with slight headache early in the morning. I attributed this to pollen and allergies. It last most of day. Then at 4:30 my head began to pound. I felt dizzy and extremely nauseous. This lasted about 4 hours and then I felt much better.
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| 61 | 2021-03-24 | abdominal pain upper, abdominal pain, abdominal distension, diarrhea |
Abdominal pain extreme bloating some upper abdominal pain off and on for six days. Went to dr recomm...
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Abdominal pain extreme bloating some upper abdominal pain off and on for six days. Went to dr recommended gasx pepto bismol loose stools six days
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| 61 | 2021-03-24 | constipation, GERD, abdominal pain upper, nausea |
Diabetes; unable to concentrate; arm is killing her; hands are swelled up; constipated; nausea; tigh...
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Diabetes; unable to concentrate; arm is killing her; hands are swelled up; constipated; nausea; tightening of chest every so often; acid reflux; hot flashes; sweating; stomach aches; upper abdominal pain radiating to back; severe fatigue; Dizzy/dizziness; stomach feels odd; Headaches; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EN6198), via an unspecified route of administration, administered in upper left arm on 25Feb2021 9:00 (at the age of 61-year-old) as single dose for virus (COVID-19 immunisation). Medical history included chronic pain, pancreatitis, allergic to medications, old injury in her right arm, menopause and an ongoing mass in parotid lobe discovered in 2019 with CT scan. MRI performed in Mar2020 and CT scan in Oct2020. She stated that they are just watching it because it has not changed. Well defined borders are present, caller stated that doctor was unconcerned. Her mother had heart disease. Ongoing concomitant medications included ibuprofen for chronic pain and gabapentin from 2019 for chronic pain. The patient also took unspecified medication for pancreatitis. She has taken all kinds of stuff after pancreatitis but they do not work. The patient got deadly ill from the flu shot. Unsure of onset age, vaccine/brand name, or vaccination date. She stated that it was before 2003, possibly in the late 1990's or early 2000's. The patient had no history of all previous immunization with the Pfizer vaccine and no additional vaccines administered on same date of the Pfizer suspect. On unspecified date the patient experienced diabetes; on 25Feb2021, the patient experienced dizzy, stomach feels odd, hot flashes, severe fatigue, sweating, stomach aches, acid reflux, upper abdominal pain radiating to back; on 26Feb2021 she experienced tightening of chest every so often; and in Feb2021, she had headache. It was further reported as follows: The patient stated that she took the Pfizer shot, clarified that she received the Covid-19 vaccine, on 25Feb2021, not quite 2 weeks ago. She stated that she had a little bit of a reaction after receiving the vaccination while there, so they were monitoring her. She has been experiencing hot flashes, sweating, and stomach aches for 2 days. She cannot get rid of hot flashes and that she has not had a hot flash in 2 years. She states that she has been down for 2 days with fatigue, that it's really bad. She is inquiring if the side effects that she is experiencing are common side effects and if it is ok to get 2nd shot. Her second vaccine is scheduled for 17Mar2021. She stated that she wanted to take the time to make a report as she is allergic to medications. While inquiring about dates of vaccines and side effects, she stated that she was experiencing tightening of chest every so often. She stated that she only had a few days of stomach pain and she has not stopped eating. She is unable to concentrate (unspecified date) and she has been experiencing headaches, experiencing them twice in 2 weeks. She also reported that she has been having upper abdominal pain radiating to her back. This concerns her, every time she gets it, it scares her. She had pancreatitis when she was 36. It is a nightmare thought. Does this sound like maybe she is possibly starting Diabetes? She reported that this shot has triggered everything. She has an old injury in her right arm. Her arm is killing her, her hands are swelled up, she has acid reflux again, she felt terrible. She stated that the dizziness not as strong as it was at the beginning. The fatigue it comes and goes and that she has spurts where she is energetic. She stated that it's more on than off. She is no longer having stomach aches. She compared the pain to pains of constipation. She also stated that she was constipated after receiving the vaccine on unspecified date. She had nausea at the beginning. The tightening of chest happened off and on, the last day that she experienced tightening of chest was on Sunday. For acid reflux, she is taking Zegerid as treatment, 20mg 20 mg capsules by mouth once daily as needed. She started this on 02Mar2021. She experienced upper abdominal pain yesterday and some this morning, but it was mostly in her back this morning. Her Sweating is off and on. She experienced headache just a couple of times but that she has not had one in a while. She stated that they lasted only an hour or two, and that she does not usually get headaches. She suggested that these may be due to sinuses and weather change. She has been taking Ibuprofen twice a day as treatment. But she normally takes Ibuprofen for chronic pain. Supposed to be 3 times a day but she does not want to take that much. She stated that all of this could also be stress related and that this could also be menopause. The patient recovered from stomach aches on 02Mar2021. The outcome of the events dizzy, sweating, tightening of chest every so often, upper abdominal pain radiating to back, headache was recovering; the outcome of stomach feels odd, hot flashes, severe fatigue, acid reflux was not recovered. The outcome of the remaining events was unknown.
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| 61 | 2021-03-24 | decreased appetite |
minimal chronic portal inflammation ( lymphs, rare eos, some neutrophils, no plasma cells seen); ext...
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minimal chronic portal inflammation ( lymphs, rare eos, some neutrophils, no plasma cells seen); extensive cholestasis; symptoms of mild decrease appetite; some fatigue; This is a spontaneous report from a contactable Physician. A 61-Year-Old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 19Jan2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included hemiparesis, hypertension, hyperlipidemia, recurrent UTI. Concomitant medications included AMLODIPINE BESILATE, calcium carbonate, colecalciferol (CALCIUM + VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]) for UTI, cefalexin KEFLEX [CEFALEXIN] and nitrofurantoin for UTI. The patient received first dose of BNT162B2 on 29Dec2020. On 02Feb2021 the patient experienced minimal chronic portal inflammation, symptoms of mild decrease appetite, some fatigue and extensive cholestasis. Serologic workup was notable only for ASMA 1:160, including extensive viral and immune workup Liver performed on 24Feb2021: extensive cholestasis, normal reticulin and trichrome stains, minimal chronic portal inflammation; no lobular or interface activity. The patient underwent Sars Cov2 test on 22Feb2021 which resulted negative. At the time of the reporting the patient was recovering from the events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Hepatitis, cholestasis and other events due to temporal relationship . Additional information is needed to better assess the case, including complete medical history, diagnostics including liver function tests/hepatic enzymes prior to subject drug therapy and during subject drug therapy, abdominal ultrasound, CT/MRI of abdomen, viral hepatitis serology, serum bilirubin, serum alkaline phosphatase, counteractive treatment measures and concomitant medications. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 61 | 2021-03-24 | diarrhea |
On 3/22/21 I experienced several bouts of diarrhea coupled with clammyness/sweating/heart rate of 10...
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On 3/22/21 I experienced several bouts of diarrhea coupled with clammyness/sweating/heart rate of 102. On 3/22/21 and continue to have swelling in my left armpit (Lymph node area), spasms in my left shoulder blade and surrounding soft tissue adjacent to my left armpit and neck area. I have experienced soreness in that arm/shoulder but not at the injection site - overall bicep and clavicle area. I have been able to alleviate symptoms to a degree by taking a tylenol once or twice a day but the pain is limiting some of my daily activities to a degree.
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| 61 | 2021-03-24 | difficulty swallowing |
Throat tightness with difficulty swallowing, tingling to face and head. Lasted approx 10-15 seconds....
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Throat tightness with difficulty swallowing, tingling to face and head. Lasted approx 10-15 seconds. Went to the emergency room and was stable at the time. Toward the latter part of the ER visit, I was given prednisone, Pepcid, and Benadryl. Have had no issues since then.
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| 61 | 2021-03-24 | difficulty swallowing |
Within 15 minutes following her COVID vaccine with concerns for a lump in her throat. She states she...
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Within 15 minutes following her COVID vaccine with concerns for a lump in her throat. She states she is able to swallow without difficulty. She denies any shortness of breath, chest pain, nausea, rash, or any other symptoms. Benadryl 25 mg given. Continued to monitor and improved
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| 61 | 2021-03-24 | vomiting |
Directly after getting the shot I was sleeping harder than I ever have for about 14 days then on Mar...
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Directly after getting the shot I was sleeping harder than I ever have for about 14 days then on March 4 woke up after a very deep sleep tired the next day the same thing March 5 woke up extremely fatigued March 6 same thing woke up extremely fatigued and after going for a short bike ride started getting an intense headache, set up got very dizzy, then proceeded to throw up harder than I ever have and so debilitatingly that I had to call the paramedics and they took me to the emergency room. The ER doc at first said that this could not be an adverse effect 14 days later of the first Covid shot, but then he said he didn?t know, for the next nine days I did not leave my house I was so exhausted. I am an athlete and exercise every day have tons of energy all day long and have never felt this way before. I then met with my regular Doctor Who ordered tests of different varieties everything came back normal and to this day which is now March 25 I have extreme fatigue and I can barely work. Like I said above I am an athlete I run five days a week ride my bike two days a week and swim generally two or three days a week and work as a teacher and I can barely do any of that.
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| 61 | 2021-03-25 | difficulty swallowing | Swelling of throat, getting harder to swallow. Vitals wnl. Given Benadryl 25 mg PO. |
| 61 | 2021-03-25 | vomiting, nausea | syncope, n/v |
| 61 | 2021-03-25 | vomiting, nausea |
Began with waves of prickly hot sweats, light headed dizziness, cold chills, nausea. Got progressive...
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Began with waves of prickly hot sweats, light headed dizziness, cold chills, nausea. Got progressively worse-was at dentist, sent home, could not walk unaided (dizzy). Threw up in car on way home. Spent evening with these sympyoms gradually decreasing in strength, very fatigued, took effort yo breathe. Also soreness of arm. Next day: very fatigued, sore arm, but test of symptoms passed (little nausea, but not bad)
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| 61 | 2021-03-26 | nausea, diarrhea, vomiting |
weak, cold, throwing up, hot flashes, dizziness, head hurt, sweating in sleep, diarrhea , body pain,...
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weak, cold, throwing up, hot flashes, dizziness, head hurt, sweating in sleep, diarrhea , body pain, nausea
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| 61 | 2021-03-26 | nausea |
Traffic personnel brought patient back to observation room after c/o nausea that started at 1030 am....
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Traffic personnel brought patient back to observation room after c/o nausea that started at 1030 am. Patient reported no adverse after her 15 minute observation period Vital signs at 10140 am 163/86 56 28 99% O2 sat on room air She reported a history of anxiety. Given cold compresses and water. Symptoms resovlved and she left. Given instructions to call 911 or her PCP as needed. Ambulated out without difficulty. She left with her husband at 1055 am.
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| 61 | 2021-03-27 | abdominal discomfort, abdominal distension |
at 3am I woke up with a racing heart rate and mild burning in my belly. I couldnt go back to sleep. ...
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at 3am I woke up with a racing heart rate and mild burning in my belly. I couldnt go back to sleep. The next day the burning in the belly got worse. My stomach became bloated and I was having shortness of breath walking short distances. The racing heart and chest pain ebbed and flowed. I made a video appointment with my PCP group on Thursday and they prescribed omeprazole and asked me to come in for physical exam the next day. When I went in the symptoms persisted, they did blood work, did a chest x-ray and sent me over to the emergency room. At the ER they did an EKG, more blood tests and recommended I have a abdominal CT on an outpatient basis. They couldnt say my symptoms were a result of the Pfizer shot but they could not rule it out that it was related to the shot.
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| 61 | 2021-03-27 | abdominal pain upper | Both arms feeling like on fire. Headache, body aches, stomach ache, throat feels tight |
| 61 | 2021-03-27 | decreased appetite |
Injection site pain and redness, tiredness, splitting headache, muscle ache, chills, joint pain, in...
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Injection site pain and redness, tiredness, splitting headache, muscle ache, chills, joint pain, intermittent fever, loss of appetite
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| 61 | 2021-03-27 | burping, diarrhea, abdominal pain upper, abdominal pain, vomiting |
From the afternoon of Tuesday, March 23 through early afternoon of Saturday, March 27 gastric crampi...
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From the afternoon of Tuesday, March 23 through early afternoon of Saturday, March 27 gastric cramping, explosive diaherra, stomach pains, vomiting, and belching. The stomach pains were the worst in the first 36 hours, the gastric cramping gradually lessened over four days. Vomiting was confined to the mornings of March 24 and March 25. The explosive diaherra happened every two hours for the entire period. Small sips of water, diluted apple juice, peppermint tea all resulted in increased gastric cramping. The first food (two scrambled eggs) I was able to eat was on Friday morning, March 26.
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| 61 | 2021-03-27 | nausea, diarrhea |
3/11-3/12/21 - heart palpitations, start of flu symptoms 3/13-3/18/21 - heart palpitations and high ...
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3/11-3/12/21 - heart palpitations, start of flu symptoms 3/13-3/18/21 - heart palpitations and high heart rate, blood pressure high and low, chills, weak, diarrhea, nausea, headache 3/19-3/23/21 - heart issues better, still had flu symptoms Propanolol and Alprazolam for heart palpitations. ER visit 3/16 - recv IV's, all labs normal. PCP visit 3/23.
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| 61 | 2021-03-27 | nausea, diarrhea |
Chills, fever 101.6F, headache, fatigue, nausea, diarrhea. Today she states she is feeling a little ...
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Chills, fever 101.6F, headache, fatigue, nausea, diarrhea. Today she states she is feeling a little better but is still a little nauseated and fatigued. She states she's been taking Tylenol off and on.
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| 61 | 2021-03-27 | nausea | Tinnitus with slight dizziness and nausea |
| 61 | 2021-03-27 | vomiting, nausea, decreased appetite |
total of 4 days tired/weak, and right arm sore (from thursday through sunday) early saturday morning...
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total of 4 days tired/weak, and right arm sore (from thursday through sunday) early saturday morning had 4 hours of hallucinations, nausea and extreme vomiting, dizzyness ,loss of appetite slept for 12 hours on saturday and sunday after the 4 hrs of events listed above. still weak after feeling better on sunday afternoon
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| 61 | 2021-03-29 | appendicitis | Acute perforated appendicitis that went to the OR urgently. Patient still in hospital |
| 61 | 2021-03-30 | decreased appetite, nausea |
Fatigue; Fever (101.6); Chills; Shakes; Muscle pain; Joint pain; Headache; Foggy head; Loss of appet...
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Fatigue; Fever (101.6); Chills; Shakes; Muscle pain; Joint pain; Headache; Foggy head; Loss of appetite; Nausea; Sore arm at injection site (minor); Swollen lymph gland under left arm; Dizzy; This is a spontaneous report received from a contactable nurse (reported for herself). A 61-year-old female patient received second dose of BNT162B2 (Comirnaty, Solution for injection and Lot number: EL3246), intramuscularly to left arm on 12Jan2021 10:00 at a single dose for COVID-19 Immunization. Patient medical history was reported as none. Patient concomitant medications included calcium, ergocalciferol (VITAMIN D), multivitamin and probiotic. The patient previously took BNT162B2 (Comirnaty, Lot number: EJ1685) vaccination, intramuscularly to left arm on 22Dec2020 for COVID-19 immunization. On 12Jan2021 22:00, 12 hours after the second dose of vaccination the patient experienced with fatigue, fever (101.6), chills, shakes, muscle pain, joint pain, headache, foggy head, loss of appetite, nausea, sore arm at injection site (minor), swollen lymph gland under left arm. patient was on bed and felt dizzy after fever broke for about 24 hours. Seriousness was reported as non-serious. Patient received on advil at night for treatment of events. The outcome of events was recovered on an unspecified date. No follow-up attempts are possible, No further information available
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| 61 | 2021-03-30 | diarrhea |
violent heavying, sweating for 2 hours; pain in chest; diarrhea; chills; sore; This is a spontaneous...
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violent heavying, sweating for 2 hours; pain in chest; diarrhea; chills; sore; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 06Mar2021 14:00 as a single dose (at the age of 61-years-old) for covid-19 immunisation. The patient had known allergies to flu shot, contrast dye, aspirin and codeine. She had a major reaction to flu shot so was scared to have this. She took Pepcid and Zyrtec 3 days prior and 1 week following. The patient was not pregnant at the time of vaccination. The patient had no COVID prior vaccination. There were no other vaccine in four weeks. There were other medications in two weeks. The patient received the first shot, day 1 and 2 was fine. On day 3 (09Mar2021 11:00), diarrhea started, day 4 (10Mar2021) - violent heavying, sweating for 2 hours then pain in chest. The patient thought she was having a heart attack. After many test it was not her heart, then more test that would not cause these issues. The physician determined it was the vaccine. On Mar2021, she still feel chills and very sore. The patient was scared to get her second dose. It was unknown if the patient received treatment for the reported events. The reported events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was not tested post vaccination. The outcome of the events was unknown. Information on the lot/ batch number has been requested.
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| 61 | 2021-03-30 | nausea |
chills; injection site pain; headache; muscle pain; fever/tiny fever; impacted lymph nodes/lymph nod...
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chills; injection site pain; headache; muscle pain; fever/tiny fever; impacted lymph nodes/lymph nodes are impacted a little bit; nausea/feeling nauseous; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6206) via an unspecified route of administration, administered in Arm Left (left shoulder), at the age of 61-year-old, on 03Mar2021 19:00, as SINGLE DOSE for covid-19 immunisation. The patient medical history was overweight, diagnosed COVID last Apr2020 she had it for 17 days and had every symptoms. The patient tried to give antibodies for many months and she was told she had two different kinds of antibodies which prevented her from doing that. The patient has long hauler symptoms which are nerve pain in her thighs and mouth. The patient's concomitant included an unspecified medication (she takes something but not relevant). The patient did not receive any vaccine within 4 weeks prior. The patient previously received shingles vaccine on 14Feb2020 and tetanus shot on an unspecified date (years ago) both given for immunization and her arm hurt/ pain at the injection site (if she touches it, it hurts). On 03Mar2021 at 7PM, after receiving first dose, she felt blah described as she developed injection site pain which is dissipating but still there, headache, muscle pain, tiny fever, impacted lymph nodes, nausea/ feeling nauseous which she didn't have before. The patient can get up and walk around. On 04Mar2021, the patient had chills in the afternoon. It was just a little fever. The patient took Tylenol and Advil in the afternoon and it helped it go away. The patient took one of each. It was reported that the COVID headache is like none other and she had the headache again. For the COVID headache if you take things it doesn't make it go away. When the patient said she had the headache again she meant she had the same headache that she had in April. The events did not require ER or physician office visit. Outcome of injection site pain was not recovered while it was unknown for the other events. The reporter assessed the events as non-serious. Information on the lot/batch number has been requested.
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| 61 | 2021-03-30 | nausea |
Body aches; Sore injection site; Nausea; This is a spontaneous report from a contactable consumer. A...
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Body aches; Sore injection site; Nausea; This is a spontaneous report from a contactable consumer. A 61-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EL9269), via an unspecified route of administration, administered in Arm Right on 09Feb2021 15:30 as Single Dose for covid-19 immunisation. Medical history included drug hypersensitivity (Sulfa allergy), thyroid disorder and hypertension from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine, liothyronine (NP THYROID) from unspecified date to unspecified date for unknown indication. On 09Feb2021 23:00, The patient experienced body aches, sore injection site and nausea. The action taken in response to the events for BNT162B2 was not applicable. Outcome of events was not recovered.
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| 61 | 2021-03-31 | vomiting |
received second dose of vaccine on 3/30. On 3/31 presents via EMS due to altered mental status and v...
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received second dose of vaccine on 3/30. On 3/31 presents via EMS due to altered mental status and vomiting. EMS reports that she was found sitting in her van lethargic and actively vomiting. When EMS arrived they noticed that the patient had her fingers in her throat trying to induce vomiting. EMS reports EKG in sinus rhythm with HR 84, BP 178/106, and O2 sat 99% on RA. EMS did not notice focal weakness. Pt c/o HA and is noted on arrival to not be moving her LUE. I spoke with her daughter, who said she spoke to the pt on the phone at 10:45 am today and that she seemed normal at that time. She reports the pt does not have h/o cancer or heart disease and is unaware of any pt medication allergies. She reportedly received her COVID vaccine yesterday.
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| 61 | 2021-04-01 | abdominal pain |
Severe abdominal pain, leading to ER visit and diagnosed with Pancreatitis. Severe pain started 30 m...
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Severe abdominal pain, leading to ER visit and diagnosed with Pancreatitis. Severe pain started 30 minutes after the vaccination.
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| 61 | 2021-04-06 | abdominal pain upper |
Severe stomach pain ; hospitalized in emergency; patient received the first dose of BNT162B2 (PFIZER...
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Severe stomach pain ; hospitalized in emergency; patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via subcutaneous; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via subcutaneous at age of 61 years, at single dose in left arm on 01Apr2021 at 11:15 (Lot number: ER8734) for COVID-19 immunisation. Medical history was not provided. The patient had no allergies to medications, food, or other products. Concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient experienced severe stomach pain on 01Apr2021 at 11:15 and hospitalized in emergency for it. And it was reported that the adverse event result in "Emergency room/department or urgent care" and it was unknown if treatment received for the adverse event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and she was not diagnosed with COVID-19 prior to vaccination or since the vaccination. Event outcome for severe stomach pain was not recovered.
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| 61 | 2021-04-09 | nausea |
not sure if she has Covid; not sure if she has Covid; she got sick; queasy stomach; hurting of her a...
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not sure if she has Covid; not sure if she has Covid; she got sick; queasy stomach; hurting of her arm that she got the vaccine in; This is a spontaneous report received from a contactable consumer (Patient). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 03Mar2021 13:00 (Batch/Lot Number: EN6206) at the age of 61-years-old as single dose for covid-19 immunisation. The COVID-19 vaccine was administered in parking lot. Not at Military Facility. The patient's medical history reported as none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historic vaccine included 23 years ago with her 1st flu shot she got sick but has not had any issues since. Patient stated she was scheduled for the 2nd Pfizer shot today and she got sick and was not sure if she has Covid on 23Mar2021. Stated she didn't want to get the 2nd shot and exacerbate her symptoms, states she got symptoms with her first shot. Patient was wondering if she can reschedule her shot in general as it was scheduled for today. Patient stated the symptoms after the 1st shot were not detrimental, she had a queasy stomach later that night and natural hurting of her arm that she got the vaccine in. Stated it started that night after 12 at night. Clarified she got the shot 03Mar2021 and the symptoms started after midnight making it 04Mar2021. Stated the symptoms didn't even last 24 hours and were gone by 05Mar2021. No Emergency Room and No Physician Office visit required. The outcome of the events 'hurting of her arm' and 'queasy stomach' was recovered on 05Mar2021 and the outcome of the events was unknown.
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| 61 | 2021-04-11 | nausea | Nausea, vital signs stable, left in stable condition |
| 61 | 2021-04-13 | nausea |
Within 1 hour severe side effects: body aches, cough (dry like asthma) , fatigue, dizziness, chills...
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Within 1 hour severe side effects: body aches, cough (dry like asthma) , fatigue, dizziness, chills, nausea, could not sleep, Swelling, warmth, burning swellinge first dose size of 1/2 orange. No fever. Second not as severe as the first. Body aches, muscle pain, dizziness, chills, nausea, painful injection site not as much swelling,No fever. Blood Sugar spikes: 1/31/2021 280, 2/1/21 2112/27/21 319, 2/28/21 418. 9 days after second vaccine. Purple swelling of both feet. cellulitis rt foot pain worse in lt than rt .PCP to ER (soles, top lower legs black): susp tibial artery occlusion lt . Heparin. Farxiga, Ultram, baby aspirin, procardia, metformin.Possible Reynauds.Still pain discoloration and swelling.
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| 61 | 2021-04-14 | abdominal pain upper, diarrhea | dizzy, weak, stomach pain, loose bowel movements, confusion, heart palpitations |
| 61 | 2021-04-14 | difficulty swallowing |
At approx. 9:22 AM on 4/2/21, I began having problems swallowing my saliva and felt my throat begin ...
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At approx. 9:22 AM on 4/2/21, I began having problems swallowing my saliva and felt my throat begin to close. I also began having problems breathing, began coughing and choking, chest pain, and dizziness. The nursing staff at Hospital immediately got a wheelchair and rushed me next door to the ER. The nurses had called ahead so that the ER doctors were ready to assist me. I was given Epinephrine, steroids, nubilizer treatments, Bendryl, IV fluids and oxygen. After some time I began feeling a little better but then the reaction restarted and treatments had to be re-administered several times. It was quite frightening. I also had a severe headache and tightness of the chest . The ER doctor believed that I should be admitted which was done on 4/2/21 and was kept thru 4/4/21.
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| 61 | 2021-04-17 | abdominal pain upper, decreased appetite |
dizziness; headache; fever; stomach cramps; migraine; no appetite; dry cough; fainting; stomachache;...
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dizziness; headache; fever; stomach cramps; migraine; no appetite; dry cough; fainting; stomachache; This is a spontaneous report received from a contactable consumer (patient). A non-pregnant 61-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 61 years old, administered in arm left on 23Mar2021 19:15 (Lot Number: EN6207) at single dose for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis, arthrosis, osteoporosis, due to arthritis the patient couldn't eat pork because her joints get swollen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included etanercept (ENBREL); methotrexate sodium (METHOTREXAAT). The patient experienced fainting, stomachache, stomach cramps, migraine, no appetite, dry cough on 24Mar2021 15:30, dizziness, headache, fever on 25Mar2021. The patient stopped using Enbrel and taking Methotrexate a few days prior Pfizer's vaccine. Next day on 24Mar2021, the patient had stomachache, 3rd day (25Mar2021) started with dizziness, headache and fever. Symptoms kept going after 10 days. 5 days later the patient went to the hospital and was prescribed something for stomach cramps and migraine. But the fever continued. 3 days later doctor prescribed an antibiotic since she didn't know the reason of the fever. During the course of the fever the patient had been taking Tylenol on daily basis. Fever came and went and the patient had no appetite and keep with fainting. Doctor ordered lung rx but the patient couldn't do it. 10 days later the patient had dry cough (event onset date was also reported as 24Mar2021, 15:30). The same symptoms remained. The patient did not receive treatment for all events (except fever). Events resulted in Emergency room/department or urgent care and Doctor or other healthcare professional office/clinic visit. The outcome of the all events was reported as not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
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| 61 | 2021-04-17 | constipation, burping, abdominal distension, nausea, diarrhea |
My heart flutters; heart spasms; uncalm coming into my dreams viciously, morbidly gross; super water...
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My heart flutters; heart spasms; uncalm coming into my dreams viciously, morbidly gross; super watery bowel movement then went into clay like and drier consistency but still dark (I never had stool this dark).; I was dry/ I needed water; room seemed like it was so much further away, my stairs the spindles were larger in size, it was if I was high on something/feeling of peace, calm/high feeling; I was whistling in my breathing/ I had a loud whistle; feeling my eyes and hearing were sharp/ my eyes were changed eventually; had my eyes dilated; felt I like I was getting hemorrhoids/I woke up feeling like I had too much sugar; black stool; constipation; Chills; wanted to vomit; I got shaky; scares; There's a feeling of hardness in my lower abdomen and heart area (Belch); There's a feeling of hardness in my lower abdomen and heart area (Belch); reversed my beta blockers (it keeps it in the 50s) it went to 79; My energy was so much more.; The next day I gained 3.2 pounds then the next day lost 3 pounds; My injection site for the first 2 weeks,I had an itch/ extreme itch; injection site for the first 2 week/there's pain there on touch (no throbbing pain); My tooth broke; movement under my skin/shingles feeling; My skin is extremely dry; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. It was reported that the patient vision wasn't as good. She also had glasses to read (eyeglass wearer and ongoing) and behind her eyes they were dry one (left) mostly. Concomitant medications included unspecified beta blockers. On 11Mar2021, she got chills on the same day. Right as she got the shot, she wanted to vomit also and got shaky. On 12Mar2021, she woke up with whistling in her breathing for a few minutes then it was done. At the same moment, her eyes were changed eventually. She had mucus in my eyes as her vision wasn't as good and behind her eyes, they were dry one eye (left). So, watching TV wasn't as good and became bothersome. She later noticed, the black in here eye was taken up most of her eye (as if her eyes were dilated). Her eyes and hearing were sharp also now sharp as she was reading better (without my read glasses) and had to turn down the volume in her TV. She also felt like she was getting hemorrhoids for a few days but then it went away. She also had black stool, then constipation (harder stool) eventually went the day right after the shot (12Mar2021). Then around 5pm, she had feeling like she had too much sugar and was dry which she needed water. Once she sat down, her living room door seemed like it was so much further away, stairs the spindles were larger in size, it was if she was high on something. It was different nothing but this injection. She was also experiencing a feeling of peace and calm. As if nothing was wrong, no stress (stressing about something) she couldn't even think of- everything was gone, a calming effect. It was high feeling. The next day (13Mar2021), she had a super watery bowel movement then went into clay like and drier consistency but still dark (she never had stool this dark). In Mar2021, she also stated that there was a movement under her skin like a pre-herpes or a pre-shingles. She mentioned that she knew herpes and the movement under her skin was shingles feeling. Her skin was also extremely dry. On 17Mar2021 (a week after the injection), she woke up to my heart spasm. It was beating real fast (beating like right under her skin), no pain and heart attack but more than a heart flutter. She didn't know whether it was going to beat or stop. She also woke up with a loud whistle (louder than before) out of a dream. She stated that during the day she doesn't get the stressed, but in her dream, it was magnified and woke up in a violent vicious fury. She had 3 nights of this (uncalm coming into my dreams viciously, morbidly gross) started on 14Mar2021. The heart spasms come as a few seconds and goes away but that's happened twice which it scares her. She also stated that there was feeling of hardness in her lower abdomen and heart area (belch) in Mar2021. The injection almost reversed her beta blockers (which keep it in the 50s) it went to 79 (same as it was before she started taking beta blockers) but her blood pressure was normal 121/something (that was a good thing). She also mentioned that her energy was so much more while other people woke up early, cleaning up -would get sleepy and a little tired. But this (injection) gave her energy. Her injection site for the first 2 weeks also had an itch, that would come up (not constant) almost like a yeast infection which had an extreme itch. There's pain was there on touch (no throbbing pain) it took over a week before it was gone. She also mentioned that the chills were off and on for 4 days. The vaccine also did something to her weight as she was expecting to lose weight, but she didn't. One day, she gained 3.2 pounds then the next day lost 3 pounds. Her tooth also broke (but no pain in her tooth) even she had a sensation of her teeth being weak which she could feel it. Her tooth broke eating a tortilla chip and that's weird. She wanted to know if other people had called in with the symptoms that she had experienced. The patient recovered from breath sounds abnormal and constipation on 12Mar2021; cardiospasm, chills and vaccination site pain in Mar2021 while the remaining events were unknown. No follow-up attempts are possible. Information on the lot/batch number cannot be obtained.
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| 61 | 2021-04-18 | nausea |
having a stroke; I began to experience numbness on my entire left side, left arm; hand weakness, lef...
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having a stroke; I began to experience numbness on my entire left side, left arm; hand weakness, left leg weakness; trouble walking/stumbling; speech problems; slurred speech; fatigue; injection site pain; nausea; pain in my left hip; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8727), via an unspecified route of administration, administered in left arm on 29Mar2021 16:30 at single dose for COVID-19 immunisation. The patient's medical history included chronic fatigue syndrome, fibromyalgia, sulfa allergy. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was Pharmacy/drug store. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient experienced immediate fatigue, injection site pain, nausea, along with pain in her left hip the day after her first Covid vaccine on 30Mar2021 05:00 (Tuesday). The injection site pain resolved after a few days, but she continued to be exhausted and nauseous all week. On 02Apr2021 (Friday), she began to experience numbness on my entire left side, left arm and hand weakness, left leg weakness, trouble walking, speech problems, having to really think about her words (her daughter-in-law was typing this as she could not), slurred speech, stumbling. Her family was concerned she was having a stroke on 02Apr2021 05:00, but have no drooping in her face. She was so scared that she will not be getting her second vaccine. She have not gone to a doctor, as she do not have insurance. The symptoms were continuing. No treatment was received for the adverse events. The outcome of the event 'injection site pain' was recovered; the events fatigue and nausea was not recovered; and unknown for the rest of the events. Events were reported as non-serious. Information on lot/batch number was available. Additional information has been requested.
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| 61 | 2021-04-18 | nausea |
tachycardia (avg. 125 bpm); dry mouth; low sodium; low potassium; excruciating headache with light a...
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tachycardia (avg. 125 bpm); dry mouth; low sodium; low potassium; excruciating headache with light and sound sensitivity/head pounding; light and sound sensitivity; light and sound sensitivity; nausea; lightheadedness; My arm was sore; Felt absolutely terrible; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8734), via an unspecified route of administration, administered in left arm on 01Apr2021 13:30 (1:30 pm) as single dose for COVID-19 immunization in a clinic. Medical history included autoimmune hypothyroidism, gastrooesophageal reflux disease and don't tolerate NSAIDs but not allergic all from an unknown date. Concomitant medications included levothyroxine; esomeprazole magnesium (NEXIUM); cetirizine hydrochloride (ZYRTEC ALLERGY); gabapentin; and estradiol (ESTROGEL) all taken for an unspecified indication, start and stop date were not reported. The patient previously took erythromicin and experienced drug intolerance but not allergic on an unspecified date. The patient previously received the first dose of bnt162b2 (lot number: EN6204) on 11Mar2021 1:30 pm administered in left arm for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested since the vaccination. On 01Apr2021, it was reported that the patient experienced tachycardia (avg. 125 bpm), dry mouth, low sodium, low potassium, excruciating headache/head pounding, light and sound sensitivity, nausea, lightheadedness, arm was sore, and felt absolutely terrible. The patient was hospitalized for tachycardia (avg. 125 bpm) for 1 day. The events required physician office and emergency room visit. the patient was treated with IV saline, IV anti-nausea, and IV morphine. The patient underwent lab tests and procedures which included blood potassium: low, blood sodium: low, and heart rate: 125 bpm - tachycardia all on 01Apr2021. The outcome of the events was recovered.
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| 61 | 2021-04-24 | nausea |
felt like she was going to faint; Chest pain; rapid heartbeat; high blood pressure; dizziness; Heada...
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felt like she was going to faint; Chest pain; rapid heartbeat; high blood pressure; dizziness; Headache; nausea; could not sleep for 6 days; Heart Racing; Body shaking; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: en6208), via an unspecified route of administration, administered in arm right on 12Mar2021 09:30 (at the age of 61-years-old) as a single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included asthma, blood pressure and cholesterol; all from an unknown date. The patient had known allergies. No covid prior vaccination. No other vaccines in four weeks. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR); chlorphenamine maleate, phenylpropanolamine hydrochloride (NASAMEX); simvastatine; ibuprofen; losartan; and furosemide (FUROSE); all were taken for an unspecified indication, start and stop date were not reported. On 13Mar2021 10:00, the patient experienced chest pain, rapid heartbeat, high blood pressure, dizziness, felt like she was going to faint and couldn't walk so dizzy. Her heart raced/heart racing for 5 days, headache, nausea and could not sleep for 6 days and body shaking. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment for the events. Double the dose of losartan for blood pressure. Not tested covid post vaccination. The outcome of the events was recovered.
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| 61 | 2021-04-27 | blood in stool |
thrombocytopenia; Heavy blood in the stool; This is a spontaneous report from a contactable consumer...
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thrombocytopenia; Heavy blood in the stool; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received second dose of BNT162B2 (Lot Number: EN6148), via an unspecified route of administration in arm left on 21Mar2021 as single dose for COVID-19 immunisation. Medical history was none. No known allergies. The pateint was not pregnant. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 28Feb2021 for COVID-19 immunisation. No other vaccine in four weeks. No ther medications in two weeks. The patient experienced Heavy blood in the stool, thrombocytopenia on 07Apr2021. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. No treatment received. No covid prior vaccination. No covid tested post vaccination. No covid tested post vaccination. The outcome of events was not recovered.
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| 61 | 2021-04-27 | nausea |
Tiredness; Chills; Fever; Doesn't feel good, weak; Lymph node swollen, hurts, can't touch it; Nauseo...
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Tiredness; Chills; Fever; Doesn't feel good, weak; Lymph node swollen, hurts, can't touch it; Nauseous; Headache; This is a spontaneous report from a contactable consumer (Patient). A 61-year-old female patient received the second dose of BNT162B2 (COMIRNATY Formulation: Solution for injection) via unspecified route of administration as a SINGLE DOSE on 07Apr2021 02:35PM for COVID-19 immunization. The patient had no relevant medical history and family history. Patient received historical vaccine of first dose BNT162B2 (COMIRNATY) via unspecified route of administration in left arm on 17Mar2021 02:35 PM for COVID-19 immunization. Medical history and concomitant medication was not reported. No family history. Patient reported as does not think her medications had anything to do with the events. she takes all the same medications and didn't have any events with the first vaccine. On 07Apr2021 at 14:35 after second vaccine she got headache right after that and still ongoing. On 08Apr2021 lymph node under arm swollen hurts and she can't touch it and still ongoing, she was nauseous around 5 or 6 in evening. On 08Apr2021 2:00 AM she had chills, tiredness, doesn't feel good weak and fever was 100.5 then it went higher and lower. Second shot on Wednesday and she really sick was 25 percent better today. No Prior Vaccinations (within 4 weeks). The outcome of event recovered for Chills, Fever on 09Apr2021, Nauseous on 08Apr0221 and not recovered for Tiredness, Headache, Doesn't feel good, weak, Lymph node swollen, hurts, can't touch it. No follow-up attempts are needed. No further information is expected.
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| 61 | 2021-04-30 | nausea |
heart was racing; tingling feeling; passed out; dizzy; queasy; I am diabetic; sick; This is a sponta...
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heart was racing; tingling feeling; passed out; dizzy; queasy; I am diabetic; sick; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 10Mar2021 (Lot Number: EN6201; Expiration Date: 30Jun2021) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included 1st dose of BNT162B2 (lot number: EN9581, Expiry Date: 31May2021) on 17Feb2021 and 13 days later patient started feeling sick and wholly got sick. Patient went for the second vaccine and passed out as she got the vaccine right there in the hospital (10Mar2021), so they gave her the vaccine and then patient sick for the next three weeks 3 and half weeks. The first-time patient passed out they took her to the emergency room for whole afternoon on 10Mar2021 because patient was so dizzy and queasy and she guessed they did like 'A1C' on her. They made sure that took blood for her they made sure patient was diabetic. They wanted to make sure there was nothing wrong with patient and then they sent patient home at same afternoon and patient went home and another whole week she was so dizzy and nauseous and now she was tingling feeling. All kind of weird things happened to patient and her heart was racing. Patient took herself back to the hospital after a week. Patient had to stay in the hospital for two days. And then they did MRI on her and a CAT scan and then they sent patient to neurologist and then patient to do another MRI. Patient been for past six weeks was being turmoil. Outcome of the events was unknown.
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| 61 | 2021-04-30 | vomiting, nausea |
severe vertigo; fall down on the floor; nausea; horrible spinning; vomited; dizzy; generalized weakn...
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severe vertigo; fall down on the floor; nausea; horrible spinning; vomited; dizzy; generalized weakness; brain fog; a little tired; a little off; Fatigue; sore arm; couldn't eat; couldn't open her eyes; nystagmus; couldn't walk at all without help; This is a spontaneous report from a contactable consumer, reporting for herself. A 61-year-old female patient received the second dose of the bnt162b2 (BNT162B2; Lot Number: EN6208; Expiration Date: Jun2021), via an unspecified route of administration in the right arm on 19Mar2021 at 13:30 at a single dose for covid-19 immunisation. Medical history included ongoing celiac disease diagnosed in 2012 and has been gluten free ever since, allergies, and anxiety. Concomitant medications included zolpidem tartrate (AMBIEN) taken for sleep; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for allergies; alprazolam (MANUFACTURER UNKNOWN) taken for anxiety; vitamin d nos (MANUFACTURER UNKNOWN) taken for immune system health; and magnesium (MANUFACTURER UNKNOWN) taken for health. The patient previously received the first dose of the bnt162b2 (Lot number: EN6203) at 61 years of age on 26Feb2021 between 5:15PM and 5:30PM in the left arm at a single dose for covid-19 immunization and the flu vaccine (INFLUENZA) for immunization 15 years ago and experienced arm was sore. There were no other prior vaccinations within 4 weeks. On 19Mar2021, the patient experienced sore arm. On 21Mar2021, the patient experienced a little off, fatigue, brain fog, a little tired. On 31Mar2021, the patient experienced severe vertigo, fall down on the floor, nausea, vomited, horrible spinning, generalized weakness. In 2021, the patient experienced couldn't open her eyes, couldn't eat, nystagmus, could not walk at all without help. On an unknown date, the patient experienced dizzy. The events, severe vertigo, fall down on the floor, nausea, vomited, and horrible spinning, required emergency room and physician office (video) visits. The patient was hospitalized for severe vertigo, fall down on the floor, nausea, vomited, and horrible spinning from 31Mar2021 to 02Apr2021. The clinical course was as follows: the patient received the second dose on 19Mar2021 and she didn't really have any bad side effects, a sore arm, and a little tired on the second day, maybe a little off but was fine. 12 days later she was vacuuming and had severe vertigo, she was down on the floor, just horrible spinning, horrible nausea and laid on floor and vomited all day. Her doctor told her to go to the ER. They did all kinds of tests with unknown results on an unknown date and she could not open her eyes for 2 days, she was so violently spinning with vertigo, they gave her fluids. She went in on Wednesday and by Friday she was a little better, she could open her eyes, still had spinning and vertigo. It was like nystagmus, her eyes were, she just really couldn't open her eyes for the doctor, had generalized weakness and couldn't walk at all without help in the hospital. The only time she moved from one position was to go to the bathroom with assistance. In the ER, she could not get up out of bed the first night they were trying all ways of catharizing her. She could not even get out of the bed with the help, they had to carry her to the CAT scan with negative result on 31Mar2021. She had slightly improved but still had vertigo and she was not vomiting anymore, that was only the first couple days. She was sent home with medications for dizziness and nausea but they didn't do anything. Two weeks later she was still dizzy, had vertigo, it was way better than it was, she can open the windows a little bit but she was basically in a dark room for like the first week and a half. Not violent like it was the first couple of days. The events were further described as: she was a little sore on 19Mar2021, 20Mar2021, 21Mar2021, and maybe the 22Mar2021 her arm was still sore. She clarified the sore arm pretty much ended on the 22Mar2021. She was surprised she felt fine on 19Mar2021 and 20Mar2021 and on the evening of 21Mar2021, in the middle of the night between 20Mar2021 and 21Mar2021 she felt a little off and a little more tired. On 21Mar2021, she didn't feel great, fatigued and brain fog but was fine after that. She began feeling a little off and a little tired early morning on the 21Mar2021. That was pretty much gone by the 22Mar2021. The feeling tired and a little off and the brain fog and fatigue went away 22Mar2021. She vomited constantly, started suddenly and violently and was incapable of moving, all she did was vomit and lay on the floor. It was a complete 360, she was fine vacuuming a minute before and then suddenly got dizzy and went down and could never get up. She had to be taken from upstairs in her house and transported to the hospital. She was not really experiencing the nausea now, she was not completely herself but she can eat, she couldn't eat for the first couple of days and was on IV fluids and once she got out of the hospital was able to eat a little and now eating almost normally. It took a week to eat normally and she couldn't eat holiday dinner on 04Apr2021. From 31Mar2021 to 10Apr2021, every day the nausea has slightly been improving. She was not quite herself and still has vertigo and was making herself eat her meals. She vomited 30 times and in the hospital they gave her an IV to stop that and never vomited in hospital, maybe once in the ER. She confirmed the 31Mar2021 was the last time she vomited. She had not recovered completely from nausea. She used be running around all the time, she would walk 10 miles per week to exercise, yesterday she had a mammogram scheduled and she was just so wiped out for doing something for the first time and had to lie down for the whole rest of the day. She was hospitalized from 31Mar2021 until the evening of 02Apr2021 when they let her out. She was given medication for nausea and dizziness didn't do anything. She was given ondasetron (ZOFRAN), 4 mg and meclizine. Because of her weakness, the patient was checked to see if there was any brain bleed or brain stem problems that would explain the vertigo and did not find anything. The tests were negative for any brain problems on an unknown date. Lab data included: blood levels: low on vitamin d (probably because she was not absorbing nutrients as well) on an unknown date, endoscopy: unknown results on an unknown date, and MRI: negative on 01Apr2021. Therapeutic measures were taken as a result of severe vertigo, fall down on the floor, nausea, horrible spinning, vomited, and dizzy. The clinical outcome of the events, severe vertigo, nausea, generalized weakness, could not open her eyes, nystagmus, could not walk at all without help, was recovering. The clinical outcome of the events, fall down on the floor, horrible spinning, dizzy, was unknown. The clinical outcome of the events, a little off, fatigue, sore arm, brain fog, and a little tired, was recovered on 22Mar2021. The clinical outcome of the event, vomited, was recovered on 31Mar2021. The clinical outcome of the event, could not eat, was recovered in 2021. No follow-up attempts are needed. No further information is expected.
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| 61 | 2021-05-05 | diarrhea, vomiting |
Cough; Shortness of Breath; Fatigue, Chills, Muscle or Body Aches, Headaches, New loss of taste or s...
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Cough; Shortness of Breath; Fatigue, Chills, Muscle or Body Aches, Headaches, New loss of taste or smell, Congestion or Runny Nose, Diarrhea; Vomiting. Prednisone (DELTASONE) 10 mg tablet; Take 2 tablets (20 mg total) by mouth 2 (two) times a day for 4 days-Azithromycin (ZITHROMAX) 250 mg tablet; z pack. 500 mg day one 250 mg day 2-5. -Albuterol HFA (PROVENTIL;VENTOLIN) 90 mcg/actuation inhaler; Inhale 2 puffs every 6 (six) hours as needed for wheezing for up to 7 days.
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| 61 | 2021-05-07 | abdominal pain upper |
Very late diagnosing as shingles; Headache at work after vaccine; then got more severe along with le...
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Very late diagnosing as shingles; Headache at work after vaccine; then got more severe along with leg very sensitive and burning feeling; then got more severe along with leg very sensitive and burning feeling; severe stomach pain; This is a spontaneous report from a contactable other HCP (patient). A 61-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration, administered in Arm Left on 28Jan2021 09:00 (at 61 years old), single dose for covid-19 immunisation. Medical history included concussion, endometriosis, all from an unknown date. Concomitant medications included estradiol; progesterone. No other vaccine in four weeks. On 28Jan2021 09:00, patient experienced Headache at work after vaccine , then got more severe along with leg very sensitive and burning feeling, better then 5 nights very severe stomach pain-Dr appt and ER to get sonogram, CT-Very late diagnosing as shingles. The outcome of the events was not recovered. Treatment of adverse events was CT, Sonogram. No covid prior vaccination. Not covid tested post vaccination. No Known allergies. Information about lot/ batch number has been requested; Sender's Comments: Based on known disease pathophysiology, the event herpes zoster is assessed as not related to suspect vaccine BNT162B2.
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| 61 | 2021-05-07 | nausea |
Feeling like maybe there is something wrong with her spleen; The pain is in the left side of the bac...
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Feeling like maybe there is something wrong with her spleen; The pain is in the left side of the back kind of by the lungs; She has been sick; Her mental status was also affected; What scared her was not feeling like she was getting enough oxygen; Nausea; Body pain/flu-like body pain in her muscles over her shoulders; Out of it; Pain in her back where her lungs are; Problems breathing/Her breathing still almost feels labored; Hot and cold sweats; Dizzy; Shaky; Weak; Tired; Headache; Anxious; Fever; Itchy; Arm hurt; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer. A 61-year-old female patient received first dose BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 09Apr2021 13:00 (Batch/Lot Number: TW0151) as SINGLE DOSE for covid-19 immunization. Medical history included cancer, pneumonia, pain in her lungs, smoker and arthritis. The patient's concomitant medications were not reported. The patient experienced what scared her was not feeling like she was getting enough oxygen on an unspecified date, problems breathing/her breathing still almost feels labored on 11Apr2021, arm hurt on 09Apr2021, pain in her back where her lungs are on 11Apr2021, hot and cold sweats on 10Apr2021, dizzy on 10Apr2021, shaky on 10Apr2021, nausea on 13Apr2021, body pain/flu-like body pain in her muscles over her shoulders on 11Apr2021, out of it on 11Apr2021, weak on 10Apr2021, tired on 10Apr2021, headache on 10Apr2021, anxious on 10Apr2021, fever on 10Apr2021, itchy on 09Apr2021, feeling like maybe there is something wrong with her spleen on an unspecified date, the pain is in the left side of the back kind of by the lungs on an unspecified date, she has been sick on an unspecified date, her mental status was also affected on an unspecified date. Patient had the first dose of the Covid Vaccine on 09Apr2021 and gradually her arm hurt, she had hot sweats, she felt dizzy, was shaky, had nausea, and had body pain. The one thing she is concerned about was she had pain in her back where her lungs are and she was having problems breathing. She has a little bit of that still. She has also been out of it. Her breathing still almost feels labored, and this past weekend she thought she would go to the emergency room. Her main concern is this awful pain in her back while she was having problems breathing and getting enough oxygen. She felt weak, dizzy, and shaky. She got scared. She has been sick, she had cancer a long time ago. What scared her was not feeling like she was getting enough oxygen. The pain is in the left side of the back kind of by the lungs. It goes directly from the front to the back. On Monday it started feeling better. Today it is so much better. She will feel like she is not getting enough oxygen or giving a full breath and then this in her back. She remembers having pneumonia years ago and having pain in her lungs. That's why she knows the pain is in the back of her lungs. She has to say she is a smoker. She slowed down and couldn't smoke this week or during that. She kind of quit, that's her reality now. The pain comes and goes throughout the day but it is not as bad. She didn't have this shortness of breath and other things until a couple days after she got the vaccine. It gradually came up on her. She was not having trouble breathing, it was more slightly labored. It was not profound, just there. Sometimes when she is speaking after a while she gets tired and will have to take a moment and take a deep breath. It is so much better. She called her primary care physician and was anxious, and all he said was she would feel effects for 2 weeks. He wasn't very helpful. Her arm hurt the day that she had the shot. Even today there are little bits of pain but very light. 09Apr2021 through 11Apr2021 was when everything really hit. It was hard to lift up her arm. It was a little pain, it was no big deal. She would have the AC on and blast it when she had the hot and cold sweats. She was using napkins because she was sweating profusely. It felt like she obviously had a reaction to the vaccine. It's normal she guesses. She didn't expect it for the first dose. The 11th, 12th, 13th, and 14th it was really bad. Her whole body was sweating and would get wet. She'd be hot and then cold. She was anxious because she was having problems breathing. She still gets a little bit of hot and cold sweats, but nothing compared to what she went through. As the days go on she is slowly getting better. She was dizzy not just during the day, at night she couldn't sleep because of it. She has gradually gotten better. Yesterday she tried to do some gardening but felt so weak she had to come back inside. When she gets up she feels weak and a little bit of lack of air. She has labored breathing. She was real itchy. The shakiness, dizziness, and anxiety all came on and were horrible. She doesn't know if the nausea was because she couldn't eat and had to take her regular medication. It was very light nausea. She had flu-like body pain in her muscles over her shoulders. Her headache was major too during all of this. The headache is something that comes and goes still. It is a weird kind of headache. She had a fever and got like flu all over body pain. She doesn't know how to explain how she felt out of it. She doesn't know if it was the fact she was so sick. She had a feeling of did she do that. She couldn't make decisions. She would need to take the garbage out and go back to the garbage and think what did she come here for. Her mental status was also affected. The weakness gradually got really bad, and she still hasn't recovered from it. She still feels weak and tired when trying to do things. She was tired the day after she got the vaccine. The first day she thought it was nothing and she was fine. Gradually it got real bad when she was sick. She didn't feel that flu-ish feeling but was weak and tired. She got dizzy and she had the brain fog thing. She was having really bad headaches during the same time. The weakness and tiredness go hand in hand. She takes a mineral for her thoracic spine, but she takes that more for elderly arthritis. She doesn't have any conditions that she thinks played a role. She has been feeling like maybe there is something wrong with her spleen. Took Tylenol for her fever. Mentioned fever would go away and come back. The patient underwent lab tests and procedures which included body temperature: 102, 99 and 100.1 (unit unspecified) all on unspecified dates. Therapeutic measures were taken as a result of fever and itchy. Outcome of the event problems breathing/her breathing still almost feels labored, arm hurt, pain in her back where her lungs are, hot and cold sweats, dizzy, out of it and headache was recovering. Outcome of the event fever was recovered on 13Apr2021, itchy was recovered with sequelae on 14Apr2021, body pain/flu-like body pain in her muscles over her shoulders was recovered on 16Apr2021, nausea was recovered on 16Apr2021, shaky was recovered on 19Apr2021. Outcome of the event weak and tired was not recovered. Outcome of all the other events was unknown.
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| 62 | 2021-01-02 | diarrhea, decreased appetite |
Approximately 12 hours after injection, sudden onset headache, went to bed and woke a couple hours l...
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Approximately 12 hours after injection, sudden onset headache, went to bed and woke a couple hours later with severe back pain, neck pain, deep muscle ache in legs, low grade fever. 24 hours after injection, some decrease in pain with Tylenol, diarrhea, fatigue, general malaise. Loss of taste, loss of appetite . 48 hours post injection- subsiding muscle aches, other symptoms on going, 72 hours post to present, diarrhea, loss of appetite
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| 62 | 2021-01-03 | abdominal discomfort, diarrhea |
Arm was sore for about three days. On 12/21 evening, had headache, some lightheadedness and severe ...
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Arm was sore for about three days. On 12/21 evening, had headache, some lightheadedness and severe back muscle ache. On 12/22, had stomach upset, extreme fatigue, nasal congestion. On 12/24, had diarrhea. Fatigue continued until at least 12/29.
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| 62 | 2021-01-04 | decreased appetite, nausea |
By 1400 had low grade HA, by 1600 more severe. Managed with Tylenol. 1800 no appetite, and nauseat...
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By 1400 had low grade HA, by 1600 more severe. Managed with Tylenol. 1800 no appetite, and nauseated. Continued through night.
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| 62 | 2021-01-04 | nausea | light headed and nausea for 3 days |
| 62 | 2021-01-04 | nausea |
fast heart beat; it was like she didn't feel good; low grade fever; nausea; headaches; chills; sore ...
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fast heart beat; it was like she didn't feel good; low grade fever; nausea; headaches; chills; sore arm /arm soreness; tired; felt like she had a flu; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. Medical history included Diabetes, allergies, heart (Heart disorder). Concomitant medications included irbesartan (AVAPRO) for heart, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for allergies, metoprolol for heart, metformin for Diabetes, all were ongoing. The patient (Hospital scheduler/employee) had been experiencing side effects of the vaccine. She took the vaccine on 18Dec2020 and still experiencing nausea, headaches, and chills. She asked how long she would experience these side effects and if she needed to take anything. Patient reported she was exposed to someone who had COVID, her son's girlfriend had direct exposure to COVID and wanted to know how it would affect her. The patient further stated she was a hospital scheduler, she had the Pfizer Covid vaccine on 18Dec2020. She had a sore arm/arm soreness and was tired immediately after (18Dec2020), stated by Saturday 19Dec2020, she started having a low-grade fever, chills, headache, nausea, and still had the soreness in the arm. This went on for 2-3 days. Patient stated that up until now, she still had nauseous feeling that happened intermittently around early morning or mid-day, the chills were midday to early evening, it was like she didn't feel good, had to leave early from work. The fever only lasted a couple of days. She also had one isolated episode of fast heart rate that woke her up in the early hours of Sunday 20Dec2020. Caller stated she expected some of these effects to only last a couple of days but wanted to know if this was normal. She tried working 2 days last week and by mid-day she was just really tired, like she was about to get the flu, she felt like she had a flu just with no respiratory symptoms (De2020). She knew of one other coworker who was experiencing similar symptoms. No patient identifiers were provided, no further information provided. Patient did have history of allergies from when she was a child and was on medication, she was on over the counter medication Zyrtec for years, she didn't know if there could be a conflict between them. She received her vaccine part of the hospital. She also called because her son and his girlfriend live in her house and his girlfriend was exposed to someone who tested positive for Covid, she wanted to know how this may affect her since she had the vaccine. Investigation assessment was no. The outcome of the event "sore arm /arm soreness" was recovered in Dec2020, of "low grade fever" was recovered on 21Dec2020, of the events "tired", "nausea", "headache" and "chills" was not recovered, of the other events was unknown. Information about Lot/Batch number has been requested.
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| 62 | 2021-01-04 | vomiting, loss of appetite |
Persistent vomiting from 3am to about noon on Monday. Fever of 38.4 ' C. Headache, chills, fatigue....
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Persistent vomiting from 3am to about noon on Monday. Fever of 38.4 ' C. Headache, chills, fatigue. Slept most of the day. Took acetaminophen when able to drink. Drank ginger tea and ate dry toast in the evening. Tuesday, HA controlled with Acetaminophen and Ibuprofen. Able to eat and increase fluids. Consulted with my PCP who suggested I enter my information. Feeling stronger as time passes. I believe another nights sleep will help.
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| 62 | 2021-01-05 | diarrhea, abdominal pain upper |
stomach cramping; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 6...
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stomach cramping; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1685), via an unspecified route of administration on 28Dec2020 at 11:45 at 62-years-old at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 28Dec2020, the patient experienced: stomach cramping and diarrhea; which was assessed as non-serious. The clinical course was reported as follows: The patient stated she had the vaccine on 28Dec2020 at 11:45 and "maybe an hour later", her stomach start cramping and then had diarrhea. The patient wanted to know if that was something "to be concerned about." In regard to having any laboratory test, the patient stated, "I went in November sometime for my annual checkup I think it was November" (as reported). When the patient was asked if they received any treatment for the events, the patient stated, "No. I am still at work, I got it today, I haven't taken anything but I was thinking that to just get some "Caper" (as reported) and "gentian soda" (as reported)." The clinical outcome of the events was unknown.
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| 62 | 2021-01-05 | nausea, vomiting |
I got my shot on the 19th and that evening it was like a light switch and I was so tired I went to s...
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I got my shot on the 19th and that evening it was like a light switch and I was so tired I went to sleep at 730pm I had severe chills and fever and had to go to bed. The next day I still wasn't feeling well and I was called in to get covid tested and I went to the ER on the 21st and took a rapid covid test that was positive. I was stable and had good oxygenation and was discharged. I have fever nausea vomiting I also had problems with O2 stat i was in the 80s and realized I was having respiratory failure so I was admitted on the 27th and I've been here ever since. I had kinetic storm and infusions my O2 stats were bad and I was sent to the covid unit and put on high flow oxygen and negative for a PE, I'm still on the covid unit but I feel much better today
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| 62 | 2021-01-05 | nausea |
1/2/21- 1/5/21 Fever, chils, arthralgias, swollen throat, nausea, BLURRY VISION, RED eyes, white no...
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1/2/21- 1/5/21 Fever, chils, arthralgias, swollen throat, nausea, BLURRY VISION, RED eyes, white noise in ears, fatigue lacinating pain ankles, knees ,wrist and finger joints; pain along nerves and vessels fingers with right fourth DIP ulnar side small vessel bleed hematoma 4 cm x 4cm swelling; NO trauma sedenatry Saw Urgent care 1/4/21 -with negative covid 19, strep and flu tests said was repsonse to vaccine Saw primary 1/5/21 Dr hopsital, said probably had covid before and was repsonse to vaccine. 1/6/21; all fingers still swollen no pain most other symptoms improving but TIRED
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| 62 | 2021-01-05 | nausea |
Feeling unwell; Headache; Tiredness; Muscle pain; Chills; Nausea; Injection site pain; had been asle...
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Feeling unwell; Headache; Tiredness; Muscle pain; Chills; Nausea; Injection site pain; had been asleep most of the whole day; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiration date: Arp2021), via an unspecified route of administration on 30Dec2020 at single dose at right arm for Covid virus. Medical history included blood thinner treatment. Concomitant medication included ongoing apixaban (ELIQUIS) for blood thinner treatment. The patient previously took coumadin, warfarin. Patient received the Covid-19 vaccine yesterday. She had been asleep most of the whole day (Dec2020). She had injection site pain, headache, tiredness, muscle pain and chills. She thought she was going to work but that didn't work. She was currently taking Eliquis. She had been on coumadin and warfarin before. She looked at the different medications that needed to be reported. She would also call her physician and make her aware. The start date for "Injection site pain" was 30Dec2020. The start dates for headache, tiredness, muscle pain and chills all were 31Dec2020. The patient also experienced nausea, feeling unwell on 31Dec2020. Investigation assessment was no. The outcome of the event "Injection site pain" was not recovered. The outcome of the other events was unknown.
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| 62 | 2021-01-06 | diarrhea, abdominal pain, nausea, vomiting |
I had the 1st Pfiser Covid Vaccine on 12/21/20 and on 12/24/20 I had abdominal pains resulting in di...
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I had the 1st Pfiser Covid Vaccine on 12/21/20 and on 12/24/20 I had abdominal pains resulting in diarrhea turning into bright red bleeding by the late morning on 12/25/20. I continued to bleed for hours (only when cramping) and ended up going to an ED for severe abdominal pain, bleeding, nausea and general weakness. The ED doctor said it was from internal hemorrhoids and the diarrhea and was not sure it was related to the Covid Vaccine and possible being an intestinal flu but I felt like I needed to report. I also had nausea and vomiting the evening of 12/26/20 lasting about 12 hours. It took me a few days of Zofran and Imodium to get it in control and the bleeding did stop by 12/27/20.
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| 62 | 2021-01-07 | diarrhea |
Diarrhea; This is a spontaneous report from a non-contactable healthcare professional (patient). A ...
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Diarrhea; This is a spontaneous report from a non-contactable healthcare professional (patient). A 62-year-old female patient the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: not provided), via an unspecified route of administration on the left arm on 30Dec2020 08:15 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included asthma, psoriasis, arthritis, overactive bladder, and obesity. The patient also had allergies with penicillin and many non-steroidal anti-inflammatory drugs (NSAIDS). Concomitant medications included etodolac (LODINE), zinc (ZINC), mirabegron (MYRBETRIQ), colecalciferol (VIT D3), ascorbic acid (VIT C), and famotidine (PEPCID). It was reported that the patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 30Dec2020 18:00, the patient experienced diarrhea. The patient received bismuth subsalicylate (PEPTO-BISMOL) and loperamide as treatment. The patient was recovering from the event. No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
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| 62 | 2021-01-07 | nausea |
Tested Positive for COVID-19/nausea, occasional dry cough, neck and lower back soreness, and sore th...
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Tested Positive for COVID-19/nausea, occasional dry cough, neck and lower back soreness, and sore throat; Tested Positive for COVID-19/nausea, occasional dry cough, neck and lower back soreness, and sore throat; Weakness/generalized weakness; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received first dose of BNT162b2 (Pfizer, Lot number: 5730), via an unspecified route of administration at right arm at 22Dec2020 21:00 at single dose for covid-19 immunization. Medical history included Mayonaise allergies. The patient's concomitant medications were not reported. The patient previously took codeine and experienced allergies. At 31Dec2020 06:00, the patient experienced Weakness, nausea, occasional dry cough, generalized weakness, neck and lower back soreness, and sore throat which has now dissipated. Tested Positive for COVID-19 on 02Jan2021 (also reported as 01Jan2021, pending clarification). The covid test type post vaccination was Nasal Swab, Covid test name post vaccination was COVID-19 PCR ROCHE c6800(NTX), RNA SARS CoV2 TGT1, PAN SARS RNA TGT2. No treatment received for events. The events result in Emergency room/department or urgent care. The patient was not pregnant. The outcome of the events were nor recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.
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| 62 | 2021-01-07 | nausea | Chills, headache, muscle pain, tiredness, and nausea. |
| 62 | 2021-01-07 | nausea |
Tachycardia (HR in the 110s), felt warm, forearms visibly flushed, nausea 20 min post vax Observatio...
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Tachycardia (HR in the 110s), felt warm, forearms visibly flushed, nausea 20 min post vax Observation and fluids Sxs resolved after 15 mins of close monitoring NKA
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| 62 | 2021-01-07 | nausea |
10:23pm felt a slight headache and nausea. Left work at 10:43pm since didn't feel good. While on r...
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10:23pm felt a slight headache and nausea. Left work at 10:43pm since didn't feel good. While on road, my tongue started to tingle and then my lips started to tingle and both sides of face felt numb. This started around 10:50pm? Went to bed and woke up Sat with same tongue, lip tingleling and face numbness. Lips felt very swollen. Felt that way throughout the weekend. On Monday, went back to work place injection area and requested someone talk to me. Nurse practioner came out and spoke to me, asked about balance of facial features, no problem breathing or swallowing and gave me 25mg benadryl to take 3 times a day. Did nothing but make me sleepy. She calls me Tue am and told me to make an appt with PCP. Made phone appt for Wed. Dr calls me Wed am and gives me presciption for 60mg Prednisone to take for a week (at this time symptoms are the same). the first 3 days taking Prednisone the intensity of tingleling seems to lessen day by day. But on 4th day, the symptoms stopped lessening. Finished the meds anyway. Last 3 days, i've also had that mild headache back in addition to the numbness from face traveling up to my ears. Past few days the tingling in tongue isn't confined to just the edges of the tongue. It started with the first 1/4 of whole tongue and is today tingleling in the front half of whole tongue. One good thing so far is the past few days, my lips feel way less swollen and tingleling is lessening. So, riding this out, hoping it will end sometime this year. Will not be getting the second shot. Just so you know.
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| 62 | 2021-01-07 | nausea |
Fine pin point rash and itching noted 45 minutes after shot given. Rash noted to neck,spine,hips,upp...
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Fine pin point rash and itching noted 45 minutes after shot given. Rash noted to neck,spine,hips,upper back,upper chest and bend of both arms.Benadryl 25 mg OTC 1/6/21 and 1/7/21.Itching. Itching decreasing 1/8/21. Having copious side effects also of injection site pain,tiredness,headache,joint and muscle pain,nausea,lymphadenopathy and feeling unwell.1/6/21,1/7/21 but feeing better when tylenol 500mg ing system to relieve aches and pains
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| 62 | 2021-01-07 | nausea |
Back pain; Muscles felt really tightened up and stiff when getting out of bed and throughout the day...
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Back pain; Muscles felt really tightened up and stiff when getting out of bed and throughout the day (worst complaint); slight nausea/nausea; slight fatigue; slight headache; slightly stiff neck; right arm pain; The muscles knot up under her rib cage/muscle tightness; This is a spontaneous report from a contactable other health care professional. A 62-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL1284), intramuscularly in the left arm on 29Dec2020 at 06:30 at a single dose for COVID-19 immunization. Medical history included Hashimoto's thyroiditis from an unknown date and unknown if ongoing. Concomitant medications included ergocalciferol (VIT D), levothyroxine (MANUFACTURER UNKNOWN); both taken for an unspecified indication from an unspecified date to an unspecified date. The patient previously took sulfamethoxazole and trimethoprim (BACTRIM) and experienced allergy from an unspecified date to an unspecified date, influenza vaccine (FLU VACCINE) for an immunization on an unspecified date (received within two weeks of vaccination). The patient experienced the following events and outcomes: muscles felt really tightened up and stiff when getting out of bed and throughout the day (worst complaint) (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, slight nausea/nausea (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, slight fatigue (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, slight headache (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, slightly stiff neck (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, right arm pain (non-serious) on 30Dec2020 with outcome of unknown, back pain (non-serious) on 31Dec2020 with outcome of unknown, the muscles knot up under her rib cage/muscle tightness (non-serious) in Dec2020 with outcome of unknown. The patient received the COVID-19 vaccine on 29Dec2020 at work, and she had been experiencing adverse events since. The worst side effect she was experiencing was muscle tightness. At the time of the report, the patient got up at 09:00, and her "back was killing her." The patient was achy. The patient would tighten up really tight under both rib cages, and it made her nauseous. The patient had been taking ibuprofen (ADVIL) and ibuprofen (MANUFACTURER UNKNOWN since she received the vaccination. The patient received the vaccine in her left arm, but her right arm hurt the next day. The next day after that (30Dec2020) she woke up and the right side of her back around the kidney area hurt. It was the right side lumbar. The next morning after that, "her entire back was killing her down the middle of her spine. From her head all the way down." Since then, it came and went. The patient could not say if it was persisting, improving or worsening for any of the symptoms. "It just grabs her." The day before the report, the patient thought she was doing better. The patient cleaned the house, and then sat down to eat. The past two nights, it had "hit her really hard during supper time." Both of her sides of her back would tighten up; "tense up like waiting for an impact before a wreck." The patient's back would seize up. The patient could not get comfortable; and would start pacing. Then, she would try to lay down. Last night, it took a half an hour to loosen back up. "It knots up like crazy. It was bad enough, she thought she was going to pass out." The patient did not know if it was the combination of eating supper or what. The patient thought if she got up that maybe she would feel better. The patient started pacing around. The patient went outside because she thought maybe fresh air would help. When it would tighten up under her rib cage, it made her nauseous. The patient did not know if it was a "vagus nerve thing or what." The patient was close to throwing up. The muscles knot up under her rib cage. The patient's back felt like she fell off a horse. It was weird to her that her left arm never bothered her. "Nothing stays the same." Sometimes it was her entire arm or part of the arm that hurt. Like on top of her forearm. The patient thought she was doing good and then it would come back. When she moved her arm upward, she felt it. The patient said she could deal with the arm pain. It was the knotting up pains that were the worst. The patient tried calling an institute (name withheld) because it happened while eating dinner the other night. The institute (name withheld) "nurse was useless." The pain was across her sacroiliac area. The patient had been "living on Advil and ibuprofen for her back pain." The patient had been taking them together. The patient worked nights, and she was planning on going to work the night before the report, but she had to text her boss and tell her she could not come in. The patient was in good health; had perfect blood pressure and her sugar was normal. The patient was not diabetic. The patient's labs were always normal. The patient was really dreading that second shot. "The flu shot kicked her butt for a couple of days, but this was way worse." The patient started reading up on the COVID vaccine, and it said usually younger people had severe side effects. That old people have less of a response. The patient did not know why she was experiencing such side effects. At the time of the report, it was day 7 or 8, and she was still feeling bad. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
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| 62 | 2021-01-07 | vomiting, nausea, retching | body aches, low grad temp, nausea that led to one episode of dry heave vomiting, weakness & fatigue |
| 62 | 2021-01-07 | vomiting |
At 12 hrs after injection vomiting and severe chills for an hour. 15 hrs after injection severe bod...
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At 12 hrs after injection vomiting and severe chills for an hour. 15 hrs after injection severe body aches for an hour. 18 hrs after injection was mild-moderate headache and moderate tiredness and confusion for another 4-6 hrs.
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| 62 | 2021-01-08 | nausea, vomiting | Myalgia, NauseaVomiting, chills |
| 62 | 2021-01-09 | nausea, vomiting | Fever, chills, nausea, vomiting, dizziness, generalized ache for 24 hours. Tylenol, Zoran, Pepcid |
| 62 | 2021-01-10 | nausea |
On 1/6/21, I received the initial COVID vaccination. Later that evening, I started to experience pai...
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On 1/6/21, I received the initial COVID vaccination. Later that evening, I started to experience pain, swelling and redness at the injection site (right arm). I also had a severe headache with nausea. I was directed to get a COVID test, at the hospital on 1/7/21. I continued to experience these side effects of the vaccine for the next 2 days.
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| 62 | 2021-01-10 | nausea |
ON 12/31/20 AT 1PM, DEVELOPED SORENESS AT INJECTION SIGHT, GREATER THAN NOTICED WITH OTHER VACCINATI...
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ON 12/31/20 AT 1PM, DEVELOPED SORENESS AT INJECTION SIGHT, GREATER THAN NOTICED WITH OTHER VACCINATIONS. LASTED 48-72 HOURS. ALSO HAD HEADACHE, WHICH WAS PRESUMED TO BE SINUS HEADACHE, BUT DID NOT RESPOND TO SINUS MEDICATION. HEADACHE CONTINUED THRU 1/1/21 WITH NAUSEA ALSO NOTED. SYMPTOMS SUBSIDED BY 1/2/21
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| 62 | 2021-01-10 | nausea |
Patient's reaction(s) noted during COVID vaccine observation period: Pain on left side of neck (same...
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Patient's reaction(s) noted during COVID vaccine observation period: Pain on left side of neck (same side as injection site) ) and waves of nausea. Actions Taken: VS taken and WNL. Pt states the nausea is resolving and she feels comfortable just going home.
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| 62 | 2021-01-10 | nausea |
Starting on 01/09/2021 at 02:00am woke up nauseous and hot. Body aches especially r arm with tinglin...
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Starting on 01/09/2021 at 02:00am woke up nauseous and hot. Body aches especially r arm with tingling in r hand, dizziness and chills throughout the day They would come and go. Late afternoon, Biceps went into spasms all fingers aching. After nap at 06:00 woke up and all symptoms gone. On 01/10/2021, woke up with tingling and burning from bilateral knees to toes. Lasted 2 hours and then gone. In afternoon 1 episode of dizziness and hot flashes followed by chills. 01/11/2021 Slight headaches. No bodyaches or other symptoms.
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| 62 | 2021-01-11 | diarrhea, nausea |
Nausea; Diarrhea; Jitteriness; foggy head or brain; she can't concentrate /she didn't pay it any att...
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Nausea; Diarrhea; Jitteriness; foggy head or brain; she can't concentrate /she didn't pay it any attention; sleeping a lot; sick; Headache; body aches; This is a spontaneous report from a contactable nurse. A 62-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), via an unspecified route of administration on 05Jan2021 08:15 at single dose for COVID-19 immunisation. Anatomical location of administration of vaccine was right deltoid. Medical history was not reported. The patient previously took omeprazole (PRILOSEC) and experienced drug hypersensitivity and lip swelling. Concomitant medication included atorvastatin (LIPITOR). The patient experienced headache on Jan2021, body aches on Jan2021, nausea on 06Jan2021, diarrhea on Jan2021, jitteriness on Jan2021, foggy head or brain on Jan2021, sleeping a lot on Jan2021, sick on Jan2021, she can't concentrate /she didn't pay it any attention on Jan2021. The outcome of headache and she can't concentrate /she didn't pay it any attention was recovering, of pain, jitteriness, foggy head or brain was not recovered, of sleeping a lot and sick was unknown. Nausea, and diarrhea recovered on 07Jan2021.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events headache, pain, nausea, diarrhea, feeling jittery, feeling abnormal, disturbance in attention and hypersomnia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 62 | 2021-01-11 | nausea | Chills, Headache, Nausea, Body Aches |
| 62 | 2021-01-13 | decreased appetite, vomiting |
was afraid; she was nervous; vomiting; Fatigue; felt chills/chill became a bone chill, and she was f...
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was afraid; she was nervous; vomiting; Fatigue; felt chills/chill became a bone chill, and she was freezing; felt chills/chill became a bone chill, and she was freezing; randomly felt miserable/she felt like her body was purging/feeling "blah"; she wasn't really eating; Feeling sick; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK5730), via an unspecified route of administration in her right upper arm on 22Dec2020 16:00 at single dose for COVID-19 immunization. Vaccination Facility Type is hospital and which was not a facility. Medical history included type 2 diabetes mellitus from an unknown date and unknown if ongoing and it was maybe 10 years ago that she was diagnosed, and she was treated for her diabetes. There were no concomitant medications. There was no history of all previous immunization with the Pfizer vaccine (within 4 weeks) or additional vaccines administered on Same Date of the Pfizer Suspect. The patient received the first dose of the COVID-19 vaccine 22Dec2020 and is due for her second dose this upcoming Tuesday, 12Jan2021. She asked if it would be safe to receive the second dose at a different time, due to personal plans. She said after she received the first dose of the COVID-19 Vaccine on 22Dec2020, she was feeling sick in Dec2020. She said she had vomiting, chills, and randomly felt miserable, fatigue from 23Dec2020. She said she was nervous about getting the second dose of the COVID-19 Vaccine on Tuesday, 12Jan2021. She said she had plans around that time period and she was afraid she was going to be sick after she receives the second COVID-19 Vaccine dose. She asked if the second COVID-19 Vaccine dose had to be administered in the timeframe that was scheduled. The patient reported she felt chilled when she woke up the next morning, 23Dec2020. She said at first she thought she felt chilled because it was cold outside. She said after she arrived at work on 23Dec2020, the chill became a bone chill, and she was freezing. She said she realized the chill was not a normal cold feeling. She said by mid-morning on 23Dec2020, she began to vomit, and went home and went to bed. She said she got sick 2 more times that day. She said she went to work on Thursday, 24Dec2020, and randomly got sick. She said she wasn't really eating at that point (Dec2020), so it was not like she got sick before or after she ate something. She said she continued to get randomly sick through holiday, 25Dec2020. She said she felt like her body was purging. She said she was feeling "blah", but she was not bedridden or out of commission. She said she had no fever that she knew of. She said her symptoms resolved right after holiday, clarifying she started to feel like herself, saying she felt good. The patient declined any treatment and reported she didn't think her symptoms were that severe, though her family wanted her to go to the doctor. There was nothing had changed in her routine prior to receiving the first dose of the COVID-19 Vaccine. Reported she had blood work every 4 months, and her last blood work was probably done in Oct2020 or Nov2020. The events did not require a visit to emergency room or physician office. The outcome of the event feeling sick, she wasn't really eating, were resolved in Dec2020, outcome of fatigue, felt chills/chill became a bone chill, and she was freezing were resolved on 23Dec2020, outcome of vomiting, randomly felt miserable/she felt like her body was purging/feeling "blah" were resolved on 25Dec2020, outcome of fear and nervous were unknown.
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| 62 | 2021-01-13 | diarrhea, nausea |
Body aches; fever; chills; diarrhea; headache; joint pain; nausea; fatigue; This is a spontaneous re...
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Body aches; fever; chills; diarrhea; headache; joint pain; nausea; fatigue; This is a spontaneous report from a contactable other HCP (patient). This 62--year-old female HCP reported for herself received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: unknown), via intramuscular route of administration, on 07Jan2021at 02:00 PM (at the age of 62 years old) as a single dose in the left arm for COVID-19 immunization at hospital facility. Relevant medical history included chronic Fatigue. The patient have known allergies to Sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included liothyronine sodium (T3), levothyroxine sodium (T4), progesterone, estradiol, estriol (BIESTROGEN), testosterone, colecalciferol (VITAMIN D), calcium, zinc sulfate (XINC), ascorbic acid (Vitamin C), magnesium. The patient previously received the first dose of BNT162B2 (lot number/expiration date: unknown) on 17Dec2020 at 10:30 AM (at the age of 62 years old) as a single dose in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Jan2021 at 10:00 PM, after the second dose, the patient experienced body aches, fever, chills, diarrhea, headache, joint pain, nausea, fatigue. No treatment was received for the events body aches, fever, chills, diarrhea, headache, joint pain, nausea, fatigue. The outcome of the events body aches, fever, chills, diarrhea, headache, joint pain, nausea, fatigue was recovering. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 62 | 2021-01-13 | nausea |
0944 C/O NAUSEA, WARM SENSATION (OVERALL), TACHYCARDIA, LIGHTHEADEDNESS, SL. SHORTNESS OF BREATH. E...
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0944 C/O NAUSEA, WARM SENSATION (OVERALL), TACHYCARDIA, LIGHTHEADEDNESS, SL. SHORTNESS OF BREATH. EMS ON SITE. VS: 168/71, p: 58; 97% O2 SAT R.A.; 0954: BP: 168/71, P: 58, 98% 02 SAT R.A. 1015: LEFT AND WENT TO HOSPITAL. ALERT, ORIENTED
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| 62 | 2021-01-13 | nausea |
Got first dose around 3pm Jan 12. Foot cramp around 10:30pm. Took magnesium. On Jan 13, Brief dizzy ...
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Got first dose around 3pm Jan 12. Foot cramp around 10:30pm. Took magnesium. On Jan 13, Brief dizzy spell 7am (a few seconds); minute long dizzy spell around 3pm, another around 3:15, then a 2-hour long dizzy spell beginning around 3:30pm. Queasy till 9 pm, but no vomiting. Foot cramp again, so I got up and drank more water and took magnesium. Felt steadier.
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| 62 | 2021-01-13 | nausea | nausea, HA, chills , fatigue after second shot |
| 62 | 2021-01-13 | nausea |
Knot in arm, very sore arm, severe headache, fatigue, chills, fever, nauseous all on first night af...
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Knot in arm, very sore arm, severe headache, fatigue, chills, fever, nauseous all on first night after shot. All gone by next morning with the exception of the headache, which is not as severe now.
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| 62 | 2021-01-14 | decreased appetite, vomiting |
As per Emergency Dept note of 23 Dec 2020: "Syncope, related to getting the vaccine. Normal ECG, no...
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As per Emergency Dept note of 23 Dec 2020: "Syncope, related to getting the vaccine. Normal ECG, no evidence of arrhythmia, normal H/H, no evidence of ACS, CHF clinically. Normal nonfocal exam. Symptoms resolved. Home with reassurance." As per follow-up note of 04 Jan 2021: "62yo female s/p first dose of Pfizer-BioNTech vaccine on 12/23/2020 who experienced syncope, hypertension (200/100) within minutes after receiving the vaccine. She was then transported to the ED where she was given IV fluids, anti-emetic and discharged a few hours later. She reports the onset of fever, chills, anorexia, malaise, and emesis 4 hours after receiving the vaccine. The malaise, chills and anorexia persisted for 4 days at which point she started feeling better. COVID test was reportedly negative. She wants to decline 2nd dose of vaccine."
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| 62 | 2021-01-14 | nausea, diarrhea, abdominal pain upper |
Advised received first covid vaccine 12/21/2020 w/o issues. Received 2nd Pfizer vaccine on 1/11/21. ...
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Advised received first covid vaccine 12/21/2020 w/o issues. Received 2nd Pfizer vaccine on 1/11/21. Within minutes her tongue was tingling with sensation of feeling full-felt funny. 30 min later had frontal/jaw headache. 60 min later chills with goose bumps all over while working (works as resp technician at NMCP). While walking to car, her upper arm and front of thighs hurt as if exercised too much. Self treated with Advil and tylenol. --- Next day 1/12 0100am awoke with severe bilateral shoulder joint pain extending to shoulder blades, stabbing abdominal/stomach pain, nausea, urge to vomit. she returned to sleep but awoke 6am with nausea and severe diarrhea and fatigue. She c/o nasal congetion, sinus fullness and severe post nasal drip x 24 hours. S/s persisted and left work early now with severe bilateral ankle pain. She was off Wed/Thursday. Wed 1/13 her shoulder pains eased but now with severe back pain. Wed evening noted tongue swelling sensation again (has pictures) and took oral benadryl and ice chips. She went to sleep. Thursday 1/14 bilateral knee pain/joint with increased nausea again - treated with zofran. Friday 1/15 returned to work, pain in knees made gait wobbly = treated with advil. Notified ID MD and director on tongue swelling and constantly trying to clear throat = sent to ER where treated with oral decadron and M Toradol for pain. She was sent home with prednisone dose pack and compazine. Recommended f/u with HCP for further testing to r/o possibility of a mast cell disorder of familial hypertrytassemia due to her history of multiple allergies/insect allergies--
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| 62 | 2021-01-14 | nausea |
chills; fever; intense body pain all over; headache; nausea; This is a spontaneous report from a con...
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chills; fever; intense body pain all over; headache; nausea; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration on 05Jan2021 17:30 in right arm at single dose for COVID-19 immunization. Medical history included hypopituitarism from an unknown date and unknown if ongoing. The patient received first dose of BNT162B2 (lot number: EJ1685), on 18Dec2020 10:45 in left arm at single dose. Concomitant medication included second dose of varicella zoster vaccine rge (cho) (SHINGRIX) for immunization, hydrocortisone acetate (CORTEF), levothyroxine sodium (SYNTHROID), desmopressin acetate (DDAVP), simvastatin, estrogens conjugated, medroxyprogesterone acetate (PREMPRO) and losartan potassium (LO). On 06Jan2021 08:00, the patient experienced chills, fever, intense body pain all over, headache and nausea. No treatment was given to the patient for the events. The patient recovered from the events in Jan2021. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient received SHINGRIX within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
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| 62 | 2021-01-14 | nausea |
2nd dose next day had nausea in am since subsided. chills muscle aches and swelling soreness at arm ...
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2nd dose next day had nausea in am since subsided. chills muscle aches and swelling soreness at arm site present @ this time.
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| 62 | 2021-01-14 | nausea | Body aches, chills, cough, headache, nausea, soreness and swelling of L arm pit. |
| 62 | 2021-01-14 | nausea | Fatigue, body aches, nausea. Resolved. |
| 62 | 2021-01-14 | nausea | body aches, chills, cough, headache, nausea--soreness/swelling left armpit |
| 62 | 2021-01-16 | decreased appetite, nausea |
chills, fever over 102, terrible headache, body aches, sore arm, loss of appetite, nausea, severe fa...
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chills, fever over 102, terrible headache, body aches, sore arm, loss of appetite, nausea, severe fatigue, congestion
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| 62 | 2021-01-17 | abdominal pain |
Feel like , I have a cold or allergies, Lower back pain, Abdominal Pain One Knee was shaking right a...
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Feel like , I have a cold or allergies, Lower back pain, Abdominal Pain One Knee was shaking right after vaccine Full body pain daily mostly in the lower back
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| 62 | 2021-01-17 | nausea |
PT received second injection on 1/13/2021 and had significant side effects following the second vacc...
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PT received second injection on 1/13/2021 and had significant side effects following the second vaccine. 24 - 48 hours of low grade fever, severe nausea, headache, fatigue and body aches.
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| 62 | 2021-01-18 | diarrhea, abdominal discomfort |
fever(99), and chills,, stomach upset and diarrhea--also reporting a new cough that developed after ...
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fever(99), and chills,, stomach upset and diarrhea--also reporting a new cough that developed after the vaccine HX of Multiple Sclerosis
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| 62 | 2021-01-18 | nausea |
Reported PM post vaccine she had fever, malaise, headache, left axilla swelling, "pleurisy" feeling ...
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Reported PM post vaccine she had fever, malaise, headache, left axilla swelling, "pleurisy" feeling in chest. No sob. Early on 1/8/21 in the AM, had 2 runs afib, that responded to metoprolol. She reported the afib to her cardiologists. Called again on 1/19/21 to report continued fevers, fatigue, body aches, nausea, and chills that caused her to call off on 1/17/21. Ordered COVID-19 PCR.
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| 62 | 2021-01-18 | nausea |
Pfizer -BioNTech Covid-19 Vaccine EUA After the vaccine I developed headache, low grade fever, muscl...
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Pfizer -BioNTech Covid-19 Vaccine EUA After the vaccine I developed headache, low grade fever, muscle ache, stiffness and nausea. This felt positive for the first 3 days until the symptoms did not leave and remained for 9 days post vaccination.
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| 62 | 2021-01-19 | nausea |
Reported PM post vaccine she had fever, malaise, headache, left axilla swelling, "pleurisy" feeling ...
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Reported PM post vaccine she had fever, malaise, headache, left axilla swelling, "pleurisy" feeling in chest. No sob. Early on 1/8/21 in the AM, had 2 runs afib, that responded to metoprolol. She reported the afib to her cardiologists. Called again on 1/19/21 to report continued fevers, fatigue, body aches, nausea, and chills that caused her to call off on 1/17/21. Ordered COVID-19 PCR.
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| 62 | 2021-01-20 | abdominal pain upper |
"pains in my stomach on the left side from under my breast to my umbilicus. they are not intestinal,...
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"pains in my stomach on the left side from under my breast to my umbilicus. they are not intestinal, but more superficial. It is a general soreness with periodic stabbing pains." --still continuing after 5 days post vaccination
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| 62 | 2021-01-20 | diarrhea | 7 loose stools overnight. Symptoms resloved |
| 62 | 2021-01-20 | difficulty swallowing |
~ 10 minutes after vaccine, patient started c/o chest tightness and SOA. Pulse ox was 95%, BP 204/7...
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~ 10 minutes after vaccine, patient started c/o chest tightness and SOA. Pulse ox was 95%, BP 204/79, P-83. Patient stated that she experienced same symptoms when she went to ED for chest pain and was given Morphine. At 10:04 AM Patient was given Pepcid 20 mg, Benadryl 25 mg, and Zyrtec po. She had difficulty swallowing those pills. Lung sounds clear. Oriented X3. EKG was normal. After about one hour of observation with no relief, she was transferred to UKED. BP was 131/50, P-97 and Pulse ox 98% just prior to transfer.
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| 62 | 2021-01-21 | nausea | HAD FATIGUE AND NAUSEA |
| 62 | 2021-01-22 | nausea, abdominal pain | SEVERE abdominal pain, fever, nausea, |
| 62 | 2021-01-23 | abdominal discomfort |
Starting on the 16th of Jan I became very sick to my stomach.This lasted the the AM on the 18th no o...
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Starting on the 16th of Jan I became very sick to my stomach.This lasted the the AM on the 18th no other syptoms present. I left work at 8:00am on the 18th with no fever ( I checked three times during the midnight shift ) I went home to bed and woke up at 6:00pm with 100.8 fever ( I never run a fever ) had fever chills and joint pain in the upper body no respiratory issues .Within 48 hours the fever was gone as well as the chills but I continued to be sick to my stomach for another two days.I wanted to report this delayed reaction because of my underlying HIV and given the fact no individuals with HIV were included in the initial study. I tested negative with the nasal swab test on the 20th.
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| 62 | 2021-01-23 | nausea |
Pt began to have tightness in throat, heart palpitations, nausea after 10 minutes past administratio...
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Pt began to have tightness in throat, heart palpitations, nausea after 10 minutes past administration of vaccine. Approx 5 min later noted color change in lips.
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| 62 | 2021-01-24 | diarrhea | Diarrhea, headache, and body aches next day, 1/15/21. |
| 62 | 2021-01-24 | gastrointestinal disorder, flatulence |
Unable to get out of bed: She is so sleepy and has no energy; Wiped out of energy; lots of flatulenc...
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Unable to get out of bed: She is so sleepy and has no energy; Wiped out of energy; lots of flatulence; Chills; Joint pain; Lower GI symptoms; she is also feeling cold; This is a spontaneous report from a contactable nurse (patient). A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT#: GL3248 (Caller said that the G may be an E.)), via an unspecified route of administration in the left arm on 07Jan2021 at second single dose for working with cancer patients. Medical history included ongoing diabetic and ongoing hyperthyroidism, both diagnosed about 6 years ago and were under control. There were no concomitant medications. Historical vaccine included BNT162B2 on 18Dec2020 for working with cancer patients (First dose, lot number: EJ1685, injection in the left arm). On 11Jan2021 the patient had chills, joint pain, and lower GI symptoms. Her lower GI symptoms included diarrhea. Then caller clarified that it was not diarrhea but the urge to go. The stools were solid. She also had lots of flatulence. She was also wiped out of energy, around like 2 PM on 11Jan2021 she went up a flight of stairs and was so exhausted. The patient is a nurse. She was in her office that day and had to literally lay on the floor because she was so wiped out of energy. She left work early and went to bed. Then the next day 12Jan2021, she was unable to get out of bed the whole day. She is so sleepy and has no energy. She went to bed last night at 08:30, but is still so sleepy. Today she is feeling better, but still had lower GI symptoms. She was also feeling cold, which she normally is always hot. She was having to put 5 blankets on her. Outcome of the event chills was recovered on 12Jan2021, of events joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed was recovering, of events flatulence and feeling cold was unknown. The reporter considered the event chills, joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed as serious (disability) and related to BNT162B2.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported chills, joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed and the administration of the COVID 19 vaccine, BNT162B2, given the plausible temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 62 | 2021-01-24 | nausea, abdominal pain upper | Wheezing, chest tightness, dizziness, stomach cramps, nausea |
| 62 | 2021-01-24 | nausea, vomiting |
Nearing 24 hours after receiving my second vaccine, I began to feel ill, similar to an intestinal f...
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Nearing 24 hours after receiving my second vaccine, I began to feel ill, similar to an intestinal flu coming on, weak and dizzy. I felt that way for approximately 20 minutes and went lie down but began to feel more dizzy and then very nauseated. I then vomited several times and afterward began to feel steadily better. The whole even was approximately 2 hour before I felt back to normal.
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| 62 | 2021-01-24 | nausea |
minutes after injection started reacting with, palpitations, shortness of air and nausea. went to Ed...
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minutes after injection started reacting with, palpitations, shortness of air and nausea. went to Ed and received IM epi\listed vaccine as allergy
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| 62 | 2021-01-24 | vomiting, nausea | She is having intense nausea and vomiting. She went to the emergency room today. |
| 62 | 2021-01-25 | decreased appetite |
runny nose; slight cough; Lethargy; very tired; no appetite; Severe body aches; chills; fever; my ly...
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runny nose; slight cough; Lethargy; very tired; no appetite; Severe body aches; chills; fever; my lymph nodes under my injection arm became swollen and sore; my lymph nodes under my injection arm became swollen and sore; This is a spontaneous report from a contactable other HCP (patient). A 62-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: 0140) intramuscular in right arm on 11Jan2021 15:30 at single dose for COVID-19 immunization. She received the first dose of BNT162B2 (lot number: 0140) intramuscular in left arm on 21Dec2020 16:15 for COVID-19 immunization. Medical history included Sulfa and PCN allergy. There was no other medical history. There was no concomitant medications. There were no other medications in two weeks, no other vaccine in four weeks. The patient experienced severe body aches, chills, and fever starting approximately 8-10 hours after vaccine on 11Jan2021. These symptoms were accompanied by a runny nose and slight cough on 12Jan2021 08:00. Lethargy, very tired, no appetite also on 12Jan2021 08:00. Symptoms resolved with Tylenol, Nyquil, and one day of deep sleep. On the second day (Jan2021), her lymph nodes under her injection arm became swollen and sore. Patient is not pregnant. Events were recovered on Jan2021.
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| 62 | 2021-01-25 | vomiting | ON 1/20/21 DEVELOPED FATIGUE, CONFUSION, AND VOMITING. FOLLOWED UP WITH PCP. |
| 62 | 2021-01-26 | diarrhea, nausea |
Had 2nd shot on Tuesday 1/19 at 1500. Went to bed felt a little nausea, woke at 0300 1/20 with runs....
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Had 2nd shot on Tuesday 1/19 at 1500. Went to bed felt a little nausea, woke at 0300 1/20 with runs. Finally back to bed to continue with violent shakes. fever, aches and head aches lasting until late Thursday afternoon. Exhausted feeling still remaining through Saturday. Felt myself on Sunday 1/24
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| 62 | 2021-01-27 | difficulty swallowing |
approximately 10 minutes after receiving vaccine patient complained of fullness in throat and diffic...
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approximately 10 minutes after receiving vaccine patient complained of fullness in throat and difficulty swallowing, also felt tremulous and like heart was racing, some visible swelling of lower lip, initial vitals revealed pulse ox of 99, bp 151/70 and hr of 107, lungs clear without wheezing, no urticaria, given 25mg po Benadryl with gradual resolution of symptoms and normalization of vital signs
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| 62 | 2021-01-27 | retching |
approx. 15-20 min after vaccine admin, pt c/o "ha, fatigue", evaluation by EMT, vs 158/86 100, spo2 ...
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approx. 15-20 min after vaccine admin, pt c/o "ha, fatigue", evaluation by EMT, vs 158/86 100, spo2 97, p=101, pt reports that this bp is "normal for her", she remained alert aned oriented, progressed to feeling "flushed from head to waist", at 5:05 pm, pt feels that these s/s r/t "very busy all day,this is the first time I have sat down all day", bp 168/95, 103, spo2 96, cool pack applied to back of neck, pt reports increase in feeling , "flushed", 1720- pt c/o "my neck feels swollen, my jaw hurts", denies shortness of breath, or chest pain, no hives observed on head, or abd, pt agrees to more advanced eval at ER, husband notified, 1730, pt experiences dry heaves, no emesis, bp 179/109, Ambulance called to transport to ER, IV initiated by EMT, 1740, pt to stretcher, with ambulance crew, report given, pt continues to deny shortness of breath, and chest pain, she remains alert and oriented.
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| 62 | 2021-01-28 | burping |
Headache, HYPERtension, FATIGUE Narrative: PATIENT HOSPITALIZED OVERNOC w/HTN urgency. patient late...
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Headache, HYPERtension, FATIGUE Narrative: PATIENT HOSPITALIZED OVERNOC w/HTN urgency. patient later seen by PCP endorsing improvement of symptoms. pt further endorsed feeling lightheaded with vaccination # 1. pt also with c/o increased burping.
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| 62 | 2021-01-29 | nausea |
Patient is a 60-year-old female with past medical history of HTN, SLE presents emergency department ...
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Patient is a 60-year-old female with past medical history of HTN, SLE presents emergency department with throat itching after receiving the COVID-19 vaccination. Patient states that she previously had allergic reaction to contrast dye in the past and is having a similar sensation in her throat. She admits to nausea but denies any voice changes, difficulty swallowing, wheezing, rash. Patient denies requiring admission recommendation from allergic reaction past. Patient received Allegra prior to receiving the vaccination. This is her first dose of the vaccination.
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| 62 | 2021-01-30 | abdominal discomfort |
Early afternoon - Tiredness- 7-8 pm Fever of 99; Muscle/joint aches/pains; Upset stomach; stuff nose...
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Early afternoon - Tiredness- 7-8 pm Fever of 99; Muscle/joint aches/pains; Upset stomach; stuff nose Later in evening - hives Next morning - swollen lip on left side (had derm filler on 1/21/2021) Took Tylenol and Benadryl
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| 62 | 2021-01-31 | abdominal discomfort |
Pain swelling redness at injection site. Dizziness, Body Aches. headache stomach distress, tired...
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Pain swelling redness at injection site. Dizziness, Body Aches. headache stomach distress, tiredness
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| 62 | 2021-01-31 | abdominal pain upper, nausea |
(Friday)Immediately after the injection-dizziness, vertigo, tunnel vision, blurred vision, pin point...
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(Friday)Immediately after the injection-dizziness, vertigo, tunnel vision, blurred vision, pin point pupils, unable to talk, headache, facial and lip numbness, numbness traveled down the right side of my body (side of injection) trembles, weak legs, very weak all over. EMTs were called but I didn't go to the hospital. My son picked me up and took me home because I was unable to drive. On the way I experienced loss of vision and speech for about 5 minutes. When I got home, my legs were so shaky that I had to have help walking. I started getting severe chills that took 3 hours to get warm (2 heavy blankets, space heater, and heating pad). I was very fatigued and felt bad the rest of the day. (Saturday)The next day I had flu-like symptoms; headache, joint aches, chills, nausea, extreme fatigue. Sunday was better but still had to rest most of the day because when I would stay up for over 30 minutes, the symptoms would return. Monday- stomach cramps, headache, fatigue but went to work (30 minutes late due to stomach) and left 30 minutes early.
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| 62 | 2021-01-31 | decreased appetite |
she was injected, sh stopped eating and talking, the doctor watched her for 2 days. had her transpor...
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she was injected, sh stopped eating and talking, the doctor watched her for 2 days. had her transported to the hospital. i was told she had tested positive for COVID 2 times once at the home and once at the hospital. with in 2 DAYS at the hospital she wa on a ventilator 2 days later she died. i talked with the rehab center and confirmed she tested negative for COVID on Dec 27th 2020 and was given the Vaccine on the 29th Dec 202 was in the hospital 4 day later, was on a ventilator 4 days after that then died a few day later as her heart stopped beating. all the while i had POA and was not contacted by Hospital staff until after they had made the next step.
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| 62 | 2021-01-31 | difficulty swallowing |
I had to get cleared by a allergist prior to getting the vaccine due to my prior history allergy his...
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I had to get cleared by a allergist prior to getting the vaccine due to my prior history allergy history. I was advised by the allergist to take Allegra an hour before receiving the vaccine. About 10 minutes after receiving the vaccine, I started to throat my started to feel dry and tickling, it felt like it swelling starting from the left side to the center, I started having difficulties swallowing my salvia and any fluid. My blood pressure was checked and it was elevated. I started to have difficulty breathing. They transferred me over to the ER. They gave me IV medicines Benadryl, Prednisone, Pepcid (I think). After 6 hours I was able to go home. Everything went back to normal besides the pain in the left arm at injection site. I had a telemedicine visit today with my primary care physician to follow up.
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| 62 | 2021-01-31 | nausea | chills, aching, headache, slightly nauseous, low grade fever |
| 62 | 2021-01-31 | nausea | Systemic: Anaphylaxis-Severe, Systemic: Exhaustion, Systemic: Nausea |
| 62 | 2021-02-01 | nausea, abdominal pain |
pressure across chest; eyes were very swollen; flu symptoms; severe aches/ Pain radiated bilaterall...
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pressure across chest; eyes were very swollen; flu symptoms; severe aches/ Pain radiated bilaterally up neck, mandibular area, trigeminal and into head; abdominal pain; nausea; Injection site very painful, could not touch; This is a spontaneous report from a contactable nurse reported for herself. This 62 Years old patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular on 12Jan2021 13:15 on Arm left at single dose (Lot # EL0142) for covid-19 immunisation. Medical history included hashimoto disease, allergies to maxide. Prior to vaccination, was the patient did not diagnose with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID), valsartan, Pravastatin, docusate sodium (COLACE), wool fat (EUCERIN) and Vitamin D Nos. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular on 22Dec2020 13:15 on Arm left at single dose (Lot # EK5730) for covid-19 immunisation. The patient woke up 13Jan2021 at 2:00 AM with flu symptoms - severe aches, abdominal pain and nausea. By 13Jan2021 4:30 eyes were very swollen. Slept 14 hours. Next night 14Jan2021 at 1AM, severe arm pain radiating across chest to other armpit - pressure across chest. Pain radiated bilaterally up neck, mandibular area, trigeminal and into head. Injection site very painful - could not touch in Jan2021. As the pain at injection site subsided - so did the symptoms. Events were non serious. No treatments were received. On 15Jan2021, laboratory details included nasal swab which showed negative. Outcome of the events was recovered.
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| 62 | 2021-02-01 | nausea |
Nausea, fever , aches and pains all over , flu like symptoms , Rash from chin to chest , itchy . st...
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Nausea, fever , aches and pains all over , flu like symptoms , Rash from chin to chest , itchy . still have itchy neck chin to chest.
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| 62 | 2021-02-01 | nausea |
Second vaccine given on 1/28/21. Got sick later that evening with pain & soreness at the injection s...
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Second vaccine given on 1/28/21. Got sick later that evening with pain & soreness at the injection site. Along with a severe headache, nausea, and chills. The symptoms lingered over the next couple of days. Contacted Employee Heath and manger the following day. Stayed out of work on 1/29/21.
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| 62 | 2021-02-02 | nausea, vomiting | Rash on trunk of body with nausea and vomiting x48 hours |
| 62 | 2021-02-03 | nausea, vomiting |
19 hours post vaccination, sudden onset of dizziness and nausea, 1 episode of vomiting. Dizziness pe...
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19 hours post vaccination, sudden onset of dizziness and nausea, 1 episode of vomiting. Dizziness persisting.
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| 62 | 2021-02-03 | nausea |
Patient with headache, muscle aches, nausea. then developed palpitations and dull constant nonexert...
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Patient with headache, muscle aches, nausea. then developed palpitations and dull constant nonexertional chest ache for several hours resolved with fluids and Tylenol/motrin.
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| 62 | 2021-02-03 | nausea |
101.5 fever for approx. 30 hours; severe headache with light sensitivity for days 1-5; severe headac...
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101.5 fever for approx. 30 hours; severe headache with light sensitivity for days 1-5; severe headache with light sensitivity for days 1-5; muscle cramps; joint pain; nausea; extreme fatigue lasting several days.; This is a spontaneous report from a contactable Other Health Professional (HCP) (patient). A 62-year-old female patient (pregnant: No) received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Lot number: EL0140), via unspecified route of administration on left arm on 12Jan2021 at 10:00 AM at single dose for covid-19 immunisation. The relevant medical history included Rheumatoid Arthritis, Asthma, Hypertension, Multiple allergies, Peripheral Neuropathy, degenerative disc disease, known allergies: Sulfa drugs; Tetracycline; Nsaids; Aspirin; Ioxinol; multiple pollens & molds; capsicum, peppers, black tea, black cohosh, and more. Concomitant medications included valsartan (DIOVAN), adalimumab (HUMIRA), leflunomide, hydroxychloroquine phosphate (PLAQUENIL), montelukast sodium (SINGULAIR) and levocetirizine dihydrochloride (XYZAL). The patient previously received first dose of BNT162B2 at the age of 61 years old on 22Dec2020 (first dose, Lot number: EL1283, 03:00 PM, Left arm) for covid-19 immunisation. The patient experienced 101.5 fever for approx. 30 hours; severe headache with light sensitivity for days 1-5; muscle cramps, joint pain, nausea, and extreme fatigue lasting several days on 12Jan2021 at 04:00 PM. No treatment received for the events. No covid prior vaccination and no covid tested post vaccination. The outcome of the events was recovering.
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| 62 | 2021-02-03 | nausea |
Dizziness; nausea; headache; constant eye and nose drain; constant eye and nose drain; burning eye a...
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Dizziness; nausea; headache; constant eye and nose drain; constant eye and nose drain; burning eye and nose; burning eye and nose; weakness; tiredness; sore lips and throat; sore lips and throat; sore on tongue; chest tightness; This is a spontaneous report from a contactable consumer reporting for herself. A 62-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose at left arm on 14Jan2021 11:30 for Covid-19 immunisation, administered at hospital. Medical history included hypertension, high cholesterol, diabetes mellitus, allergies penicillin. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication within 2 weeks of vaccination included atenolol (manufacturer unknown), losartan (manufacturer unknown), atorvastatin (manufacturer unknown), hydrochlorothiazid (manufacturer unknown). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021 07:00 the patient experienced dizziness, nausea, headache, constant eye and nose drain, burning eye and nose, weakness, tiredness, sore lips and throat, sore on tongue, chest tightness. The patient underwent lab tests and procedures which included Sars-cov-2 nasal swab test: negative on 19Jan2021. The outcome of all events was not recovered as all ongoing now for 1 week. The events were considered non serious. Information on the lot/batch number has been requested.
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| 62 | 2021-02-04 | decreased appetite, diarrhea |
Called PCP, from the note: I got my shot on Jan 19. But last Friday I have been down with a horrible...
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Called PCP, from the note: I got my shot on Jan 19. But last Friday I have been down with a horrible flu. I'm wearing diapers because of uncontrollable diarrhea. I can't leave my sofa to walk over to my desk because I'll be so out of breath. I have a cough that produces a pink or gold Phelm I have dry mouth. I have no appetite I'm so weak and have lost 15 pounds. Don't know what to do. My next Covid is shot is feb 11 Called employer on 2/3/21 but hung up. Tried calling multiple times to follow up. In triage she stated she had a COVID test scheduled and had spoken with her PCP. COVID test through PCP: 2/4/21 She passed away the night of 2/4/21
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| 62 | 2021-02-04 | diarrhea |
Got injection Friday at 12 noon, Saturday morning woke up with fever 101.2, diarrhea x 12 hours, hea...
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Got injection Friday at 12 noon, Saturday morning woke up with fever 101.2, diarrhea x 12 hours, headache x 3 days (frontal) on Sunday developed a baseball size red, hard and warm to touch raised area around injection site. This lasted for 3 days
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| 62 | 2021-02-04 | nausea | soreness in arm, bad headache, nausea, itching on head, face and upper body. |
| 62 | 2021-02-05 | nausea |
Body Aches, headache, nausea, dizzy ness, feeling unwell, fatigue Pfizer-BioNTech COVID-19 Vaccine E...
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Body Aches, headache, nausea, dizzy ness, feeling unwell, fatigue Pfizer-BioNTech COVID-19 Vaccine EUA
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| 62 | 2021-02-05 | vomiting |
Came on fast and furious Horrible Chills lasting about 3 hours, threw up about 20 times, sinus heada...
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Came on fast and furious Horrible Chills lasting about 3 hours, threw up about 20 times, sinus headache for a couple of days, low grade fever for about 12 hours , achy all over felt like pin pricks up and down my body to the bottoms of my feet. At one point my air passage felt blocked possibly by something that I threw up.. had trouble regaining my breath. I was surprised at how fast and furious this came on.
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| 62 | 2021-02-07 | nausea | lots of nausea , hot flashes, sore arm |
| 62 | 2021-02-07 | nausea |
Started to have weird body weakness sensation associated with mild nausea when I lay down at night. ...
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Started to have weird body weakness sensation associated with mild nausea when I lay down at night. Almost every night. As soon as I lay flat. Comes in waves. Causing me having problems falling asleep. Also happens when I tried to fall back to sleep. Mostly when I am about to fall asleep. During the day I am ok if I am upright. No fever or other symptoms. Getting insomnia from it every night.
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| 62 | 2021-02-07 | stomatitis | Headache, Fever chills times four days, mouth sores, swollen lymph nodes, joint pain, fatigue. |
| 62 | 2021-02-08 | nausea |
I was sitting in my sofa watching television and felt this odd dizziness overcome my head. I felt na...
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I was sitting in my sofa watching television and felt this odd dizziness overcome my head. I felt nauseated and hot. I closed my eyes for a few minutes and when I hope Ed the the intense dizziness subsided. I still feel a little dizzy, very tired and switch from feeling hot to very cold.
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| 62 | 2021-02-08 | nausea |
Pain at injection site; mild headache, body aches, nausea, (flu like symptoms). 400mg ibuprofen twic...
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Pain at injection site; mild headache, body aches, nausea, (flu like symptoms). 400mg ibuprofen twice 6 hours apart. Symptoms last 24 hours
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| 62 | 2021-02-08 | nausea |
heart rate of 160; severe nausea; arm soreness; muscle soreness in left arm; general fatigue; This i...
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heart rate of 160; severe nausea; arm soreness; muscle soreness in left arm; general fatigue; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283), via an unspecified route of administration on 21Jan2021 13:00 at single dose in left arm for COVID-19 immunisation. Patient age at time of vaccination was 62 years. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK5730) administered on 30Dec2020 at 01:00PM and the patient said she did not have a reaction after the first vaccine. The patient received no concomitant medications. She stated that she had no other recent vaccinations or new medications. One thing that may be important is that she did do a 7 day detox that ended the Sunday before her second vaccine dose, so her body was pretty much having no impurities in it, and she has been eating clean since then, maybe having something foreign put into her body set it off after detox. The patient experienced arm soreness and general fatigue on 21Jan2021, and on 22Jan2021 at 01:00 she experienced severe nausea and heart rate of 160 (which was reported serious as medically significant). Patient reported that after her second dose of the COVID-19 vaccine she had a significant side effect that didn't happen until 10-12 hours after getting the vaccine. She did not have a reaction after the first vaccine. After the second injection her arm was sore, and she had general fatigue. She had the second dose injected Thursday at around 01:00PM, then at one in the morning her heart rate was 160, and she had severe nausea. She was that way until 08:00AM. Her heart rate was 120 probably by 09:00AM, then came down to 100, she has never had anything like that before. Her arm soreness was a deep muscle soreness to her left arm. The fatigue was a couple hours later after she got the second dose of the vaccine. The nausea started at 01:00AM, and lasted until six to eight, she did no treatment, and it improved and is still gone now. For her heart rate of 160, she had no treatment, though she probably should have gone to the hospital, but it came down. She usually runs a heart rate of 60-70, it went back to normal Friday, probably in the afternoon on the 22nd, about 12 hours after that started. The patient stated that she feels this is medically significant for her heart rate to be that high. She had contacted her primary care physician (PCP), but they didn't call her back for 4-5 hours, by then she was fine. She doesn't think that this was treated well by her PCP, and that they should have done an electrocardiogram (EKG) and follow up labs, she is changing her PCP as a result of this. She is concerned about the people who will be getting their second dose, she has been helping with these, they have patients that are over 100, they wouldn't survive that rapid heartbeat. The outcome of arm soreness/muscle soreness and fatigue was unknown.; Sender's Comments: The reported event of heart rate increased was likely causally related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 62 | 2021-02-09 | vomiting, nausea |
Moderate to severe fatigue; moderate nausea; slight joint pain; Vomiting; Dose 1 administration date...
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Moderate to severe fatigue; moderate nausea; slight joint pain; Vomiting; Dose 1 administration date 21Dec2020, Dose 2 administration date 07Jan2021; severe underarm pain; moderate chills; shaking; severe migraine-like headache; This is a spontaneous report from a contactable other health professional reporting for herself. A 62-year-old female patient received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number: EK4176), via an unspecified route of administration on 07Jan2021 10:30 AM at single dose in Right arm for COVID-19 immunisation. Medical history included IV dye allergy and Allergy when on antibiotics from an unknown date. Concomitant medication included acetylsalicylic acid (ALKA SELTZER) received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number: EL0140) on 21Dec2020 10:30 AM in Right arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced vomiting 12 hours after second injection on 07Jan2021 at 10:30 PM, then severe underarm pain and moderate chills and shaking 14 hours after, then severe migraine-like headache and slight chills 22-26 hours after. Moderate to severe fatigue, moderate nausea, slight joint pain for another 2 days, on 10Jan2021. Third day after injection was slight nausea and moderate fatigue. Fourth to sixth day after injection was slight fatigue. Since the vaccination, the patient has not been tested for COVID-19. Treatment was not received for the adverse event. The outcome of events was recovered. The case was reported as non-serious.
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| 62 | 2021-02-10 | decreased appetite | Chills, Fever, Fatigue, slight headache, loss of appetite It only lasted one day |
| 62 | 2021-02-10 | vomiting |
woke up not feeling good; a few hours later headache and dizzy; dizziness increased; driving and ha...
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woke up not feeling good; a few hours later headache and dizzy; dizziness increased; driving and hard to keep eyes open; feeling overall sick and getting very hot; threw up quickly three times water only nothing in my stomach. Got home and went to bed and slept for a few hours. Woke up and felt better. Headache and fatique so rested the day; next day felt better with headache and rested. Third-day slight headache but felt much better.
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| 62 | 2021-02-11 | nausea |
Injection site soreness and dark red circle for 3 weeks Severe chills 4 days Dizziness Headache Naus...
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Injection site soreness and dark red circle for 3 weeks Severe chills 4 days Dizziness Headache Nausea
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| 62 | 2021-02-14 | diarrhea | headache, fever, fatigue, diarrhea, |
| 62 | 2021-02-14 | nausea, diarrhea |
pain at site of injection at 24 hours post injection. Nausea, diarrhea, headache 24 through 48 hours...
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pain at site of injection at 24 hours post injection. Nausea, diarrhea, headache 24 through 48 hours post injection.
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| 62 | 2021-02-14 | nausea | Extreme fatigue, chills, headache, joint and muscle aches, nausea. |
| 62 | 2021-02-15 | abdominal pain, nausea | Body aches, severe abdominal cramping, nausea |
| 62 | 2021-02-15 | nausea |
Developed typical flu symptoms but developed severe incapacitating migraine/nausea/photofobia/vertig...
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Developed typical flu symptoms but developed severe incapacitating migraine/nausea/photofobia/vertigo. Felt feverish but no temp. Severity so bad almost went to ER. Took Imitrex x2 with chest tightness occurring after 2nd dose. Lasted x3 days then pressure on right side of head eye for a month. Elected not to do 2nd shot due to above s/s.
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| 62 | 2021-02-17 | vomiting |
The site got worse through Thursday and was red, hot; Weakness; woke up with 100.5 degrees temperatu...
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The site got worse through Thursday and was red, hot; Weakness; woke up with 100.5 degrees temperature; Difficulty remembering things; Vomiting; Headache 10/10; developed a red area below injection site/The site got worse through Thursday and was red, hot; This is a spontaneous report from a contactable nurse. A 62-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular in right deltoid on 24Jan2021 at a single dose for prevention (COVID-19 immunization). Medical history included Low immunoglobulin/compromised immune status/Low immunoglobulin diagnosed 8 years ago, hereditary angioedema from 2010, asthma diagnosed in her 20's, Allergic to Thermarisol, diagnosed allergies, respiratory illness, and endocrine abnormalities (including diabetes) and obesity. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (LOT number: EJ1686) in right deltoid on 03Jan2021 for covid-19 immunization, and flu shot on Sep2020 without adverse event. She got second injection on 24Jan2021. On 25Jan2021, she woke up with 100.5 degrees temperature and could not stop vomiting. She had to go to the ER. They gave her Zofran, IV and also Toradol because she had a number 10 headache. She continued with low grade temperature throughout week from 99.5-100.5 degrees Fahrenheit, and by Tuesday morning, she developed a red area below injection site. By Thursday, there was a red area growth to 13 cm x 15.5 cm on the injection site. She could not remember her email address and said her brain was not thinking. This started after the vaccine that she began having difficulty remember things. She never had a headache that bad. It improved but she has a lingering headache still. She continued to have a temperature from Monday to Saturday. Currently, she does not have an elevated temperature. Difficulty remembering things was reported as just irritating, but significant. The site got worse through Thursday and was red, hot and ended up measuring 13 cm x 15.5 cm. Regarding weakness, she could walk but medics had to help support from her seat to the ambulance. The outcome of the events red and hot injection site was not recovered; the outcome of the events vomiting, headache, weakness was recovering. The outcome of difficulty remembering things was unknown. The outcome of high temperature was recovered on an unknown date. The events was assessed as medically significant.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported events and the use of BNT162B2 cannot be excluded. The case will be assessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.
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| 62 | 2021-02-18 | nausea, abdominal pain upper, decreased appetite |
Fever, headache, dizziness, muscle and join pain/aches - at time severe, hives, nauseous/stomach ach...
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Fever, headache, dizziness, muscle and join pain/aches - at time severe, hives, nauseous/stomach ache similar to indigestion, loss of appetite, injection site pain, fatigue
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| 62 | 2021-02-18 | vomiting |
I woke up with runny nose and constant sneezing, muscle aches and pains. Fever 103 and chills and un...
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I woke up with runny nose and constant sneezing, muscle aches and pains. Fever 103 and chills and uncontrollable vomiting. Suspects cerebral edema because of head ache and vomiting. Took 8 mg of dexmetholzone and Zofran. Neither were helpful. I took a shot of emetrex in case of a migraine. Vomiting has stopped but fatigue and weakness persists.
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| 62 | 2021-02-18 | vomiting |
Patient received second dose of Pfizer vaccine and after about 20 minutes of receiving dose began to...
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Patient received second dose of Pfizer vaccine and after about 20 minutes of receiving dose began to feel dizzy and vomit. Heart rate slightly elevated. Patient was taken to emergency room for further evaluation.
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| 62 | 2021-02-21 | vomiting |
01/23 Hives began on thigh and progress to arms, torso, underarms and then both thighs. 01/25 Calle...
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01/23 Hives began on thigh and progress to arms, torso, underarms and then both thighs. 01/25 Called dr and had a Telemed call with NP on Tues. 01/26. Predisone and Benadryl was prescribed. Thurs. 01/28 Call to let them know that it wasn?t working. I went into the office for one shot of Solumedrol. This help and they were gone. They gave me second dose of Predisone to take in case it came back and to continue the Benadryl. 02/8 Second vaccine. Hives began that night: arms, torso, thighs, hair. Call the Dr. on 02/10 and suggested I go to an allergist. Went to allergist on 02/11 she said to only take one Predisone, Allegra one am and one at noon, then take zertek at nighttime. The Predisone created a major brain fog, I had to stop. Saw the allergist on 2/18, she agreed to get off the Predisone. 02/11 I passed out in the am and when I woke up with vomit running down my face. Still suffering with hives this entire time. 02/17 my face, lips, tongue started to swell and I had chest pain for 90 minutes. My feel swelled and I have hives so bad on my feet I could not walk or put on shoes. 02/20 Woke up with sweat on my chest. My hands were so swollen I had to have my wedding ring was cut off . 02/21 I went to the Urgent Care and received a shot of Solumedrol. They said this should last me for a few days. 02/21 woke up 3 time throughout the night soaked in sweat.
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| 62 | 2021-02-22 | nausea, vomiting | Fever (103+), vomiting, chills, headache, nausea, sweating, fatigue for 36+ hours. |
| 62 | 2021-02-23 | vomiting |
2/3/21: c/o Fever, headache and vomiting; 2/3/21 at 7am: Fever escalated; 2/4/21: Temp: 104; admit...
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2/3/21: c/o Fever, headache and vomiting; 2/3/21 at 7am: Fever escalated; 2/4/21: Temp: 104; admitted to hospital; Dx: HSV-1, Encephalitis; Tx: Acyclovir IV TID x 3 weeks, completes tx on 2/25/21 Admitted total of 6 days 2/10/21: discharged home, continues to have difficulty with computation of numbers and naming objects
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| 62 | 2021-02-24 | nausea, abdominal pain lower |
I have chronic left lower quadrant pain/inflammation due to prior abdominal surgeries. My doctors ha...
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I have chronic left lower quadrant pain/inflammation due to prior abdominal surgeries. My doctors have told me it is scar tissue/adhesions. I have flare ups periodically. This has been going on for more than 15 years. I have not had a major flare up in more than 2 years. I received the second dose on 2.10. I had mild flu like symptoms in the next 24 hrs. On 2/16 I began to feel like I was going to have a flare up. The pain progressed to constant. It was the worst flare up of this left lower quadrant pain I have had in YEARS! I had to call my MD and ask for pain medications. I was nauseous as well. The pain slowly began to subside and by 2/23 I was back to normal. The ONLY thing different in my life has been the vaccine.
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| 62 | 2021-02-24 | nausea, decreased appetite |
persistant nausea/nausea become much worse on day 4; fatigue; slight appetite loss; unable to eat no...
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persistant nausea/nausea become much worse on day 4; fatigue; slight appetite loss; unable to eat normally; lost much weight; This is a spontaneous report from a contactable consumer reported for herself. A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EM980) , on 04Feb2021 at 16:00 (at 62 years) at single dose in left arm for covid-19 immunisation . Medical history included glucose intolerance. Patient was not pregnant.Concomitant medication included atenolol and calcium/ergocalciferol (CALCIUM/VITAMIN D). The patient previously took sulfamethoxazole/trimethoprim (BACTRIM) and experienced allergy. On 08Feb2021 at 08:00 (as reported) the patient experienced persistent nausea, fatigue, slight appetite loss, unable to eat normally and lost much weight, all non serious. Events were described as follows: patient had persistent nausea. The first few days she had the expected side effects of fatigue and slight appetite loss. The fatigue resolved on the second day, but the nausea become much worse on day 4. She had been unable to eat normally since then and had lost much weight that she cannot afford to lose. She kept hoping that it will go away, but it was 8 days after her shot and she still had nausea (as reported). Anti nausea medicine was administered, no treatment given for the other events. Patient recovered from fatigue in Feb2021; outcome of the other events was not recovered.
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| 62 | 2021-02-24 | nausea | low grade fever first 2 days, continued off and on nausea, dizziness and confusion |
| 62 | 2021-02-25 | diarrhea, nausea |
body ache, head ache, nausea, diarrhea, weakness, muscle pain, moving body pain, food intolerance, t...
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body ache, head ache, nausea, diarrhea, weakness, muscle pain, moving body pain, food intolerance, thirst, shaking, feeling of crawling out of body. Lasted 3 1/2 days. Last 2 days shaking and crawling out of body feeling was not present. Diarrhea only day 1. Nausea lasted 1 1/2 days. Day 4 no adverse effects remained. Not certain if the above was related to vaccine but timing seemed to match.
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| 62 | 2021-02-26 | abdominal pain upper |
For about 20 minutes I experienced severe belly pains, profuse sweating and cold and clamminess, my ...
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For about 20 minutes I experienced severe belly pains, profuse sweating and cold and clamminess, my temperature dropped to 93 degrees. When I finished with these symptoms my temperature climbed back up to 97.7. I have been having intermittent belly pains since then but they are nothing like they were last night and they are getting more mild and far between as I write this.
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| 62 | 2021-02-27 | nausea |
Sore arm, nausea, with in an hour of vaccine. fever 100.6 started couple hours later treated with...
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Sore arm, nausea, with in an hour of vaccine. fever 100.6 started couple hours later treated with Tylenol
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| 62 | 2021-02-27 | nausea | ?Pfizer-BioNTech COVID-19 Vaccine EUA nausea vertigo |
| 62 | 2021-02-27 | vomiting, nausea | Chills, fever, nausea, vomiting, and severe headache |
| 62 | 2021-03-01 | decreased appetite |
PT reported feeling dizziness, anxiety, and BP was 130/106 when reporting she did not he a hx of ele...
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PT reported feeling dizziness, anxiety, and BP was 130/106 when reporting she did not he a hx of elevated blood pressure. Pt reported not eating anything all day except for two oranges. Pt reported feeling the room was "spinning". Pt given snack of granola bar, then rice crispies, and finished a juice box and a small water bottle. Pt was able to ambulate unassisted to bathroom at 1545. Pt called her husband to pick her up, and pt left with husband at 1555. Pt denied symptoms at that time.
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| 62 | 2021-03-03 | diarrhea |
Within an hour, I started getting a dry throat and had a dry cough for a few days. A little breathin...
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Within an hour, I started getting a dry throat and had a dry cough for a few days. A little breathing problem - it was almost like my reaction to bees that I had before - where my throat was closing up but that was just for about an hour. The second day, I had also (three days) of really bad diarrhea.
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| 62 | 2021-03-03 | nausea |
Patient was complaining of increased heart rate and nausea about 20 minutes following the vaccine....
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Patient was complaining of increased heart rate and nausea about 20 minutes following the vaccine. Patient also mentioned she had just had blood work done that morning before coming to get her vaccine so the pharmacy staff gave her some bottled water. Patient requested an ambulance and wanted to be transported.
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| 62 | 2021-03-04 | diarrhea | Diarrhea for 2 days after vaccine on 3/3/2021. |
| 62 | 2021-03-05 | abdominal discomfort |
15-20 after vaccine was administered I felt very confused and couldn't remember where I put my card,...
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15-20 after vaccine was administered I felt very confused and couldn't remember where I put my card, my pocketbook, felt pretty disoriented. I remember someone telling me to sit down and eat something. (I had already had lunch and a snack). That evening I started to have a bad headache. Thursday morning I had a very difficult time getting up and was extremely fatigued; felt hot. I felt exhausted all day and looked pretty tired and pale. Friday morning still tired, had some bouts of energy, but they didn't last long. Body aches were worse and I also had some stomach discomfort Saturday felt like I had a sore throat, felt weak, and still pretty tired. I had some problems catching my breath when climbing stair and and at one point felt hot and clammy. Headache was better.
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| 62 | 2021-03-05 | decreased appetite |
On day 10 I woke with achey shoulders, neck and hands. Later in day had mild chills and overall ache...
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On day 10 I woke with achey shoulders, neck and hands. Later in day had mild chills and overall aches and by evening had 101.5 temp and flushing of face along with mild headache. Tylenol taken along with warm shower and early bed. Woke in am with mild headache, loss of appetite. Felt better by 11am and after a cup of tea. By afternoon I felt 100% back to normal. No rashes or even a sore arm post vaccination in the days prior to this event on day 10.
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| 62 | 2021-03-05 | diarrhea, abdominal pain upper, vomiting | Vomiting, dizziness, stabbing lower stomach pain, exhaustion, diarrhea. |
| 62 | 2021-03-06 | nausea | First day rash/ hives and headaches with fatigue Continue to aches, fever, headaches and nauseated |
| 62 | 2021-03-07 | nausea |
Saturday evening injection sight started hurting. Woke up Sunday morning to nausea, dizziness, chil...
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Saturday evening injection sight started hurting. Woke up Sunday morning to nausea, dizziness, chills, muscle and joint pain, headache, tiredness
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| 62 | 2021-03-07 | vomiting | Vomiting, and other flu-like symptoms |
| 62 | 2021-03-08 | decreased appetite, nausea |
Little chill; tired; felt like I have no energy/ My body feels so weak; slight pain on left arm/ my ...
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Little chill; tired; felt like I have no energy/ My body feels so weak; slight pain on left arm/ my hand started to pain a lot; I couldn't even touch my own self it was so sensitive; may be I'm inflamed; nausea; severe pain/ my waist my back is so painful; My body feels so weak; my fingers and hand; It triggered the shingles pain in my back; It triggered the shingles pain in my back; had no appetite, I didn't eat; She just checked her pressure and its was 130/80, and now, because of the pain, it went up a little bit; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982, expiration date: May2021), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. Medical history included shingles which she contracted in 2019, about one and a half years ago, it was a shingles on her back and lower back which she stated were the worst place for shingles has attacked, it left her with severe pain in both legs; diabetes; and high blood pressure. Concomitant medications included losartan, atenolol (a beta-blocker), and metformin for diabetes. The patient took the vaccine on 22Jan2021 and after about 2-4 days (Jan2021), she had a little chill and got very tired. She had to take care of herself. She was very tired not realizing it was the shot she took. She also felt like she has no energy. The patient was working from home but a lot of times, she was lying on the couch. Over the weekend (Jan2021), she had a slight pain on left arm. About a week or 8-10 days later (2021), she got very tired and couldn't even sit up. Her body was not itself. She started to feel like a bus rolling over her, like somebody took a baseball bat and beat her really bad. The patient uses her arm a lot and her hand started to feel a lot of pain. She couldn't even touch herself; it was so sensitive. She took paracetamol (TYLENOL) but it didn't work. She had celecoxib (CELEBREX) an anti-inflammatory, she thought she was maybe inflamed, but it didn't work. She had some diclofenac cream, she rubbed it, but it didn't work. The patient had shingles about a year and a half ago which was very bad. She just felt weak and didn't feel like herself anymore. She had a little bit of nausea and her whole body was really terrible. When she had the shingles, it left her with severe pain in both legs. She saw a neurologist and told her that she would have to take pregabalin (LYRICA) and it would go away. So, when she had severe pain last week, she took pregabalin but it didn't help. The patient took half of acetaminophen, oxycodone (PERCOCET) as she was not the person who takes pills, but it didn't work. Her body was so severe on Friday, it was not going away, the pain was there 24 hours. The patient has been experiencing this for 8-10 days now. She took one PERCOCET on Friday and had a slight relief and didn't took anything again. She kept rubbing the diclofenac cream, but it was not much of a relief. This morning, she has to work, she was sitting so she took PERCOCET. She is getting her second shot on Friday, 12Feb2021. She asked how she will feel after the second dose if she felt that way after the first dose, if the first shot was adequate, and if she should take the second dose. She stated that she didn't want to take the second dose. Her body felt so weak including her fingers and hand. It triggered the shingles pain in her back and felt like she was beaten up by someone. She has to lie down for the pain in her back. She also mentioned that she couldn't sit for so long as her waist and back were so painful. She was lying on a heating pad and ice and nothing was working. She even has a hard time getting up. She thought what happened was it triggered the shingles pain in her back and also left her with a problem under her feet. The shingles left her with some kind of damage when she took the shot. It was really bad. Her son was a physician and was concerned because last week, it got so bad, she didn't come out, she was in bed and bedridden from Friday to Sunday. She had no appetite, she didn't eat. The only thing that the patient had was diabetes and high blood pressure, but it was under control. She just checked her pressure and its was 130/80, and now, because of the pain, it went up a little bit, but before my pressure was like 120 something, over 68 or 72 it was always around the 60s and 70s. Since she was having this, it was a little high. The outcome of the events was unknown.
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| 62 | 2021-03-08 | decreased appetite | excessive fatigue, headaches, joint pain, loss of appetite, feeling unwell |
| 62 | 2021-03-08 | nausea, diarrhea |
Within minutes after receiving shot I became completely dizzy, lightheaded and started to faint. EMT...
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Within minutes after receiving shot I became completely dizzy, lightheaded and started to faint. EMT came to my aid and took vitals all looked OK. I stayed in place until I felt better about 30 minutes. For the rest of that day and the next day I was extremely tired, a little nauseous, and kind of out of it. The third day I had very sore left arm at site and very sore and tender lymph notes on left side of Arm and trunk. Six days after the shot I came suddenly down with a massive headache and diarrhea. Al has since resolved and I am on day eight.
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| 62 | 2021-03-08 | nausea |
The first reaction - 15 minutes after the vaccine - I felt really dizzy and loopy. She told me, I th...
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The first reaction - 15 minutes after the vaccine - I felt really dizzy and loopy. She told me, I think you better sit back down. I felt better after sitting there for 30 minutes after. I didn't get dizzy again. I finished my workday. Next morning, I woke up with a fever 100.8 (about). I woke up with sore muscles - I tend to get sore muscles easily but I felt more sore than normal and I had a headache. Fever stopped after 24 hours. Note: I also get dizzy really easily - and so it isn't difficult for something to make me dizzy. I also felt really tired. And over the weekend, I felt nauseated (not initially but over the weekend.) And that lasted until about midday Monday (over the weekend) to be getting better . I took Tylenol and I rested. That helped with the symptoms.
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| 62 | 2021-03-09 | nausea, diarrhea |
Three (3) days after receiving my second shot, I began to feel nauseous. Shortly after, diarrhea be...
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Three (3) days after receiving my second shot, I began to feel nauseous. Shortly after, diarrhea began and lasted for 24 hours. Then, I began to have the chills and a migraine-like headache. The migraine is still continuing past 24 hours.
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| 62 | 2021-03-10 | abdominal discomfort |
8:58AM: Vaccine administered 9:10AM: Reported tingling in fingers of right hand 9:19AM: Reported ti...
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8:58AM: Vaccine administered 9:10AM: Reported tingling in fingers of right hand 9:19AM: Reported tingling in fingers of right hand and burning of throat. CRNP notified and came to assess patient. Patient reported tingling in fingers of right hand but rest of right upper extremity felt fine. Having "upset stomach" and "throat soreness" which patient states she did not have prior to vaccine. She then stated her throat was burning. Able to drink water. Denied difficulty breathing or shortness of breath. Patient listed her allergies of Morphine and Percocet causing itching and scopolamine patch causing delirium. She reports taking all her prescribed medications this morning as well as 2 Tylenol. 9:29AM: Benadryl 25mg PO administered and patient continued to be monitored in observation area 9:44AM: CRNP reassessed patient and she stated she feels better and her throat was only sore and no longer burning 9:58 AM: CRNP reassessed. Patient states she is still feeling okay and would like to leave. MA walked with patient outside where patient got a taxi and was staying at her daughters house the rest of the day so she would not be by herself.
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| 62 | 2021-03-10 | abdominal pain |
Approximately 39 hours after immunization I woke with abdominal cramping. Upon standing I became li...
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Approximately 39 hours after immunization I woke with abdominal cramping. Upon standing I became light- headed and fell. My legs and arms turned red and warm and started itching. Itching subsided in an hour but redness remained for several hours. After itching stopped chills started and lasted several hours . By 7am symptoms were gone except for redness.
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| 62 | 2021-03-10 | diarrhea | extreme bone pain, diarrhea, insomnia |
| 62 | 2021-03-10 | nausea, diarrhea |
Dramatic flu symptoms. Extreme chills freezing cold extremities, fever, aches insomnia nose dischar...
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Dramatic flu symptoms. Extreme chills freezing cold extremities, fever, aches insomnia nose discharge, loose stools, headache, light nausea but did not vomit. Still not feeling well. Symptoms have decreased and can now sit in a chair as apposed to lying in bed.
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| 62 | 2021-03-10 | nausea | nausea, dizziness, weakness. Evaluated by EMS-Cleared |
| 62 | 2021-03-10 | nausea |
I lost muscle control while playing tennis for about 5 minutes. After that I felt very tired, queez...
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I lost muscle control while playing tennis for about 5 minutes. After that I felt very tired, queezy, dizzy for about two days.
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| 62 | 2021-03-11 | abdominal pain upper, nausea | fever (100.4), headache, fatigue, nausea, gastric pain |
| 62 | 2021-03-12 | nausea | Fever, aches, headache, nausea, chills |
| 62 | 2021-03-12 | nausea |
I received the 1st Covid vaccine dose on March 8 . Minor tenderness and fatigue 1st 2 days. Then on ...
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I received the 1st Covid vaccine dose on March 8 . Minor tenderness and fatigue 1st 2 days. Then on March 11 and still today, March 13, I have had tingliness on my face and chin and nausea. It seems to be getting worse and not better. I have been taking Benedryl. Is this normal or what should I do?
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| 62 | 2021-03-13 | diarrhea |
Same day mouth and throat swelling, rash appeared several days later, not getting betting with stero...
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Same day mouth and throat swelling, rash appeared several days later, not getting betting with steroids, Benadryl. Petechial rash diarrhea several days later.
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| 62 | 2021-03-14 | decreased appetite, abdominal discomfort |
Serious swelling and tenderness in arm pit and side, upper back, lymph nodes in neck and back of sk...
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Serious swelling and tenderness in arm pit and side, upper back, lymph nodes in neck and back of skull. upper chest and back of neck with horrible headache, Fever of 101.4, chills but major sweating. Ear aches in both ears from headache. Stomach upset for 4 days and couldn't eat. Body aches. Sleeplessness. Very light headed couldn't think for 4 days.
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| 62 | 2021-03-14 | difficulty swallowing |
AT TIME OF INJECTION - SENSATION UP ARM & NECK & LEFT SIDE OF HEAD. PT STATED FEELING SWELLING I...
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AT TIME OF INJECTION - SENSATION UP ARM & NECK & LEFT SIDE OF HEAD. PT STATED FEELING SWELLING IN MOUTH/THROAT - PT STATED HARDER TO SWALLOW
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| 62 | 2021-03-14 | nausea |
The day after the vax (Friday) All day my arm hurt so badly I could hardly raise it up. Around 7:30...
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The day after the vax (Friday) All day my arm hurt so badly I could hardly raise it up. Around 7:30pm, I got nauseous, a really bad headache and had really bad chills. I got two heating pads out, one for my arm and one to warm me up. It lasted ?til about 3am and then it was over. My arm is still a little tender, but otherwise I am back to "my normal".
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| 62 | 2021-03-15 | abdominal discomfort | Muscle & body aches, slight fever, chills, mild stomach upset, exhaustion |
| 62 | 2021-03-15 | nausea | Slight arm soreness initially. 12 hours later developed nausea, chills, body aches, temp of 100.5. |
| 62 | 2021-03-15 | vomiting | Pt vomited about 5 minutes after dose |
| 62 | 2021-03-16 | abdominal pain | Extreme liver pain, soreness under right rib cage from above waist to below breast |
| 62 | 2021-03-16 | GERD |
Myriad of symptoms first dose 12/16/21 runny nose, fatigue, sore throat, chills, and diarrhea -ne...
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Myriad of symptoms first dose 12/16/21 runny nose, fatigue, sore throat, chills, and diarrhea -negative Covid test day 8 Only one symptom second dose 1/5/21 only severe body aches Beginning March 3, 2021 onset of severe joint arthralgia in wrists, hands, elbows, shoulders, knees, and feet. This is along with fatigue and inability to walk or move without pain. This has exacerbated my carpal tunnel to becoming unbearable as well. This is totally NEW and NEVER had this before. If I had to describe the pain it is like inflammation similar to description of Rheumatoid Arthritis. NSAIDS are barely helpful and contraindicated as I have GERD with Barrett's esophagus. I have heard this reaction has been reported with post vaccination patients.
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| 62 | 2021-03-17 | diarrhea |
After my fourth day (March 16th) of the vaccine this is what happened: Day started great and about ...
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After my fourth day (March 16th) of the vaccine this is what happened: Day started great and about 1pm started having severe diarrhea with intervals of 15 to 30 minutes apart. At approximately 2:30pm I started having projectile vomiting. All of this lasted until approximately 5pm, I was also very clammy and cold, no fever. by 7pm I felt somewhat normal. The next day I felt great! It was an experience I've never had before so that why I am sending this to you!
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| 62 | 2021-03-18 | abdominal pain |
Sudden onset one hour after vaccine of severe irritable bowel. Became diaphoretic, bradycardic and ...
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Sudden onset one hour after vaccine of severe irritable bowel. Became diaphoretic, bradycardic and hypotensive and extreme abd pain. Was taken to the Emergency Room by coworker (I work in the hospital)
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| 62 | 2021-03-18 | appendicitis |
Appendicitis - patient contracted acute appendicitis approximately 20 hours after second does of Pfi...
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Appendicitis - patient contracted acute appendicitis approximately 20 hours after second does of Pfizer vaccine resulting in surgical removal.
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| 62 | 2021-03-18 | diarrhea | sore throat, dizziness, right eye pain, diarrhea, leg pain, fatigue, soreness at site area |
| 62 | 2021-03-18 | nausea | FEVER,NAUSEA,BODY ACHES AND JOINT PAIN |
| 62 | 2021-03-18 | vomiting, abdominal pain upper |
I had arm pain, aches, tired and vomited a few time. I felt weird all over. I had pain in my upper a...
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I had arm pain, aches, tired and vomited a few time. I felt weird all over. I had pain in my upper abdomen, legs and lower back. Chills and anxiety. On 2/8, I had a tele visit with my doctor. I took Tylenol as instructed to make sure that I didn't develop a fever. My doctor said that it could be from the vaccine. My left leg and foot were swollen on 2/13, so I called my doctor again and he sent me for a Doppler to check for a blood clot. I saw him on 2/15 in person. I have lower back pain and weakness in my legs at times, but it doesn't prevent me from doing anything. They feel heavy, especially if I walk for an extended period of time.
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| 62 | 2021-03-19 | nausea | tingling in legs, nausea, headache, pressure in chest, back pain |
| 62 | 2021-03-20 | diarrhea | Slight fever. Headache,tiredness,diarrhea,injection site pain. |
| 62 | 2021-03-20 | diarrhea |
Triggered Trigeminal Neuralgia symptoms. 5 minutes after injection left shoulder sore. 25 minutes af...
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Triggered Trigeminal Neuralgia symptoms. 5 minutes after injection left shoulder sore. 25 minutes after injection left side of lips became numb. Medics responded, as we were talking, realized numbness had followed the trigeminal nerve back to the ear, and then from the ear, toward the nose. we determined it was not life threatening, and I was asked to contact my healthcare provider. Left lower quandrant of cheek/face was swollen for between 24 - 36 hours. Developed diarrhea 24 hours after injection.
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| 62 | 2021-03-20 | vomiting, nausea |
woke 8am on 3/17 with dull headache . 12 noon headache became worse. Took Acetaminophen 500 mg 1p...
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woke 8am on 3/17 with dull headache . 12 noon headache became worse. Took Acetaminophen 500 mg 1pm broke out in cold sweat and became nauseated. 1:30 began vomiting. Remained nauseated, cold sweats off and on, multiple episodes of vomiting until 5pm
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| 62 | 2021-03-21 | nausea | Chills, nausea, aches, sore arm |
| 62 | 2021-03-22 | decreased appetite |
Patient developed fever (15 days after vaccination) that persisted for about 2 months, also develope...
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Patient developed fever (15 days after vaccination) that persisted for about 2 months, also developed cough, and anorexia as well as fatigue.
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| 62 | 2021-03-22 | decreased appetite |
Woke up with bad headache in back of head. Throat was hurting & swollen. Chills, achy muscles all o...
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Woke up with bad headache in back of head. Throat was hurting & swollen. Chills, achy muscles all over. Knee joint hurting bad. Not hungry. Slept a lot after taking Tylenol. Next day by 12:00 pm, I felt better.
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| 62 | 2021-03-22 | difficulty swallowing |
Headache at 5 pm, then severe difficulty swallowing and breathing and HBP started at 7:00 pm, went t...
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Headache at 5 pm, then severe difficulty swallowing and breathing and HBP started at 7:00 pm, went to ER, release at 2 am still having symptoms, not as severe. After 48 hours all symptoms gone.
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| 62 | 2021-03-22 | nausea |
Date and time adverse event started: pt was vaccinated on 3/11/21, she felt fatigued from 3/12-3/17,...
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Date and time adverse event started: pt was vaccinated on 3/11/21, she felt fatigued from 3/12-3/17, on later developed nausea and dizziness on 3/19 until today. recommended to call pmd in am for possible evaluation. symptoms could be from other medical conditions.
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| 62 | 2021-03-22 | nausea |
Intense enough Chest pain; jaw pain; back pain; nausea; This is a spontaneous report from a contacta...
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Intense enough Chest pain; jaw pain; back pain; nausea; This is a spontaneous report from a contactable consumer. A 62-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in left arm, on 18Feb2021 at 14:00 (Batch/Lot Number: EL9267) as SINGLE DOSE for covid-19 immunisation Medical history included hypertension and allergy to penicillin. Concomitant medication and pravastatin (PRAVASTATIN. On 19Feb2021 at 100am, the patient experienced chest pain and jaw pain where she seriously considered going to the ER. Also, the other common side effects of back pain and nausea. The outcome of the events was recovering. The patient was not hospitalized nor was treatment received.
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| 62 | 2021-03-23 | diarrhea |
Patient received first COVID-19 dose on Jan 14th, 2021 and then developed chest pain and diarrhea 1 ...
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Patient received first COVID-19 dose on Jan 14th, 2021 and then developed chest pain and diarrhea 1 day later. On Jan 17th, she presented to hospital and was found to have an non-ST elevated MI and apical ballooning syndrome.
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| 62 | 2021-03-23 | flatulence |
Occasional mild headache, occasional mild chills, a bit of gas, mild muscle aches, occasional hot fl...
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Occasional mild headache, occasional mild chills, a bit of gas, mild muscle aches, occasional hot flashes (more intense than usual) and occasional fatigue (usually starting around mid-afternoon) and lasting for three days, starting about 24 hours after second dose. No fever.
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| 62 | 2021-03-23 | nausea, decreased appetite |
I have a complex history of anaphylactic reactions to many allergens. Immediate reaction to Pfizer ...
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I have a complex history of anaphylactic reactions to many allergens. Immediate reaction to Pfizer vaccine #1--flushed/hot, strong metallic taste, chemical smell, tachycardia (156-158), nausea, some chest discomfort and dizziness. BP 158/85 (my normal is 100/60). O2 sats 98%. I did not feel anxious until heart rate would not come down to baseline. Clinic staff monitored me and did not treat. Allowed heart rate to decrease over time. Took over 20 minutes to get below 120. At 35 minutes, it was below 100. Stayed at clinic for one hour and released. Still had metallic taste (over 3 days now), loss taste, loss of appetite, headache, and fatigue.
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| 62 | 2021-03-23 | nausea | Chills, nausea, passed out, muscle aches |
| 62 | 2021-03-23 | vomiting, nausea |
Pt experienced nausea for 15 minutes after receiving vaccine with one episode of emesis. Pt reports ...
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Pt experienced nausea for 15 minutes after receiving vaccine with one episode of emesis. Pt reports nausea may be related to home medication which occasionally causes nausea for pt.
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| 62 | 2021-03-24 | abdominal discomfort |
Initially light headed and sever headache. The next day, developed severe skin burning sensation al...
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Initially light headed and sever headache. The next day, developed severe skin burning sensation all over body, including inside of mouth. This pain has increased as the days went on. This pain is severe, and continues into now 10 days. Dizziness and stomach upset has increased. Ringing in the ears and increased sensitivity to sound. Also experiencing weak and shakiness.
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| 62 | 2021-03-24 | decreased appetite |
Severe nausea for 5 days. Dizzy. Headaches. Severe pain all the way down my right arm to my finger t...
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Severe nausea for 5 days. Dizzy. Headaches. Severe pain all the way down my right arm to my finger tips, hand cramping off and on for 2 days. Not able to eat. Had to start taking Zofran on 4th day to be able to start slowly getting soft food in system.
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| 62 | 2021-03-24 | difficulty swallowing |
Client c/o swelling on site vaccine given, LD and some pressure when swallowing. Client reports hav...
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Client c/o swelling on site vaccine given, LD and some pressure when swallowing. Client reports having a headache on first COVID-19 dose. Site assessed and no swelling noted on LD, nor pain reported. No swelling observed near throat area. Upon client departure at 10:30 am, client was able to move arm and speak/swallow with no difficulties. Client advised to contact PCP if any other issues occur at home. Client verbalized understanding. Client assessed by EMT and nursing onsite. All vitals within normal limits.
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| 62 | 2021-03-24 | nausea |
Felt the vaccine immediately in arm, Got a funny taste in my mouth, Started feeling dizzy before I s...
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Felt the vaccine immediately in arm, Got a funny taste in my mouth, Started feeling dizzy before I stood up, Moved to a different chair from injection chair location. Passed out. Never vomited but become very nauseated. These symptoms all occurred within five minutes of the injection. Ran low grade fever all day on March 24 (day after).
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| 62 | 2021-03-25 | decreased appetite |
Severe chills/sweats, extreme fatigue, disrupted sleep, no appetite, shaky for 6 days but appear to ...
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Severe chills/sweats, extreme fatigue, disrupted sleep, no appetite, shaky for 6 days but appear to be lessening now
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| 62 | 2021-03-25 | nausea |
On 3/25 I had a sore arm with firmness around the injection site. Today I woke up very early with f...
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On 3/25 I had a sore arm with firmness around the injection site. Today I woke up very early with fever and chills and feeling pretty ill. Urinated and crawled into bed and put electric blanket on high until I felt warm. Got up about 7:00 and took my temperature and it was about 100. Then it varied between 99 and 102.5 all day. Had blurred vision and body aches and bad headache and nausea. .Took Tylenol or hydrocodone which helped with keeping temp closer to 100 but I?d fall asleep and forget to take Tylenol and it would go back to 102. I didn?t have anyone to drive me that I felt comfortable enough to risk exposure in case it was an actual illness and not the vaccine. I considered calling an ambulance but decided to wait and see if I could get my temp under control. This evening I?m at 100 again (I just took it again) but thought my fever had broken as I didn?t feel I was radiating heat like I felt when it was 102. My normal temp is usually around 97. I haven?t taken anything Tylenol or hydrocodone since about 3:00 but I will take just plain Tylenol now.
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| 62 | 2021-03-26 | decreased appetite |
Pain in neck, especially, has increased over the past couple of days. Very tired, aching, lethargic,...
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Pain in neck, especially, has increased over the past couple of days. Very tired, aching, lethargic, don't want to be bothered. Loss of appetite started today. Feel pressure in chest, but no cough to speak of.
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| 62 | 2021-03-26 | decreased appetite |
I developed Mononucleosis six weeks after my second dose of the Pfizer vaccine. Fever, severe night ...
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I developed Mononucleosis six weeks after my second dose of the Pfizer vaccine. Fever, severe night sweats, severe fatigue, loss of appetite, head aches, and blisters on my skin. I have not been exposed to Mononucleosis that I know of and have been isolated from the public because my husband had not been vaccinated yet. Mononucleosis has a 4-6 week incubation period which is when I took my second vaccine shot
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| 62 | 2021-03-26 | difficulty swallowing |
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tig...
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Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: carries APIS tablets which she uses if feels like have an anaphylactic episode. Waited an hour and left with no complications
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| 62 | 2021-03-26 | nausea |
Constant headache Body on fire Fatigue Nausea Dizziness Pain and muscle ache Anxiety High blood pr...
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Constant headache Body on fire Fatigue Nausea Dizziness Pain and muscle ache Anxiety High blood pressure
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| 62 | 2021-03-26 | vomiting |
Started w/slight dizziness next day that increased during day. At 3 am awaken from sleep w/extreme v...
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Started w/slight dizziness next day that increased during day. At 3 am awaken from sleep w/extreme vertigo/non- stopped vomiting for a few hours. Zofran from doctor stopped vomiting. Excessive sweating chills and hot flashes But no fever. Could not walk on own for 24 hours. Still experiencing dizziness if stand up or bend over too fast. Ringing in ears.
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| 62 | 2021-03-27 | decreased appetite, abdominal discomfort |
1st dose I had soreness in left arm and a stomach nausea the next day. 2nd dose I had at 2:00 p.m. ...
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1st dose I had soreness in left arm and a stomach nausea the next day. 2nd dose I had at 2:00 p.m. on 3/26/21. Woke up the next morning at 4:00 a.m. with pain in my arm and basically feeling terrible. I had pain in the arm, soreness under arm, achy and severe joint pain all over, headache over my eyes, extreme fatigue, chills on and off, a few instances of sweating, Generally felt really sick. Appetite decreased. The next night woke up in the middle of the night sweating, then later in the night with chills. Aching and pain in joints was miserable. By noon on 3/28/21 was feeling a lot better, still tired and arm just sore. Stomach still a little off.
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| 62 | 2021-03-27 | nausea |
pain at injection site. nausea, chills, headache, joint aches, general unwell feeling. This starte...
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pain at injection site. nausea, chills, headache, joint aches, general unwell feeling. This started during the afternoon after receiving injection in the morning-Friday. This continued all the next day-Saturday. All was resolved by the following morning-Sunday.
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| 62 | 2021-03-28 | nausea |
Patient received 2nd vaccine. About 10 mins after administration she reported nausea, light headed, ...
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Patient received 2nd vaccine. About 10 mins after administration she reported nausea, light headed, itching, rash, numbness. Patient requested to only have 25mg of Benadryl administered. Per Dr. ok to administer that amount. Benadryl 25mg IM in the left deltoid at 11:30 AM by RN
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| 62 | 2021-03-28 | nausea |
Head , neck sinus, Whole body flu like muscle pain lasting ten days. High fever on tenth day. Unbea...
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Head , neck sinus, Whole body flu like muscle pain lasting ten days. High fever on tenth day. Unbearable pain. Took covid test was negative. Daily nausea and farting all day.
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| 62 | 2021-03-29 | abdominal pain upper, nausea |
diarrhea w/ bright red blood; Severe stomach cramping; extreme nausea; back cramps; temp range 97.4 ...
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diarrhea w/ bright red blood; Severe stomach cramping; extreme nausea; back cramps; temp range 97.4 - 99.4; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 10Mar2021 09:30 (lot number: EN6204) as single dose for COVID-19 immunisation. The patient's medical history included high blood pressure, migraines, and thyroid disorder. The patient's concomitant medications included cyclobenzaprine, levothyroxine, telmisartan (TELMI), and topiramate (TROKENDI XR). The patient previously took erythromycin and morniflumate (FLOMAX) and experienced allergies to both. The patient experienced severe stomach cramping, diarrhea with bright red blood, extreme nausea, back cramps, temperature range 97.4 - 99.4, so sick and she had to lay on bathroom floor throughout night on 10Mar2021 20:00. There was no other vaccine in four weeks. The patient was not pregnant at the time of report. Prior to vaccination, patient has no COVID and patient was not tested for COVID post vaccination. The vaccination facility type was Health Department. The outcome of the events were recovering.
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| 62 | 2021-03-30 | decreased appetite, diarrhea, nausea |
After receiving the first shot, developed a headache on right side; later that evening had a runny n...
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After receiving the first shot, developed a headache on right side; later that evening had a runny nose; Nausea; Diarrhea; Loss of appetite; Sleep loss; Achy; Overall exhaustion; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EN6203, on 03Mar2021 11:00 at single dose in left arm for COVID-19 immunization. Medical history and concomitant medications were none. The patient had no Allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. After receiving the first shot, the patient developed a headache on right side on 03Mar2021 11:00, later that evening had a runny nose, nausea, diarrhea, loss of appetite, sleep loss, achy and overall exhaustion. This lasted for 7 days. Treatment received for headache and achy included Tylenol on day 3. The outcome of all events was resolving.
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| 62 | 2021-03-30 | difficulty swallowing |
difficulty swallowing; jaw got very sore like it started popping out of joint and couldn't open wide...
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difficulty swallowing; jaw got very sore like it started popping out of joint and couldn't open wide/large dime size knot on the left side of jaw right at tmj area; jaw got very sore like it started popping out of joint and couldn't open wide; tingling down left leg down to toes, left leg only/tingling on the left leg; large cyst on the left side of her jaw; sore right jaw with clicking sounds; large dime size knot on the left side of jaw, right at TMJ area;hardness; pimple; This is a spontaneous report from a contactable other health care professional. A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 (Batch/Lot Number: EN8203; Expiration Date: 30Jun2021) as SINGLE DOSE for covid-19 immunisation. There were no medical history and concomitant medications. On 04Mar2021, reports getting the vaccine on 04Mar2021 and has had a large cyst on the left side of her jaw, sore right jaw with clicking sounds and tingling on the left leg, an hour and a half after. Also reported difficulty swallowing. Reported that she had reactions, not immediately, but 1 hour and 15 minutes after the vaccine. Caller reports a large dime size knot on the left side of jaw, right at temporo mandibular joint (TMJ) area. Injection was on left side. Caller reported that minutes later, her jaw got very sore like it started popping out of joint, and couldn't open wide. She also states that she had tingling down the left leg, down to the toes, left leg only. States this all happen pretty much right at the same time, maybe 5-10 minutes of each thing happening. She is at home with grandson. She was on hold for a while already. Weird reactions, not the common ones. States that she is not going to take the second vaccine, is afraid to take it. At this point, it is just a hard knot (described as a large dime size knot), and he (the doctor) said to take a Benadryl, which she did. Knot, hardness resolved gone by 06Mar2021, but a pimple remained for 7 days. The outcome of the event jaw disorder, jaw pain, was recovered on an unspecified date, for the event tingling of extremity was recovered on 04Mar2021, for the event large dime size knot on the left side of jaw, right at TMJ area;hardness was recovered on 06Mar2021, while unknown for the other events. No follow-up attempts possible. No further information expected. Batch/lot number already provided; Sender's Comments: Considering the close temporal association (reportedly, the reactions occurred hour and 15 minutes after the vaccine), a causal association between the reported events and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 62 | 2021-03-31 | abdominal pain |
Patient presented on 3/29/21 with abdominal pain and was found to have acute pancreatitis not due to...
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Patient presented on 3/29/21 with abdominal pain and was found to have acute pancreatitis not due to alcohol, gallstones, or hypertriglyceridemia. Patient was treated with supportive care and discharged from the hospital on 3/3/1/21.
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| 62 | 2021-04-01 | appendicitis |
acute appendicitis; This is a spontaneous report from a non-contactable consumer (patient herself). ...
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acute appendicitis; This is a spontaneous report from a non-contactable consumer (patient herself). A 62-year-old female patient, not pregnant, received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, administered in the right arm, on 15Mar2021 16:00, at a single dose, for covid-19 immunization. The patient has no medical history. There were no concomitant medications. The patient previously took codeine and experienced allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), on 22Feb2021 in the right arm for covid-19 immunization at the age of 62-years-old. The vaccine was received at the hospital. The patient did not receive other vaccines within four weeks. The patient has no Covid prior vaccination. The patient incurred acute appendicitis on 16Mar2021 12:30 PM, 20 hours after second dose. There were no indications of difficulty prior. This resulted in surgical removal of appendix. The adverse event resulted in emergency room/department or urgent care visit and, hospitalization for 2 days (from Mar2021 to Mar2021). The patient was recovering from the adverse event at the time of the report. The patient had a Covid-test via nasal swab on 18Mar2021 with results of negative. No follow-up attempts are possible; information about the lot/batch number cannot be obtained.
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| 62 | 2021-04-09 | nausea, diarrhea, decreased appetite |
fever; feeling out of body experience; diarrhea; in tears from intensity of the sensation; visual pi...
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fever; feeling out of body experience; diarrhea; in tears from intensity of the sensation; visual pictures that were kind of ridiculous and seeing things; Severe headaches; Heard a lot of noises in head; body hurting severely where she couldn't walk; body hurting severely where she couldn't walk; no appetite; nauseas; This is a spontaneous report from a contactable healthcare professional (patient). A 62-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6205) via an unspecified route of administration, administered in Arm Left, at the age of 62-year-old, on 18Mar2021, as SINGLE DOSE for covid-19 immunisation. Medical history included covid-19 from Oct2020. The patient's concomitant medications were not reported. The patient previously received flu shot as immunization and did not get any reactions and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN6205) on 28Feb2021, single dose for covid-19 immunisation and experienced very achy, some fever, some diarrhea, one episode and a big headache, difficulty Sleeping, and intense sensations. The patient experienced severe side effects/ bad reactions three weeks after receiving the second dose of vaccine. The patient experienced visual pictures that were kind of ridiculous and seeing things (medically significant) on 19Mar2021 with outcome of recovered on 21Mar2021, severe headaches (non-serious) on 19Mar2021 with outcome of recovered on 21Mar2021, heard a lot of noises in head (non-serious) on 19Mar2021 with outcome of recovered on 21Mar2021, body hurting severely where she couldn't walk (non-serious) on 18Mar2021 with outcome of recovered on 21Mar2021, fever (non-serious) on an unspecified date with outcome of recovered on 21Mar2021, diarrhea (non-serious) on 19Mar2021 with outcome of recovered on 21Mar2021, in tears from intensity of the sensation second half of the day after receiving Pfizer Covid Vaccine (non-serious) on 19Mar2021 with outcome of recovered on 21Mar2021, no appetite (non-serious) on 18Mar2021 with outcome of unknown, nauseas (non-serious) on 18Mar2021 with outcome of unknown, feeling out of body experience (non-serious) on an unspecified date with outcome of unknown. The diarrhea was reported as much more intense. The patient doesn't know how else to describe it, except it was very intense and severe. No appetite and nauseas which lasted 2-3 days, it's almost like feeling out of body experience. The events did not require a visit to Emergency room or Physician office. The patient did not receive vaccination within 4 weeks prior vaccination. No relevant tests performed.; Sender's Comments: Based on the close temporal relationship, the association between the event "seeing thingis" with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 62 | 2021-04-10 | decreased appetite, nausea |
2 days after i received the vaccine had difficulty breathing shortness of breath and on 5 and 6 days...
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2 days after i received the vaccine had difficulty breathing shortness of breath and on 5 and 6 days also then had chills hand tremors loss of appetite nausea this continued for 2 more months. I went to Urgent care and on March 26 then found a clot in my right lung. I am on warfin now and none of these symptoms did I have prior to the vaccine. I had 5 covid tests to see if I had COVID but all the tests were negative.
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| 62 | 2021-04-15 | GERD |
fluid like blister on roof of mouth, red dots on skin, extreme fatigue and worsening of arthritis sy...
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fluid like blister on roof of mouth, red dots on skin, extreme fatigue and worsening of arthritis symptoms and GERD
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| 62 | 2021-04-15 | vomiting |
Extreme dizziness and vomiting occurred 4/10/21. Diplopia and numbness began on 4/11/21 and continue...
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Extreme dizziness and vomiting occurred 4/10/21. Diplopia and numbness began on 4/11/21 and continued. MRI and CT scans confirmed that the patient experienced a transient ischemic attack (TIA) and Veretebral artery dissection (HCC) between 4/10 and 4/11.
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| 62 | 2021-04-16 | decreased appetite |
* On 4/2/21 - Fever 103.2, Fatigue, No appetite, Dizziness. * On 4/5/21 - Severe chest pain. Went t...
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* On 4/2/21 - Fever 103.2, Fatigue, No appetite, Dizziness. * On 4/5/21 - Severe chest pain. Went to ER. Transferred to clinic in. Admitted to clinic on 4/5/21: - Test: Ultrasound, Xray, Lab Tests, Electrocardiogram - Outcome: Pericardial enhancement adjacent to the left ventricle with no effusion - Treatment: Motrin 400 mg/4 times a day, Protonix 40mg/day to protect stomach
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| 62 | 2021-04-17 | diarrhea, abdominal pain upper, indigestion |
I received the shot through my employer, at a High School. I experienced stomach pain 4 hours after...
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I received the shot through my employer, at a High School. I experienced stomach pain 4 hours after shot. Initially I thought it was upset stomach from dinner, but everyone else was fine and my condition worsed. My intestines felt inflamed. I had intermittent diarrhea. 6 days later I went to Urgent Care as it was clear to me that there was something wrong.
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| 62 | 2021-04-17 | nausea |
After initial two days of side effects of temp and fatigue, nausea, continued side effects of extrem...
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After initial two days of side effects of temp and fatigue, nausea, continued side effects of extreme fatigue, nausea low grade temp for ten days, fatigue got worse; resulting in extreme shortness of breath. i went to the emergency room where i was diagnosed with AFIB. I spent 6 days in hospital. No previous condition of AFIB. An exam and physical in July did not reveal any health issues.
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| 62 | 2021-04-17 | nausea |
eyes rolled back/passed out; my throat area under my jaw line started to hurt; my left leg was achy ...
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eyes rolled back/passed out; my throat area under my jaw line started to hurt; my left leg was achy and tingly; my left leg was achy and tingly; headache; nauseated; weak; fever; just didn't feel good; sick; became rigid; This is a spontaneous report received from a contactable consumer (patient). A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer-BioNTech, lot unknown=true, lot unknown reason=unable to locate or read the details) via an unspecified route of administration in right arm on 26Mar2021 11:45 (62-year-old at vaccination date) at a single dose for COVID-19 immunization. Medical history included hypertrophic cardiomyopathy (HCM), a bruit, ventricularomegaly, gastrointestinal (GI) issues, many female issues (before she got a hysterectomy), cancer activity, hepatitis C (Hep C), COVID-19 since 18Mar2021 (diagnosed as extremely positive, remained sick until 25Mar2021), and allergies to medications, food, or other products included Motion sickness meds. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination was reported as yes but unspecified. About 25 minutes after the vaccine, her throat area under her jaw line started to hurt, her left leg was achy and tingly, and she was started to get a bad headache. She became nauseated and weak. She made it home, took paracetamol (TYLENOL), and got in bed. Saturday her headache was on steroids, she had fever, and just didn't feel good. Later that day, she was so sick she went to the bathroom and she guessed she passed out. Basically, her husband said he found her on the floor after he heard a thump. He asked me what was his name. He said she responded correctly, but then her eyes rolled back, she became rigid, and he called 911. she knew 2 sets of paramedics arrived w/ambulances. They monitored her vitals and stayed until she was normal. They were willing to take her to the hospital, but offered other options for her husband and she to consider. They suggested she see her Primary care doctor (she did on 29Mar2021). Her doctor believed she should not take the 2nd dose of the vaccine. Adverse event start date was 26Mar2021 at 12:30 pm. AE resulted in doctor or other healthcare professional office/clinic visit. It was reported no treatment received for the adverse event. The outcome of event was resolving. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 62 | 2021-04-18 | abdominal distension, decreased appetite |
Adverse reaction: Sudden severe shortness of breath when I exerted myself, severe constant headache ...
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Adverse reaction: Sudden severe shortness of breath when I exerted myself, severe constant headache that tylenol couldn't dull, fatigue and weakness, weak shoulders could keep them raised for more than a few seconds, swelling of abdomen, rapid fluid retention, lack of appetite, chest felt constricted, nose bleeds, black sticky stools Treatment: 2 units of blood, ferrouse sulfate IV, saline IV, protonix IV, endoscopy Outcome:health back to normal, after blood transfusion, will continue to take pantoprazole for six weeks and Iron Note: used to have ulcers years ago due to H. Pylori bacterium suspect Pfizer mRNA vaccine interacted with H. Pylori antibodies as has been found in other patients with H. Pylori.
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| 62 | 2021-04-19 | diarrhea |
Information obtained from the Hospital. Began to not feel well the next day, SOB, diarrhea and fatig...
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Information obtained from the Hospital. Began to not feel well the next day, SOB, diarrhea and fatigue. Was admitted to hospital on 4/9/21, diagnosed with COVID, placed on a vent and died on 4/19/21.
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| 62 | 2021-04-24 | diarrhea |
She was shaking, she thought she was having a seizure with how bad she was shaking; She was shaking,...
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She was shaking, she thought she was having a seizure with how bad she was shaking; She was shaking, she thought she was having a seizure with how bad she was shaking; Chills; Fever; sore hands and wrists; sore hands and wrists; totally exhausted; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 01Apr2021 15:00 (Lot Number: EPT533) as single dose for covid-19 immunisation. The patient previously took flu shot. Medical history included diabeticc, thyroid is done, real bad psoriasis, high blood pressure, triglycerides, cholesterol , anxiety, to replenish potassium. Concomitant medications included metoprolol taken for hypertension; acetylsalicylic acid (ASPIRIN (E.C.)); citalopram taken for anxiety; amlodipine taken for blood pressure; hydrochlorothiazide; fenofibrate taken for blood triglycerides; atorvastatin taken for blood cholesterol; losartan potassium to replenish potassium; colecalciferol (VITAMIN D3); metformin taken for diabetes mellitus; levothyroxine; hydroxyzine; guselkumab (TREMFYA) taken for psoriasis,. The patient was shaking, she thought she was having a seizure with how bad she was shaking, chills, fever, sore hands and wrists, totally exhausted, diarrhea on 01Apr2021. The outcome of events chills, Wrist pain, Pain in hand was recovered on 05Apr2021; The outcome of event Fever and Diarrhea was recovered on 06Apr2021; outcome of other events was recovering.
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| 62 | 2021-04-24 | vomiting, nausea, retching |
cold and hot; gum were bleeding after second dose; felt like she was going to die after second dose;...
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cold and hot; gum were bleeding after second dose; felt like she was going to die after second dose; cold sores on lips after second dose; threw up after second dose; soreness after second dose; dizzy and weak after second dose; dizzy and weak after second dose; chills after second dose; sweating after second dose; dry heaving after second dose; nauseated after second dose; dehydrated after second dose; hasn't eaten for 5 days after second dose; This is a spontaneous report from a contactable consumer (patient, self-reported). A 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FR8737and expiry date was not provided), via an unspecified route of administration, in left arm, on 07Apr2021, as a single dose (at the age of 62-years) for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, solution for injection, lot number: EN6201 and expiry date was unknown), via an unspecified route of administration, in left upper arm, on 05Mar2021, as a single dose for COVID-19 immunization. The patient arm hurt after first dose (began immediately and lasted for about 4 days) which was resolved on 09Mar2021. Patient second dose was scheduled on 27Mar2021, but she did not get it till 07Apr2021. It was reported that on 08Apr2021, patient had such an awful reaction to the second dose of the vaccine. She started to get dizzy and weak, chills, everything was a blur, sweating, could not drink threw up if she tried dry heave went back to sleep and slept for 48 hours had just chills the whole time. She was in bed sleeping trying to drink, getting up to go to the bathroom and feeling like she was going to die for the next three days. She was nauseated and is still nauseated and could not drive. She took Tylenol an antiemetic at urgent care that stopped. She took Zofran with the saline solution infusion and she went home and slept. She was dehydrated and had soreness all over. On 09Apr2021, she could not roll over and had a sore on her left butt cheek that was still there cold sores on lips. She thought the sore on her left butt cheek came from laying in bed so much, and it was not in any other space but that one spot almost like she would have gotten the shot there, but she didn't. On 10Apr2021, patient felt like she was going to die, and went to urgent care and asked if they could give her fluids. They gave her fluids and Zofran and that helped a lot. This one shocked the hell out her, she thinks it was her gums that started to bleed on 11Apr2021. She had the best oral hygiene and went to the dentist all the time. She was flosses like crazy. She started to drink a ton of water and has not seen it since. She cannot guess what the reason was. On 11Apr2021, she could function a little and had chills again last night and sweating. She did not have a fever. She ate chicken noodle soup water and a little bit of ginger ale. She started to feel better, but not 100% better not even 90%, not even 80%, but was heading towards the right direction. Patient also hasn't eaten for 5 days after second dose. She experienced cold and hot. She was not complaining at all and she has been sick for days and cannot eat and will throw up but will gain it right back. The dizziness and weakness were subsided. She feels like she is getting beat up but is recovering. Patient thought that vaccine pulled out with a syringe and that's the problem everyone gets the same dose. Patient's weight was 136 or 138 lbs. Outcome of the events nauseated after second dose was resolved on 10Apr2021, and dizzy and weak after second dose was resolved on an unknown date in Apr 2021, and for the events chills and sweating it was recovering, and for all other events, it was unknown.
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| 62 | 2021-04-27 | diarrhea |
Doppler showed a blood clot; Pain behind her cast; Really bad case of diarrhea; Swelling in her knee...
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Doppler showed a blood clot; Pain behind her cast; Really bad case of diarrhea; Swelling in her knee; Leg was swelling/right shoe was tight; Lower extremity venous ultrasound right calf vein acute deep vein thrombosis of the right lower extremity involving the popliteal vein; It was tender on her right leg on the left side of the tibia/It is very tender to the touch; Red mark on her leg with a little nodule; Red mark on her leg with a little nodule; Calf pain; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EP7533; Expiration date was not reported) on the right arm on 30Mar2021 as a single dose, with route of administration unspecified, for COVID-19 immunization at the clinic. Medical history included pain and headache. Concomitant medications included paracetamol (TYLENOL ARTHRITIS) for pain; hydrocodone for pain; amitriptyline for headache; and ongoing paracetamol (TYLENOL EXTRA-STRENGTH) for pain. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6208; Expiration date was not reported) on the right arm on 11Mar2021 (when the patient was 62 years old) for COVID-19 immunization. On 07Apr2021, the patient's doppler showed a blood clot. On 30Mar2021, the patient had a really bad case of diarrhea; swelling in her knee; and leg was swelling/right shoe was tight. On 02Apr2021, the patient had pain behind her cast. On an unspecified date in 2021, the patient's lower extremity venous ultrasound showed right calf vein acute deep vein thrombosis of the right lower extremity involving the popliteal vein; was tender on the right leg on the left side of the tibia that was very tender to the touch; had a red mark on her leg with a little nodule; and had calf pain. The events had resulted into an emergency room visit and physician's office visit. The patient had received treatment for the events, 'blood clot', 'lower extremity venous ultrasound right calf vein acute deep vein thrombosis of the right lower extremity involving the popliteal vein', 'leg was swelling/right shoe was tight', 'pain behind her cast' and 'tender on her right leg on the left side of the tibia that was very tender to the touch'. The outcome of the events was recovered on 30Mar2021 for 'really bad case of diarrhea'; was recovering for 'leg was swelling/right shoe was tight', 'pain behind her cast' and 'red mark on her leg with a little nodule'; and was unknown for all the other events.
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| 62 | 2021-04-27 | nausea |
My partner felt pain overnight. Then, felt flu like symptoms- plus chills- the next day and night. T...
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My partner felt pain overnight. Then, felt flu like symptoms- plus chills- the next day and night. The following morning at 7:00 am, Patient said that she felt real sick. She also, complained of having a real bad Headache, Not long after that, she felt like throwing up. She tried to throw up. Except, nothing came out and she felt very nauseous because of the vaccine. When she came call to bed, I offered to make her some breakfast to help her feel better. Unfortunately, she felt, too, I'll to try and eat an food because of the way she felt. So, I laid next to her with the hope that all would be well. Because, the pharmacist who administered the second dose. Assured my partner, that it was normal to feel flu like symptoms the next day. So, we never doubted what the pharmacist advised. All of sudden, she suffered a cardiac arrest in my presence and died in front of me.
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| 62 | 2021-04-28 | retching |
went in and out of consciousness, RN reported dry heaving and throat tightness. was sent to the hosp...
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went in and out of consciousness, RN reported dry heaving and throat tightness. was sent to the hospital ED for further evaluation
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| 62 | 2021-04-30 | diarrhea |
felt low blood pressure; weak; confused; When fell hit self on head, lip, nose, and eye; When fell h...
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felt low blood pressure; weak; confused; When fell hit self on head, lip, nose, and eye; When fell hit self on head; bruises on face; had burst lip; diarrhea; leg pain; fainted; seizure; felt hot; chills/shaking.; This is a spontaneous report from a contactable consumer (patient herself). This 62-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unspecified route of administration in the left arm, on 13Apr2021 at 21:00 (at the age of 62-year-old) as single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EP6775 MS 389) administered via an unknown route in the left arm on 17Mar2021 (at 10:00 AM) for COVID-19 immunisation. No other vaccine was received in four weeks. Relevant medical history included gastritis and anxiety. Past drug history included allergy to mirtazapine (REMERON). Relevant concomitant medications included diazepam (VALIUM), vitamins and probiotics. On 13Apr2021 at 23:00 the patient had chills / shaking. On 14Apr2021 at 02:00 AM, she felt hot. She went to bathroom, felt low blood pressure, weak, and fainted. Woke up, felt disoriented, not know where she was, confused. When fell hit self on head, lip, nose, and eye. She suffered various bruises on face. May have had seizure, had burst lip and felt was biting. Then suffered diarrhea that day. She also experienced leg pain. She went to the doctor on 16Apr2021. On unknown date, blood work up was done and results were not provided. The patient was recovering from the events. Information on the lot/batch number has been requested.
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| 62 | 2021-04-30 | vomiting |
blood pressure (BP) was usually 110/70 however 8 hours after shot BP was 145/85; really bad vertigo ...
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blood pressure (BP) was usually 110/70 however 8 hours after shot BP was 145/85; really bad vertigo and dizziness; really bad vertigo and dizziness; facial palsy; vision in her right eye got fuzzy; face got numb on the right side; hot electrical nerve zinging entire right arm, right shoulder blade and right calf; sore arm; feel sick; hangover; vomiting; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 62-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the right arm on 16Apr2021 11:15 (Batch/Lot Number: EW0162) as single dose (at the age of 62-years-old) for COVID-19 immunisation. Medical history included anaphylaxis: carries an epi pen, and has allergies to wasps. The patient also took unspecified dietary supplements. The patient had no other vaccine in four weeks. The patient got her first vaccine dose on 16Apr2021 and reported having a history of anaphylaxis and carried an epi pen. She stayed at the vaccination facility for an hour and a half and she got facial palsy and her vision in her right eye got fuzzy. Then her face got numb on the right side. It took 4 hours for it to go away but by dinner she felt ok. She added that immediately after the shot (16Apr2021), she experienced hot electrical nerve zinging entire right arm, right shoulder blade and right calf that lasted 30 minutes; blurry vision right eye started 15 minutes after shot, recurred off and on for 6 hours; facial palsy on right side that started about 30 minutes after shot that lasted 4 1/2 hours; vertigo/dizziness that started 7 hours after the shot; and blood pressure (BP) was usually 110/70 however 8 hours after shot BP was 145/85. She filed a report online when her symptoms began to subside. A couple hours later, she began to feel sick again and went to bed. When she walked to her mailbox, she was feeling ok but when she bent over to get the mail, that made it all worse. She woke up feeling as if she had a hangover and reported vomiting right away after getting out of bed. She had really bad vertigo and dizziness. She also had a sore arm (unspecified which arm) and stated that she was "experiencing everything on the freaking list." The patient wanted to know if this was normal and asked if she should get the second dose. She was advised that if she had a severe allergic reaction after a previous dose of the vaccine, she should not get the Pfizer-BioNTech Covid-19 vaccine. She also wanted to know if her symptoms got worse over the weekend and wanted to know what were the signs if she should go to the hospital. The patient did not receive any treatment for the adverse effects. The patient did not have COVID prior to vaccination and was not COVID tested post vaccination. The patient recovered from hot electrical nerve zinging entire right arm, right shoulder blade and right calf 16Apr2021 11:45; face got numb on the right side on 16Apr2021 15:15 and facial palsy on 16Apr2021 16:15. The outcome of the remaining events was unknown.
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| 62 | 2021-05-04 | abdominal discomfort |
Left jaw is swollen so huge and it's just hard and now it's going into my lip; Lower lip is numb and...
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Left jaw is swollen so huge and it's just hard and now it's going into my lip; Lower lip is numb and it's going down into my throat and up in my ear and it's very painful; I am in severe pain; Lower lip is numb and it's going down into my throat and up in my ear and it's very painful; I am in severe pain; Lower lip is numb and it's going down into my throat and up in my ear and it's very painful; I am in severe pain; Lower lip is numb and it's going down into my throat and up in my ear and it's very painful; I am in severe pain; short of breath/I can't breath; am still not well, Bad condition here; am still not well, Bad condition here; dizziness; tired; deltoid starts swelling; lost feeling in my mouth; Left jaw is swollen so huge and it's just hard and now it's going into my lip; my stomach was upset; my jaw was sore; The initial case was missing the following minimum criteria: ICH-unspecified product. Upon receipt of follow-up information on 22Mar2021, this case now contains all required information to be considered valid. A 62-year-old female consumer (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EL3302) via an unspecified route of administration on 11Mar2021 in left arm at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. As per the context, it was reported that consumer stated, I took the vaccine (Unspecified Vaccine) the first dose on Thursday and right now my left side, they gave it into my left arm and my left jaw is swollen so huge and it's just hard and just like really hard and now it's going into my lip, my lower lip is numb and it's going down into my throat and up in my ear and it's very painful; she was in severe pain. Consumer stated, I took the vaccine 11Mar2021 and next day i.e. on 12Mar2021 I get up and my jaw was sore and then my stomach was upset and then as the day started on my jaw started swelling really big. I took it on 11Mar2021 and I am still not well, Bad condition here, I have lost feeling in my mouth and I can't breath either. It was the first vaccine and this is the very last I am not taking again. Consumer stated, I had a trip to the emergency room. Regarding lab data, consumer stated, No, they documented how swollen was my jaw was, I didn't know I was short of breath until I start back exercising and then I can't breath in there. Consumer stated, Well I just wanted to know how long this is going to last then because I have lost feeling in my mouth. Consumer stated, I got a vaccine back in March and I called Pfizer then because I had, my deltoid starts swelling and I had to go to the emergency room because that's what the paper says if you have facial swelling. So now my deltoid is still swelling, it will go down some and it will start swelling again, I have got numbness in my lips and my chin, dizziness and it hurts. So, I just wanted to know what you can do for that and along with that if it's normal. Consumer stated, Well I have been on hold for an hour, just to get this number, can't you just type the information in have them contact me. When tried to probe for further questions, Consumer stated, I have already documented and I just need to talk to somebody that know what to do to get my job back, like it was. Consumer stated, I went to the emergency room, the paper that they gave it to me vaccine was (name withheld), it's a drive through and they vaccinated it was the first vaccine I got, and I did not go back and get another one because I haven't recovered from that one yet. My face is out swelling up, my lips numb, my cheeks numb and numb. I am just tired and dizzy. The outcome for the events swelling face, lip swelling, hypoaesthesia oral, pharyngeal hypoaesthesia, hypoaesthesia, pain, general physical health deterioration, malaise, abdominal discomfort, pain in jaw,sensory loss, swelling, dizziness and fatigue were not reported and for the event deltoid starts swelling it was reported as not recovered/not resolved. Information about batch/lot number had been requested.
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| 62 | 2021-05-06 | nausea, abdominal pain upper, vomiting |
vomiting; chest pain; stomach pain; nausea; chills; body ache; stomach pain more intense; acute panc...
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vomiting; chest pain; stomach pain; nausea; chills; body ache; stomach pain more intense; acute pancreatitis; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot ER2613, second dose) solution for injection intramuscular in the left arm on 23Mar2021 at 09:00 (at the age of 62-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included ARMD (age-related macular degeneration), high blood pressure, and anxiety. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN) and AREDS vitamins. The patient had no known allergies. Historical vaccine included BNT162B2 (first dose, lot EN6202) for COVID-19 vaccination on 02Mar2021 with no adverse effect reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 24Mar2021 at 07:00, the patient experienced stomach pain, nausea, chills, and body ache. On 26Mar2021, the patient experienced vomiting and chest pain. In Mar2021, the patient experienced acute pancreatitis and stomach pain more intense. The events resulted in emergency room/department or urgent care visit and hospitalization for 10 days in 2021. Lab test in Mar2021 included CT scan: revealed acute pancreatitis. Treatment for the events included antibiotics, fluids, and oxygen. The outcome of the events was recovered in 2021. Since the vaccination, the patient has not been tested for COVID-19.
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| 62 | 2021-05-07 | vomiting, nausea, diarrhea |
Dizzy; Weak; Non-stop vomiting for 8 hours; Nausea; Loose stools; Body Aches; Chills, no fever; Too ...
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Dizzy; Weak; Non-stop vomiting for 8 hours; Nausea; Loose stools; Body Aches; Chills, no fever; Too sick to call Pfizer yesterday about symptoms; Has a ton of mucous discharge; This is a spontaneous report from a contactable Nurse. A 62-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: JR8729), via an unspecified route of administration, administered in Deltoid Left on 21Apr2021 as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 62 years). The patient's medical history was not reported. There were no concomitant medications. The patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: EN6207) on 31Mar2021 for covid-19 immunisation and experienced Sore Arm after first vaccine (Age at vaccination: 62 years). The patient also had a historical vaccine of Flu vaccine on 16Oct2020 for immunisation and experienced Local Reaction; Redness at injection site (Age at vaccination: 61 years). The patient experienced non-stop vomiting for 8 hours on 22Apr2021 02:30, nausea, loose stools, body aches, chills, no fever and too sick to call Pfizer yesterday about symptoms on 22Apr2021, dizzy and weak on 23Apr2021. The patient also stated that she has a ton of mucous discharge on Apr2021. The events were considered as medically significant by the reporter. Outcome of the event vomiting was recovered on 22Apr2021, outcome of the events body aches and chills was recovering while outcome of the events mucous discharge and sickness was unknown. Outcome of the remaining events was not recovered.; Sender's Comments: There is a reasonable possibility that the events vomiting, nausea, diarrhea, and chills were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the other reported events with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 62 | 2021-05-10 | appendicitis | Acute appendicitis approximately 10 days post vaccination. Partially ruptured, surgery required. |
| 63 | 2021-01-04 | abdominal pain |
6-7 hours after the vaccine she developed arm pain, fever and chills. About an hour later she start...
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6-7 hours after the vaccine she developed arm pain, fever and chills. About an hour later she started to have abdominal pain which worsened over the course of the day to excruciating. She went to the Emergency Room where a CT scan revealed a perforation of her sigmoid colon and had a resection of the area of the colon and a diverting colostomy surgery done the evening of 1/3/2021.
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| 63 | 2021-01-05 | nausea | Temperature 101, headache, ears hurt, body aches , nauseated |
| 63 | 2021-01-06 | diarrhea | I had a positive Covid 11/11/20. My main symptom was loose stools x 3 weeks |
| 63 | 2021-01-06 | indigestion, abdominal pain |
This is a self report: two days after the vaccine I developed severe heart burn ( something I have ...
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This is a self report: two days after the vaccine I developed severe heart burn ( something I have never experienced). Several over the counter medication were used without relief. . The heart burn was followed by a horrible gastric disturbance. I experienced abdominal pain, cramping and rectal pain. During this time my temperature remand between 100.0 - 101.0 with fatigue and malaise. I have also noticed several welts on my body. I?m typically a very health person and have never experienced any of these experiences before.
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| 63 | 2021-01-06 | nausea, vomiting | Headache, NauseaVomiting, Sore throat,fatigue Narrative: |
| 63 | 2021-01-07 | nausea | EVENING OF 12/30/20, DEVELOPED BODY ACHES AND NAUSEA THAT LASTED APPROXIMATELY 12 HOURS. |
| 63 | 2021-01-07 | vomiting, nausea |
Headache, Myalgia, Arthralgia & NauseaVomiting Narrative: Is taking Ibuprofen/ Advil, also took Zof...
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Headache, Myalgia, Arthralgia & NauseaVomiting Narrative: Is taking Ibuprofen/ Advil, also took Zofran for nausea. Body aches are 10/10, sometimes improve down to 8/10.
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| 63 | 2021-01-09 | nausea |
At 13:10 the patient complained of sudden nausea while walking from injection room to seating area a...
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At 13:10 the patient complained of sudden nausea while walking from injection room to seating area at vaccine clinic. States she did not eat lunch today, declined offer of snack or water. States she premedicated herself with 25 mg Benadryl 30 minutes before today's vaccine - as she does for all vaccines she gets.
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| 63 | 2021-01-09 | nausea |
Hard, pounding tachycardia, with dizziness, nausea, headache, occurred about 5 minutes after vaccine...
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Hard, pounding tachycardia, with dizziness, nausea, headache, occurred about 5 minutes after vaccine was administered. The tachycardia resolved without medical intervention within 2 minutes. The remainder of the symptoms remained the rest of the day, along with profound fatigue and intermittent self limited tachycardia. The headache was managed with Tylenol. I slept most of the day and through the night. The following day, I had a headache, which was mild. Fatigue remained. I also noted intermittent tachycardia with mild exertion, self limited, less than 1 minute. Mild soreness at injection site.
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| 63 | 2021-01-11 | diarrhea, nausea, vomiting | Nausea vomiting and diarrhea |
| 63 | 2021-01-11 | nausea |
Tachycardia, shortness of breath, and nausea with second dose of Pfizer-BioNTech COVID-19 vaccine 0....
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Tachycardia, shortness of breath, and nausea with second dose of Pfizer-BioNTech COVID-19 vaccine 0.3 mL IM in left deltoid. vitals stable. Monitored in clinic for 1 hour and then sent to ED for further evaluation. ECG normal. Patient able to discharge in stable condition.
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| 63 | 2021-01-12 | nausea, decreased appetite |
horrible body aches; Nausea; head fogginess; felt like a lump and couldn't move; not wanting to eat;...
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horrible body aches; Nausea; head fogginess; felt like a lump and couldn't move; not wanting to eat; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received BNT162B2 (Batch/lot number: E10140) first dose on 28Dec2020 11:15AM in the right arm at single dose since she is front line health care worker. Medical history included pain. Medical history included tramadol for pain. No Prior Vaccinations (within 4 weeks). Family Medical History Relevant to AE was none. She received the vaccine 28Dec2020 and it flattened her for two days. Her primary care provided has advised her not to take the next dose. Within 45 minutes she noticed nausea. She was eating lunch and she felt like everything was coming up and she forced herself not to vomit. The she noticed horrible body aches; head was foggy; she felt like a lump and couldn't move;. The body aches hurt in her arms, legs, hips, and back. Adds she was out of work for two days. She could feel it working as the symptoms would peak and then drop. She did go back to work but shouldn't have as she continued to feel nauseous and not wanting to eat. All of these symptoms have now resolved. Vaccination Facility Type was nursing home. No Vaccine Administered at Military Facility. Facility Name: Nursing Home. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Event not resulted in Physician office or ER. The outcome of the event nausea was recovered on 02Jan2021. The outcome of event not wanting to eat recovered on 03Jan2021. The outcome of other events was recovered on 01Jan2021. The seriousness criteria for event horrible body aches was reported as medical significant.; Sender's Comments: The patient had medical history included pain. A possible contribution role of the first dose of BNT162B2 to the horrible body aches cannot be excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 63 | 2021-01-12 | nausea, diarrhea | Chills, malaise, dizziness, diarrhea, nausea |
| 63 | 2021-01-12 | nausea | Baseline tinnitus got much louder, headaches, intermittent nausea, sore throat |
| 63 | 2021-01-12 | nausea |
instant severe nausea lasting until mid morning on 1/8 1 hr later swelling of the eye lids and lips ...
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instant severe nausea lasting until mid morning on 1/8 1 hr later swelling of the eye lids and lips 25mg Benadryl taken before the shot and after the onset of the swelling of eyes and lips
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| 63 | 2021-01-12 | vomiting |
Starting on 1/8 she began having headaches and weakness in her legs. On 1/9 the headache got worse, ...
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Starting on 1/8 she began having headaches and weakness in her legs. On 1/9 the headache got worse, she had a COVID test which was negative. On 1/11 she had vomiting for hours after taking Tylenol. On 1/13 she still has a headache, but also SOB and body aches
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| 63 | 2021-01-13 | abdominal pain |
Severe diffuse abdominal pain awakened from sleep at night; Severe diffuse abdominal pain awakened f...
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Severe diffuse abdominal pain awakened from sleep at night; Severe diffuse abdominal pain awakened from sleep at night; This is a spontaneous report from a contactable nurse (patient). A 63-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration in the left arm on 06Jan2021 14:00 at a single dose for COVID-19 immunization at the hospital. Medical history included high blood pressure and allergies to penicillin. Concomitant medication included losartan. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe diffuse abdominal pain awakened from sleep at night on 07Jan2021 01:00 AM. The patient took Tylenol. The events lasted 2 hours from 1am-3am. Outcome of events was recovered on 07Jan2021 03:00 AM. The events were assessed as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
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| 63 | 2021-01-13 | diarrhea |
chills; fever up to 102; diarrhea; This is a spontaneous report from a contactable other healthcare ...
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chills; fever up to 102; diarrhea; This is a spontaneous report from a contactable other healthcare professional (HCP, patient herself). A 63-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: ek5730, expiration date: unknown), intramuscularly on the right arm on 18Dec2020 at 16:15 at a single dose for COVID-19 immunization administered at the hospital. The patient's medical history and concomitant medications were not reported. The patient previously took codeine, for which she had known allergies. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Dec2020 at 19:00, the patient experienced chills, fever up to 102, and diarrhea. The reporter assessed the events as non-serious. Therapeutic measures were taken as a result of chills, fever up to 102, and diarrhea as she talked to her family physician. The patient recovered from all the events on an unspecified date.
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| 63 | 2021-01-13 | nausea, diarrhea |
Chills; headache; nausea; diarrhea; muscle and joint pain; muscle and joint pain; strange coffee tas...
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Chills; headache; nausea; diarrhea; muscle and joint pain; muscle and joint pain; strange coffee taste; This is a spontaneous report from a contactable Nurse (patient). A 63-year old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch unknown) via an unspecified route of administration on 05Jan2021 14:30 on right arm at a single dose for COVID-19 immunization. The patient known allergy included Penicillin allergy and other medical history included Diabetes 2, Hypertension, Reynauds and obesity. There is no other vaccine in the four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications in two weeks included losaeten, metformin, hydrochlorthiazide, duloxetine hydrochloride (CYMBALTA). The patient took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Dec2020 14:30 on left arm at a single dose for COVID-19 immunization. The patient experienced chills, headache, nausea, diarrhea, muscle and joint pain, strange coffee taste on 06Jan2021 02:00 and result in doctor or other healthcare professional office/clinic visit. No treatment received for these adverse events. The patient did covid test post vaccination via Nasal Swab on 07Jan2021 and result negative. The outcome of the events was not recovered. Information on lot/batch number has been requested.
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| 63 | 2021-01-14 | nausea | Fever, chills, headache, body aches, nausea, generalized weakness |
| 63 | 2021-01-16 | nausea | Low grade fever, chills, body aches, headache, nausea |
| 63 | 2021-01-16 | vomiting |
2.5 hours after receiving vaccine, I started getting dizzy and vomiting. I vomited 6 or 7 times. I w...
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2.5 hours after receiving vaccine, I started getting dizzy and vomiting. I vomited 6 or 7 times. I was so dizzy I couldn't open my eyes without getting sick. We called ER and explained that we thought I was having a reaction to the vaccine, and their response was they had never heard of that type of reaction. I was sick all night, called my primary Dr in the am and they told me to go to ER. We had to call ambulance to take me there because I was so sick and couldn't open my eyes without having to vomit. Room spun in circles. My arrival at ER, they did MRI, EKG, blood work. My blood pressure was very high, so they connected me to a heart monitor. I had low Magnesium due to vomiting so much. I was treated with Valium and anti-vert medication and fluids. I stayed overnight in hospital- had PT Jan 13th for DX of Vertigo. Then referred to Outpatient PT for Vertigo. Dr's felt it was a "coincident" that I got Vertigo shortly after vaccine, and strongly felt it was not related. . Today is Jan 17th, and I am still dizzy, but feeling better. I have an appointment with my primary Jan 18th and not sure if I should take the 2nd dose. That is the question.
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| 63 | 2021-01-17 | nausea |
1/6 THROUGH 1/10: SEVERE HEADACHE, NAUSEA, CHILLS (OVERWHELMING), JOINT PAIN, FEVER (100), MUSCLE AC...
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1/6 THROUGH 1/10: SEVERE HEADACHE, NAUSEA, CHILLS (OVERWHELMING), JOINT PAIN, FEVER (100), MUSCLE ACHES. TOOK TYLENOL.
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| 63 | 2021-01-18 | nausea, abdominal pain |
10:00am - Vaccine given. 10:15am - client reported experiencing nausea & headache (pain scale: 8/10)...
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10:00am - Vaccine given. 10:15am - client reported experiencing nausea & headache (pain scale: 8/10). BP - 172/85mmHg; Pulse - 94). 10:18am - BP - 176/93mmHg; Pulse - 104 10:20am - BP - 186/93mmHg; Pulse - 105, client reports the pain and nausea symptoms are the same. Client taken to an exam room and placed lying down on her left side, head slightly elevated. Client reported feeling a bit cold, covered with disposable gowns for warmth. Temperature taken at 10:34am - Temperature: 37 degrees Celsius. 10:43am - BP 130/60mmHg, Pulse - 92. Client reported that feelings of nausea is gone, however is still experiencing slight headache 4/10 pain scale. 10:57am - BP 124/64mmHg; Pulse - 88 10:59am - BP 174/89mmHg; Pulse - 99. Client reports that she feels a sharp pain on her abdominal area by the belly button (6/10). Also reports a mid-back pain (9/10 pain scale). 11:10am - BP 162/86mmHg; Pulse - 101 11:15am - BP 147/78mmHg; Pulse - 89. Client reports abdominal pain at 5/10, mid-back pain 8/10. 11:25am - BP 155/82mmHg; Pulse - 90. Client reports abdominal pain is aching at 5/10 pain scale, mid-back pain 7/10 pain scale.
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| 63 | 2021-01-18 | nausea |
from 1201 am to 0515 am on 1/7/21--headache, neck pain, cold hands/feet, chills, nausea, low grade f...
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from 1201 am to 0515 am on 1/7/21--headache, neck pain, cold hands/feet, chills, nausea, low grade fever (99 degrees) treatment taken at 0515 am --1 dramamine, 2 tylenol 0800 am- headache, temp 98.3 0915 am- headache treatment- 1 advil pm 0815 pm- temp 99, chills treatment- tylenol 3 days post vaccine- headache, nausea (treatment advil pm, dramamine) 6 days post vaccine- headache, nausea (treatment advil pm, dramamine) 9 days post vaccine--headache, nausea (treatment advil pm, dramamine)
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| 63 | 2021-01-18 | nausea | Systemic: Nausea-Medium, Systemic: Flushing-Medium |
| 63 | 2021-01-19 | diarrhea | Diarrhea |
| 63 | 2021-01-19 | nausea |
12 hrs after vaccine headache,nausea,achy,sore arm 24 hrs after vaccine fever 100.2, bad chills,hea...
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12 hrs after vaccine headache,nausea,achy,sore arm 24 hrs after vaccine fever 100.2, bad chills,headache,body aches,very sore arm 36 hrs after vaccine swollen lymph nodes under rt arm, temp 99.8
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| 63 | 2021-01-20 | nausea |
itching across shoulders /back of neck; nausea; body aches; chills; She felt like there was a tight ...
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itching across shoulders /back of neck; nausea; body aches; chills; She felt like there was a tight band around chest.; sense the she couldn't get a good breath; pulse of 101-129; she had tinnitus, and she noticed that both injections made that worse; This is a spontaneous report from a contactable nurse. A 63-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK4176/expiration date) dose number 2 intramuscularly on 08Jan2021 11:45 at a single dose on the left arm for COVID-19 immunization. The patient received the vaccine in a hospital. Medical history included severe allergic reaction to pecans and tinnitus. Historical vaccine included BNT162B2 on 18Dec2020 (dose number 1, intramuscularly on the left arm) for COVID-19 immunization. The patient experienced tinnitus, sinus infection, and stuffy head after the first dose. No other vaccines were administered within 4 weeks and no other medications were taken within 2 weeks. The patient was not diagnosed with COVID prior vaccination and was not tested for COVID post-vaccination. On 08Jan2021, after the 2nd dose, the patient experienced itching across shoulders/back of neck and sl nausea. She took Benadryl which relieved the itching. She went to bed and had onset of body aches, chills, and sense the she couldn't get a good breath. She felt like there was a tight band around chest. Her O2 Sat was 95% - 98%, with pulse of 101-129, T max was 101.8. The symptoms were lasting about 6 hours. In the morning, the patient took Aleve and Benadryl. Most symptoms were alleviated. She took those meds scheduled for 48 hrs. She noticed that if she tried to push past scheduled time, the itching started to return, so she just kept the meds scheduled for 48 hours. No other symptoms after that. She added that she had tinnitus, and she noticed that both injections made that worse. It was not yet subsiding since last injection. The patient also received Tylenol for the events. The outcome of the events was recovered in Jan2021.
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| 63 | 2021-01-20 | vomiting, nausea | Fever, chills, body aches, nausea/vomiting |
| 63 | 2021-01-21 | diarrhea | Chills, diarrhea. Improved. |
| 63 | 2021-01-21 | nausea, diarrhea, abdominal discomfort |
Diarrhea, nausea, abdominal discomfort, injection sight was very sore. Anti- diarrhea over the coun...
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Diarrhea, nausea, abdominal discomfort, injection sight was very sore. Anti- diarrhea over the count medication taken. Bed rest for 2 days.
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| 63 | 2021-01-21 | nausea, vomiting, decreased appetite |
As I was sitting at my computer and suddenly I could barely keep my eyes open, I was so tired I coul...
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As I was sitting at my computer and suddenly I could barely keep my eyes open, I was so tired I couldn't lift my arms and once I closed my eyes, I could not muster the strength to open them. I felt like I was going to faint and then I got nauseated and I knew I was going to throw up. With my husband's help, I did manage to get to the bathroom (about 6 steps away). I threw up and immediately sat down in the nearest chair. I threw up a second time into a vessel after that. I then got a massive headache and chills. I could barely walk with assistance up the stairs to go to bed. I have never been more fatigued. After going to bed, I slept all night and woke the next day still fatigued, but nothing like the night before. I was able to work, even though I felt really tired. I did not have much of an appetite all day and two days later, I still feel fatigued.
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| 63 | 2021-01-21 | nausea |
Body aches, very sore injection site, tired feeling, nausea, slight headache. I had the chills, cou...
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Body aches, very sore injection site, tired feeling, nausea, slight headache. I had the chills, couldn?t get warm. Got worse during the night. Couldn?t go to work the next day due to body aches, arm soreness, extreme tiredness. Slept almost all day 1-19-21. Spiked low grade fever during the night. Worked 1-20-21, but extremely sleepy. Injection site got hot and red. Slept 12 hours that night. Went to work 1-21-21 feeling good, just still a little arm soreness.
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| 63 | 2021-01-21 | nausea | Fever, body aches, chills, nausea |
| 63 | 2021-01-21 | nausea | Nausea, headache, body aches |
| 63 | 2021-01-21 | vomiting | pt. experiencing arm pain, vomiting, shortness of breath, dizziness |
| 63 | 2021-01-22 | nausea |
Evening of both doses I had nausea which went away overnight, (also had very strange dreams with fre...
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Evening of both doses I had nausea which went away overnight, (also had very strange dreams with frequent waking up which might have had nothing to do with the vaccine). Second dose nausea the first night, extreme fatigue the second day which was gone by day 3. Headache from day after vaccine until today (5 days later) with more severe headache and dizziness today, but not bad enough to make me not be able to function.
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| 63 | 2021-01-22 | vomiting |
Chills for 3 hours and than abnormal gait which got so bad that became unable to walk for 10 hours w...
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Chills for 3 hours and than abnormal gait which got so bad that became unable to walk for 10 hours without falling down. At first had to hang on to things to walk and than unable to stand or sit up- felt like I was being pushed backwards. Emesis all day
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| 63 | 2021-01-23 | nausea |
I am submitting this report because I did not download the app until day three post vaccination. The...
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I am submitting this report because I did not download the app until day three post vaccination. The app would not allow me to report my vaccine reaction retroactively to include the previous days. Twelve hours post vaccination: slight chills without fever, severe headache, nausea and fatigue Twenty four hours post vaccination: severe headache, moderate nausea and fatigue Forty eight hours post vaccination: moderate headache, mild nausea and fatigue Seventy two hours post vaccination: symptoms resolved (*Correction: I believe I may have recorded the date for vaccine #1 incorrectly on the form I previously submitted regarding a reaction to my second vaccination. When asked if I had received any previous vaccinations within the past 4 weeks, the correct date for my first Covid-19 vaccination should read 12/28/2020, 10:00 am)
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| 63 | 2021-01-24 | gastrointestinal pain, nausea |
Injection site pain, tiredness, headache , muscle pain, chill, joint pain, nausea, feeling unwell, s...
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Injection site pain, tiredness, headache , muscle pain, chill, joint pain, nausea, feeling unwell, swollen lymph nodes, difficulty breathing, swelling of face, fast hearbeat, bad rash , dizziness and weakness, intestinal pain. All symptoms lasted 18 days. Was given prescription medication for symptoms by primary care doctor.
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| 63 | 2021-01-24 | nausea |
Nausea 2 days, headache 3 days, aches 5 days, fever one day (100.2), sniffles with clear drainage, r...
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Nausea 2 days, headache 3 days, aches 5 days, fever one day (100.2), sniffles with clear drainage, rash over right eye across inter canthus to lower lid, redness inner right eye, and slight rash right nose.
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| 63 | 2021-01-25 | abdominal discomfort |
Soreness at injection site for 72 hours.; Low grade fever 99.6 orally on day 3.; GI upset for 3 days...
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Soreness at injection site for 72 hours.; Low grade fever 99.6 orally on day 3.; GI upset for 3 days; Migraine headache on day 6.; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) via an unspecified route of administration in the right arm, on 30Dec2020 at 11:00 A.M., at a single dose, for COVID-19 immunization. Relevant medical history included high blood pressure (BP), seasonal allergies, migraine, asthma, right sided hearing loss. The patient was taking unspecified concomitant medications. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 01Jan2021, at 8:00 A.M., the patient experienced soreness at injection site for 72 hours. On day 3, the patient had low grade fever 99.6. On an unspecified date in Jan2021, the patient had gastrointestinal (GI) upset for 3 days. On day 6, the patient experienced migraine headache. The patient did not receive therapy for the events. Outcome of the events was recovered. The patient has not been tested for COVID-19 since vaccination.
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| 63 | 2021-01-25 | abdominal pain, diarrhea |
Diarrhea and abdominal cramping 1 hour after second dose of Covid vaccine. Took OTC medication, Imod...
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Diarrhea and abdominal cramping 1 hour after second dose of Covid vaccine. Took OTC medication, Imodium, motrin, soft bland diet. Six + episodes of diarrhea in one hour on 1/21/2021 with significant cramping. Went to ER. Received fluids and IV Zofran. CBC and CMP WNL. Stool test also done--negative. Discharged. Severe diarrhea morning of 1/22/2021. Missed work on 1/21 and 1/22. Diarrhea and abdominal cramping continued intermittently. Worked Monday. Stool samples provided. C.Diff negative. Lactoferrin positive. Enteric bacterial panel negative. CT of abdomen scheduled for 1/27/2021
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| 63 | 2021-01-25 | gastrointestinal disorder | GI issues , fever to 99.6, achy everywhere, chills |
| 63 | 2021-01-25 | nausea |
Arm pain at site; Fatigue; Nausea; Body aches; This is a spontaneous report from a contactable nurse...
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Arm pain at site; Fatigue; Nausea; Body aches; This is a spontaneous report from a contactable nurse reported for herself. This 63-year-old no pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Et1685) intramuscular on 11Jan2021 13:15 at single dose for an COVID-19 immunization. Medical history included high blood pressure. Concomitant medication included atenolol Atenolol, Losartan, Calcium, plantago ovata (METAMUCIL), bifidobacterium lactis (PROBIOTIC). Patient received the first dose of BNT162B2 intramuscular in left arm on 21Dec2020 03:30 PM. No other vaccine in four weeks. On 12Jan2021, the patient experienced Arm pain at site, Fatigue, Nausea, Body aches. No treatment received. The outcome of events was not recovered.
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| 63 | 2021-01-25 | nausea | headache, body ache, chills, fatigue, sore arm, Nausea |
| 63 | 2021-01-25 | nausea | Sore arm, dizziness, nausea , lightheaded |
| 63 | 2021-01-25 | nausea |
I noted onset of chronic, mild nausea 15Jan21 to present. Eating or drinking usually quells it. Bi...
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I noted onset of chronic, mild nausea 15Jan21 to present. Eating or drinking usually quells it. Bilateral ramped up to the point & noted that I am talk louder than usual and am asking 'What did you say?' frequently with hearing aids. Having to discriminate against tinnitus causes mental fatigue. Marked increase and violence of head tremor (as noted with influenza vaccine) making sleep difficult where head will not stop shaking.
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| 63 | 2021-01-26 | abdominal discomfort | Sudden onset of chills and shakes for about 6 hours, headache, stomach distress, muscle aches, |
| 63 | 2021-01-26 | diarrhea, abdominal discomfort, indigestion, burping, nausea |
About 5:30 or so and I was going to go to lunch at work - I felt like a heartburn and I was looking ...
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About 5:30 or so and I was going to go to lunch at work - I felt like a heartburn and I was looking for a tums. I didn't have any. I asked a coworker because my chest felt like I had heartburn. It was really bad. Protonic - a coworker gave it to me to see if that would help. And I took it. Diaphoretic - sweating - coworker noticed that I was sweating. I had pain in my jaw. I thought I was showing signs of a heart attack. A doctor came over and we told her what was happening with me. He recommended that I should be seen right away. Next thing I know, nurse is wheeling me down to ER in wheelchair as my chest pains weren't going away but ER told me I had to go through triage and wait. Finally got seen and I had an EKG - which was good. CDU unit - was admitted to and checked Troponin levels and did blood work. Everything came back fine. My EKG was being monitored all night. At one point I was feeling something and they gave me a dose of Nitro. It gave me a headache. There all night and then I did a stress test in the morning. And I was released that day. That was my day off so I was off all work. I went back to the work the day after. My granddaughter came to stay with me over Christmas and she started having symptoms of COVID. She wasn't feeling well. /She tested positive.Symptoms for COVID began for me on December 26th and was tested for COVID on December 27th - cough; sore throat; headache, fever, not got chills or lose my taste or smell (until after those symptoms were finished); belching - lots; diarrhea; upset; nausea. Extremely tired and muscles aches, joint pain - settled in my lower back and my hip. I still struggle with those joint pain and tiredness today. They put me off work until January 12 2021. I was scheduled to get the dose 2 at 9th but didn't get it that day because of COVID illness.
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| 63 | 2021-01-26 | nausea, diarrhea |
Woke up on 1/26/21 with aches which lasted until 1/27/21. After I got up I had loose bowel movements...
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Woke up on 1/26/21 with aches which lasted until 1/27/21. After I got up I had loose bowel movements approx. 15-20 mins apart for approx 2 hours. Felt nausea upon waking and for 2-3 hours. Became dizzy about 1 1/2 hour to 2 hours after waking. Duration of dizziness approx 1 hours. Tired all day. 1/27/21 woke up with all symptoms gone. New symptom was swollen lymph gland under right arm and very sore. Duration 3 hours so far. Will call primary doctor.
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| 63 | 2021-01-26 | nausea |
: 01.25.21, 1st day of vaccination Both sides of neck, lots of pain along with hard time turning...
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: 01.25.21, 1st day of vaccination Both sides of neck, lots of pain along with hard time turning neck with stiffness . 2nd day Chills, headache. Joints are in pain along with other body pain, nausea. Now, fever 99.1. 3rd day is today, 01.27.21, voice is affected, fatigued body is very achy.
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| 63 | 2021-01-27 | diarrhea | sick with a fever, body aches, congestion, diarrhea |
| 63 | 2021-01-27 | nausea, vomiting |
fever, nausea, vomiting, severe body aches severe left arm pain, all symptoms worse that 1st dose. F...
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fever, nausea, vomiting, severe body aches severe left arm pain, all symptoms worse that 1st dose. Fever persisted from 1/7/21 to 1/10/21. Seen in ER 1/9/21 with T 101.9 again & workup (-) for bacterial infection /sepsis , COVID neg, flu neg.
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| 63 | 2021-01-27 | nausea |
Vertigo for 2 hours- stayed low to the ground so I wouldn't fall. It's been 3 days since my vaccinat...
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Vertigo for 2 hours- stayed low to the ground so I wouldn't fall. It's been 3 days since my vaccination and I still feel slight vertigo once in awhile Blurred vision for 2 hours Nausia for 2 hours
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| 63 | 2021-01-28 | difficulty swallowing, decreased appetite, abdominal pain |
dysuria, abdominal, pelvic, left flank, upper and lower back pain. bladder spasms, urinary frequency...
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dysuria, abdominal, pelvic, left flank, upper and lower back pain. bladder spasms, urinary frequency, headache, vision changes, loss of appetite, dysphagia and fatigue
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| 63 | 2021-01-28 | nausea |
Severe chills, painful glands especially under L arm, fever (low grade, never over 100.5), muscle ac...
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Severe chills, painful glands especially under L arm, fever (low grade, never over 100.5), muscle aches and weakness, joint pain, severe head ache, nausea, extreme fatigue and slight confusion. Started about 11 hourse post injection and symptoms lasted 20 hours. Acetaminophen and increased water intake. Intermittent bedrest. Missed a day of work. Then suddenly everything cleared and I was wide awake and clear headed, just a little weak in muscles.
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| 63 | 2021-01-30 | nausea | mild headache, chills, nausea, muscle and body aches |
| 63 | 2021-01-31 | nausea |
2:30 AM 1/30/21 chills, skin sensitive to touch, fever, extreme headaches, dizziness, nausea, redne...
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2:30 AM 1/30/21 chills, skin sensitive to touch, fever, extreme headaches, dizziness, nausea, redness at site of injection
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| 63 | 2021-02-01 | nausea | Nausea and HA one hour after Pfizer vaccine. Fatigue and aches 6 hours to 36 hours. |
| 63 | 2021-02-01 | nausea | Moderate muscle aches, fatigue, headache and nausea |
| 63 | 2021-02-01 | nausea |
Scattered dizziness and nausea; Scattered dizziness and nausea; This is a spontaneous report from a ...
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Scattered dizziness and nausea; Scattered dizziness and nausea; This is a spontaneous report from a contactable nurse, the patient. A non-pregnant 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK4176), via an unspecified route of administration in the right arm, on 13Jan2021 at 07:00 AM (at the age of 63-year-old) as a single dose for COVID-19 immunization. Medical history included high cholesterol, regurgitation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included sertraline hydrochloride (ZOLOFT), rosuvastatin calcium (CRESTOR), omeprazole (PRILOSEC). The patient previously took erythromycin and experienced drug hypersensitivity. The patient has allergy to penicillin. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EH9899), right arm on 23Dec2020 for COVID-19 immunization. On 15Jan2021, the patient experienced scattered dizziness and nausea. The patient did not receive any treatment for the events. The clinical outcome of the scattered dizziness and nausea was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 63 | 2021-02-03 | indigestion, burping, nausea, vomiting |
feeling nauseous; vomiting; indigestion; belching; This is a spontaneous report from a Pfizer-sponso...
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feeling nauseous; vomiting; indigestion; belching; This is a spontaneous report from a Pfizer-sponsored Program, from a contactable consumer. A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry date: Mar2021), intramuscular on 15Jan2021 on left arm at a single dose for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications. The patient got her first shot for the vaccine last Friday afternoon (15Jan2021). Yesterday early evening (19Jan2021), she was feeling nauseous and was vomiting. She wanted to know if it was an adverse effect from the COVID-19 vaccine even though it was the 4th day after getting the COVID-19 vaccine. She also mentioned that she ate a bunch of pistachios and wasn't sure if that was a contributing factor to what she was experiencing. The patient experienced indigestion, belching, and vomiting on 19Jan2021. She is feeling okay now and asked if that was normal. She confirmed contact details. She was asking if it was normal to have the side effects 4 days after getting the vaccine. She is so much better and has not vomited since 07:30 this morning. She has improved within the last hour. She still has tightness in her upper intestines, but it could be because she is hungry since she has not had anything since yesterday. She is glad she is feeling better. Stated the indigestion could be from all the pistachios that she ate at work. She took tums. She still had indigestion and ate a small dinner. She kept vomiting after, and it was more of a liquid. She put her glasses on. She has a hard time seeing the lot number on the card she was provided, stating it is so small Dose reported as 30mcg or 0.3ml. The outcome of the events was recovering.
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| 63 | 2021-02-03 | nausea |
delirious dreams; extreme chills; so cold that it felt like burning ice cubes on skin, could not get...
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delirious dreams; extreme chills; so cold that it felt like burning ice cubes on skin, could not get warm even with multiple blankets; severe body aches; severe headache; fever of 101; nausea; thirsty; Symptoms began to abate today (almost 48 hours later) but still fet some foggy thinking; This is a spontaneous report from a contactable other health care professional (patient) and a contactable consumer. A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELIZ83), via an unspecified route of administration at arm left on 19Jan2021 at single dose for COVID-19 immunization. The patient medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously received fist dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at arm left on 29Dec2020 at 9:30 at single dose for COVID-19 immunization. On Jan2021, the patient reported that 15 hours after second dose, he experienced extreme chills, so cold that it felt like burning ice cubes on his skin, he couldn't get warm even with multiple blankets, severe body aches, fever of 101 F, severe headache, delirious dreams, nausea, thirsty and feel some foggy thinking. The patient outcome of the event was recovering.
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| 63 | 2021-02-03 | nausea |
1st day nausea, next day rapid heart rate, sore arm, headache, nausea 3rd day - sore arm, headache,...
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1st day nausea, next day rapid heart rate, sore arm, headache, nausea 3rd day - sore arm, headache,nausea,chills 4th day - headache, chills and feeling hot, nausea,skin rash , itching, tired,aches 5th day - headache,chills and feeling hot, nausea,rash and uncontrollable itching, tired.
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| 63 | 2021-02-03 | vomiting |
8:20 pm - Patient received Pfizer COVID-19 dose 2 vaccine at 3:41 pm. Came in to c/o severe headache...
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8:20 pm - Patient received Pfizer COVID-19 dose 2 vaccine at 3:41 pm. Came in to c/o severe headache, dizzy, vomiting, and chills. BP high initial 176/81 P: 76, 97.7, O2: 99%. Patient has hx of HTN ans took medicine in the am. IMT called 8:25 pm, assessed vitals retaken (BP: 189/84; P:82 right arm; BP: 188/86, P: 82 left arm, and transported via wheelchair to Emergency Center for evaluation.
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| 63 | 2021-02-04 | abdominal pain lower, decreased appetite |
Lower Abdominal pain started Sunday evening, Comes and goes with anorexia for 7 days. Seen by prov...
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Lower Abdominal pain started Sunday evening, Comes and goes with anorexia for 7 days. Seen by provider on 1/22.
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| 63 | 2021-02-05 | abdominal pain lower, diarrhea |
its been 7 days now and am just getting sicker from then shot itching has increased and now have hem...
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its been 7 days now and am just getting sicker from then shot itching has increased and now have hematomas on my body. lungs fill heavy and headaches gotten more painful and i fell like my brain is not right. and diarrhea with pain in lower abdomen . I do not think i should be getting the second shot. I do not have a doctor and cant afford to go to er. I send you information of the first 5 days but do not have that report number.
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| 63 | 2021-02-08 | nausea, vomiting |
Severe head pain started at about 4 am on 1/29 and progressively got worse. By 7 am it led to nausea...
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Severe head pain started at about 4 am on 1/29 and progressively got worse. By 7 am it led to nausea, vomiting, and incapacitating pain. I would rate this a 10 out of 10 on pain scale. My Dr. was contacted and I was prescribed Zofran for nausea and Imitrex for the migraine about 11 am. The medications eased the symptoms to a manageable level. I have no current history of migraines, and have had two subsequent migraines, but not as severe.
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| 63 | 2021-02-09 | difficulty swallowing |
Patient is a 63 y/o female with itchiness to her back of her throat, tongue tingling and having trou...
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Patient is a 63 y/o female with itchiness to her back of her throat, tongue tingling and having trouble swallowing.
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| 63 | 2021-02-09 | nausea |
left ear ringing; bad headache; nauseous; no energy; I don't feel well; This is a spontaneous report...
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left ear ringing; bad headache; nauseous; no energy; I don't feel well; This is a spontaneous report from a contactable other healthcare professional (patient). A 63-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: Elo142), via an unspecified route of administration into the left arm on 14Jan2021 14:30 at a single dose for covid-19 immunisation. Medical history was reported as none. Patient was not pregnant. Concomitant medication included calcium (CALCIUM), vitamin d3 (VITAMIN D3) and monascus purpureus (RED YEAST RICE). On 14Jan2021, patient experienced bad headache, was nauseous, had no energy and was not feeling well. On 15Jan2021, patient also experienced left ear ringing. The patient received no treatment for the events reported. Outcome of events was recovering.
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| 63 | 2021-02-10 | nausea |
my lips were tingling followed by naushia , high blood pressure and heart rate. the ambulance was c...
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my lips were tingling followed by naushia , high blood pressure and heart rate. the ambulance was called i was then transported to hospital. where i had two sezuires. i was given adavan and sent home. with the instructions i was not allowed to have a follow up shot
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| 63 | 2021-02-11 | nausea |
Pfizer BioNTech COVID-19 Vaccine EUA left armpit lymph node swelling injection site pain headache na...
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Pfizer BioNTech COVID-19 Vaccine EUA left armpit lymph node swelling injection site pain headache nausea joint pain
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| 63 | 2021-02-15 | nausea |
Within in an hour of receiving the vaccine, under the injection about 2-3 inches below the site, the...
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Within in an hour of receiving the vaccine, under the injection about 2-3 inches below the site, the muscle group was sore. The next morning I was dizzy, lightheaded, mild headache, nausea, chills. It went all throughout the day. I just drank some clear liquids and ate some soup. When I woke up the next day about 36 hours after receiving the vaccine I had low energy, nauseous, and lightheaded . By that night my arm started feeling weird, it had a tinging feeling, I went to look at it the mirror and there was a red area and bumps but it was lower under the injection site. It seemed to get worse, swelling and more rash so I took Loratadine 10 MG (antihistamine). I went to bed and when I woke up this morning the rash was gone but the soreness is still there and the tinging feeling in my arm is still there. It feels like when your arm falls asleep. I tried to called my doctor but their phones are down and I will try reach back out this afternoon.
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| 63 | 2021-02-16 | nausea |
Patient became nauseated and felt a swelling sensation in her throat approximately 15 minutes after ...
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Patient became nauseated and felt a swelling sensation in her throat approximately 15 minutes after receiving her second dose of vaccine. She was treated with 25mg of benedryl and 10mg of cetirizine.
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| 63 | 2021-02-17 | abdominal pain |
I had a shingles vaccine on November 30, 2020. On Dec 30, 2020 I had my first dose of Covid vaccine...
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I had a shingles vaccine on November 30, 2020. On Dec 30, 2020 I had my first dose of Covid vaccine. On Jan 6, 2021 I went to the ER for severe abdominal pain, 2 days later broke out with rash and diagnosed with Shingles. I took steroid, Valtrex and Gabapentin. Rash on abd and around to lower back, left side. The rash was not bad but the nerve pain was horrible. 2nd dose was due Jan 22, 2021, I was advised to wait due to still having shingle pain. I was getting better, pain was subsiding so I got my 2nd dose on Feb 5, 2021. I experienced an increase in my shingle pain, from a 2 up to a 5, for about another week. It is still some pain, I am still on Gabapentin and Tylenol to keep the pain at about a constant 1-2 (Feb 18, 2021).
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| 63 | 2021-02-17 | difficulty swallowing, decreased appetite, diarrhea, abdominal pain |
tongue was swollen and swore feeling in the back of mouth/tongue sensation continued with swollen fe...
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tongue was swollen and swore feeling in the back of mouth/tongue sensation continued with swollen feeling; tongue was swollen and sore feeling in the back of mouth/tongue sensation continued with swollen feeling; difficulty swallowing; sore throat sensation; no appetite; severe abdominal pains; diarrhea; mild heart palpitations; developed fever of 101 Fahrenheit; chills; back pain; Could not Sleep; This is a spontaneous report from a non-contactable consumer reported for herself. A 63-year-old female patient (not pregnant at the time of vaccination) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3247, via an unspecified route of administration on 22Jan2021 09:00 at single dose in left arm for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was in hospital. Medical history included Hashimoto Disease; Moderate Metro Valve Prolapse; known allergies: food Intolerances (Gluten, Eggs, Diary, Soy, Corn). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ciclosporin (RESTASIS), calcium carbonate, colecalciferol (CALCIUM WITH VITAMIN D), ascorbic acid (VITAMIN C), ubidecarenone (COQ-10). The patient previously received the first dose of bnt162b2 with lot number: L0140 on 30Dec2020 10:30 AM in left arm for covid-19 immunisation, ciprofloxacin (CIPRO) and experienced drug allergy. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Jan2021 (Friday Evening) post injection, she could not sleep. On 23Jan2021 (Saturday) severe abdominal pains post breakfast; breakfast was gluten free bread with vegan scrambled eggs and coffee w/ oat milk. Continued diarrhea for about 1 hour; mild heart palpitations, developed fever of 101 Fahrenheit; mild chills and back pain. On 24Jan2021 (Sunday) - still with fever 99.8; no appetite. On 25Jan2021 (Monday) - tongue was swollen and sore feeling in the back of mouth; difficulty swallowing; sore throat sensation; pain of swelling caused it hard anything; remained home from work, did not see medical doctor. From 25Jan2021 to 28Jan2021 tongue sensation continued with swollen feeling, each day getting slightly better by 28Jan2021 (Thursday) feeling normal. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was recovered in Jan2021. The reporter considered the case as non-serious. No follow-up attempts are possible. No further information is expected.
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| 63 | 2021-02-17 | nausea |
This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient rec...
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This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in the left arm on 02Feb2021 01:00 at single dose for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a workplace clinic. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included benazepril, atorvastatin calcium (LIPITOR), and ubidecarenone (COQ 10). On 02Feb2021 01:15, after 5 minutes getting the vaccine on her left arm, it started to get numb and her back and left leg. She had a headache and nausea. The nurse at the clinic took her to a room to rest and applied ice pack on her left arm. She stayed in the room for 2 hours. At night, her heart rate was rapid and she could not sleep. Next day, she had muscles sore and headache. Therapeutic measure was taken as a result of numbness in the left arm,. No treatment was received for the other events. Clinical outcome of the events was recovered with sequelae. Information on the lot/batch number has been requested.
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| 63 | 2021-02-18 | abdominal pain lower |
Within 1.5 hours of vaccine #1: Eye pain (both), itching without visible rash (left buttock only), ...
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Within 1.5 hours of vaccine #1: Eye pain (both), itching without visible rash (left buttock only), thumb pain, brief leg "heaviness" (both) and fatigue, brief RLQ pain, increased tinnitus. The next evening: low back and neck (bone?) pain while attempting to sleep, out of character to usual back pain. By day 3 post injection, left nose tingling similar to onset of cold sore, which included left side of mouth the next day. By 7 days post injection, entire mouth area felt tingly similar to Novocaine wearing off. This lasted 3 days. Now improved. (took B-12 p.o.) Other brief episodes of chest discomfort, gum irritation, and anxiety. Vaccine #2 scheduled for 2/19/2021
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| 63 | 2021-02-18 | nausea, decreased appetite | Fever, chills, body pain, headache, nausea, loss of appetite, dizzy for 1 week. |
| 63 | 2021-02-21 | nausea, abdominal pain |
nausea, sharp abdominal pains, flushing, fever to 100.9 degrees F beginning the morning after secon...
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nausea, sharp abdominal pains, flushing, fever to 100.9 degrees F beginning the morning after second immunization (approx. 18 hours post) and lasting approx. 12 hours, some residual abdominal pain and nausea for an additional day
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| 63 | 2021-02-22 | nausea |
Trigeminal Neuralgia; Nausea; Chills; Body aches; Lightheadedness; Trigeminal nerve disorder; This i...
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Trigeminal Neuralgia; Nausea; Chills; Body aches; Lightheadedness; Trigeminal nerve disorder; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot: EL1284/expiration date not provided) via intramuscular route of administration, in left arm, on 19Jan2021 (at the age of 63 years old) as a single dose for COVID-19 IMMUNIZATION. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medication included losartan, amlodipine, metoprolol, esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EL0140/expiration date not provided) on 29Dec2020 (at the age of 63 years old) as a single dose in the left arm for COVID-19 immunization. On 20Jan2021, the patient experienced nausea, chills, body aches, lightheadedness, trigeminal nerve disorder. On 22Jan2021, the patient was diagnosed with trigeminal neuralgia. The events resulted in a physician office visit and Emergency Room visit. The seriousness criteria was disabling/incapacitating. The facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been not been tested for COVID-19. Treatment received for the events included steroids, anti-convulsant and pain relievers. The outcome of the events was not recovered. Follow-up (08Feb2021): New information from a contactable nurse (patient) includes: new event (trigeminal neuralgia), event details, seriousness criteria, treatment received and events outcome.; Sender's Comments: Based on the plausible temporal association and considering lacking alternative explanations, the Company cannot completely exclude the possible causality between the reported events, nausea, chills, body aches, lightheadedness, trigeminal nerve disorder, Trigeminal Neuralgia and the administration of the COVID-19 vaccine, BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 63 | 2021-02-23 | difficulty swallowing, nausea |
The injection was at 10:06am. At 10:07am felt nauseated and dizzy. Waited 15 minutes before proceedi...
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The injection was at 10:06am. At 10:07am felt nauseated and dizzy. Waited 15 minutes before proceeding home. At 10:31am throat began to close and tongue became swollen. Lips and gums were numb. Breathing became difficult as was swallowing. Rapid heartbeat. Called 911. Pt was taken to the hospital. Administered Benedryl and possibly a steroid. Stayed overnight in the hospital.
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| 63 | 2021-02-24 | abdominal discomfort |
FELT LIKE I HAD COVID AGIAN . BODY PAIN ,FEVER , GI UPSET . SHORT OF BREATH ,FATIGUE LASTED FOR...
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FELT LIKE I HAD COVID AGIAN . BODY PAIN ,FEVER , GI UPSET . SHORT OF BREATH ,FATIGUE LASTED FOR 4 DAYS
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| 63 | 2021-02-25 | abdominal pain |
Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Additional Detai...
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Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Additional Details: Patient stated she was experiencing some \"pressure and swelling under her upper ribcage\" and that she has had this reaction in the past when she accidently inhaled some chemicals. Patient was given one dose of Epinephrine IM into her left thigh and felt relief in pressure after 3 minutes. Patient was advised that if she experiences other symptoms to go to the ER.
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| 63 | 2021-02-25 | abdominal pain |
(2/25/2021) PATIENT REPORTS TO OFF-SITE COVID-19 VACCINE CLINIC. PATIENT FILLS OUT VACCINE CHECKLIST...
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(2/25/2021) PATIENT REPORTS TO OFF-SITE COVID-19 VACCINE CLINIC. PATIENT FILLS OUT VACCINE CHECKLIST AND IT IS NOTED THAT PATIENT HAS PREVIOUS ISSUES WITH FLU SHOT WITH A HISTORY OF TORUBLE BREATHING. TEACHING IS PROVIDED WITH PATIENT REGARDING POSSIBLE SIMILAR REACTIONS WITH COVID-19 VACCINE AND THAT SHE SHOULD STAY AT LEAST 30 MINUTES AFTER VACCINATION IF SHE WISHES TO PROCEED. PATIENT CONSENT TO PROCEED WITH COVID-19 VACCINATION. VACCINE IS GIVEN AT 1000 INTO RIGHT ARM AND PATIENT IS ASKED TO STAY FOR OBSERVATION. AT 1030 PATIENT REPORTS TO THIS NURSE ITCHING AND HIVES. PATIENT IS OBSERVED TO HAVE HIVES COVERING BILATERAL ARMS AND CHEST. PATIENT DENIES BREATHING TROUBLE AT THIS TIME. EMERGENCY REACTION KIT IS BROUGHT TO PATIENT?S TABLE. AT 1032 ON CALL PROVIDER IS NOTIFIED OF REACTION AND ORDERS ARE GIVEN FOR BENADRYL 50MG IM. THIS IS GIVEN AT 1034 RN INTO GUTEAL AND PATIENT IS OBSERVED AND VS OBTAINED. AT 1040 PATIENT STATES HER THROAT FEELS ?SCRATCHY? AND ?TIGHT.? IT IS RECOMMENDED TO PATIENT SHE SHOULD BE SEEN IN THE EMERGENCY ROOM. PATIENT AGREES TO THIS IF SHE IS ABLE TO DRIVE HERSELF. PATIENT IS FOLLOWED IN HER VEHICLE TO EMERGENCY ROOM FROM OFF-SITE CLINIC (APPROX. 8 BLOCKS). ON CALL PROVIDER IS NOTIFIED AND HOSPITAL EMERGENCY ROOM IS GIVEN REPORT FROM THIS NURSE. UPON ARRIVAL TO ER PATIENT IS SEEN PER MD. PATIENT REPORTS SYMPTOMS OF CHEST PRESSURE, DYSPNEA, LIGHT HEADEDNESS, ABDOMINAL PAIN, RASH, REDNESS, WARTHM AND ITCHING. PATIENT IS GIVEN 0.4 MG SUBCU ADRENALINE AND 40 MG PREDNISONE ORALLY. PATIENT IS OBSERVED IN EMERGENCY ROOM x 1 HOUR. PATIENT REPORTS SHE IS STARTING TO FEEL BETTER. PATIENT IS DISCHARGED TO AT 1206 FROM EMERGENCY ROOM.
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| 63 | 2021-02-25 | decreased appetite |
anxious; chills; No appetite; metallic taste in her mouth/ had a burnt taste in her mouth; burning s...
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anxious; chills; No appetite; metallic taste in her mouth/ had a burnt taste in her mouth; burning sensation in her whole torso; fast heart rate; This is a spontaneous report from a contactable consumer reported for self and a contactable consumer (husband). This 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 09:00 on Arm left via Intramuscular at single dose (Lot # EL3247) for covid-19 immunisation. Medical history included allergic to penicillin when she was a kid. She said that her lips swelled up. No other products. Since receiving the vaccine, she's had a burnt taste in her mouth on 20Jan2021 and also reported that she had a burning sensation in her whole torso that lasted 2-3 mins after she received vaccine on 20Jan2021 and her heart rate was racing but resolved after a few minutes. She had a metallic taste in her mouth. It made her very anxious and she was having a fast heart rate on 20Jan2021. She got panicky because of the metallic taste. She clarified that the burning sensation she felt was a burning in her whole torso on 20Jan2021 and it was extremely hot like a chemical went into her body that was burning her guts. She said that the burning sensation only lasted 2-3 minutes and was gone. She said that she got scared and her heart was racing a little bit on 20Jan2021. Her heart racing resolved that same day after a little bit. She clarified that she has like a burnt taste in her mouth. She said that it is the roof of her mouth and her tongue that taste like this. The burnt taste is still ongoing. She said that she tried to call the physician, but has not heard back yet. She said that she had chills and no appetite that day on 20Jan2021, but it was gone by the next day 21Jan2021. Outcome of the event metallic taste in her mouth/ had a burnt taste in her mouth was not recovered. Outcome of the event burning sensation, fast heart rate was recovered on 20Jan2021. Outcome of the events chills and no appetite was recovered on 21Jan2021. Outcome of other event was unknown.
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| 63 | 2021-02-25 | indigestion |
Inflammation on right side of neck throat and back area. Causing choking feeling of right side of n...
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Inflammation on right side of neck throat and back area. Causing choking feeling of right side of neck/ throat for approx. 8-10 hrs. .............Took several days to a gradual subsiding. Pressure felt in back of neck as well.... Same side loud tinnitus in right ear....took a couple days to subside.........during heightened swelling in nick muscles chest/ heartburn. Subsided after a short while.
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| 63 | 2021-02-25 | nausea |
got dizzy; felt queasy; Temp was lightly elevated; Sore injection site; Could not sleep, very uncomf...
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got dizzy; felt queasy; Temp was lightly elevated; Sore injection site; Could not sleep, very uncomfortable.; Got hot and sweaty about 3 1/2 hours after shot.; Got hot and sweaty about 3 1/2 hours after shot.; administration_date=26Jan2021; other vaccine date = 26Jan2021; administration_date=26Jan2021; other vaccine date = 26Jan2021; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) via an unknown route of administration on left arm (L shoulder/Arm) on 26Jan2021 at 09:00 AM at the age of 63 years old at a single dose for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included RA (Rheumatoid arthritis), Penicillin allergy and covid-19 (The patient was diagnosed with COVID-19 prior to vaccination). Concomitant medications included leflunomide (ARAVA) at 20mg, once a day, daily vitamins and mesalamine 1/day. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Also reported administration date 26Jan2021; other vaccine date 26Jan2021. On 26Jan2021 09:00, the patient experienced sore injection site (shot was given very high on L shoulder/Arm). Felt like a sharp pain when given. Got hot and sweaty about 3 and an half hours after shot. Could not sleep, very uncomfortable. Next morning (on 27Jan2021), the patient was getting ready to eat breakfast and got dizzy and felt queasy. Temp was lightly elevated. Taking Tylenol to help control soreness. The patient assessed the events as non-serious. No treatment was received in response to the adverse event. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of the events administration_date=26Jan2021; other vaccine date = 26Jan2021 was unknown and patient was recovering from all other events. Information on the lot/batch number has been requested.
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| 63 | 2021-02-25 | nausea |
general aching joint pain, headache, spine pain not muscle pain felt like back was broken started ar...
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general aching joint pain, headache, spine pain not muscle pain felt like back was broken started around midnight lasted untill late evening. left thigh pain like someone was doing a vein stripping. nausea no vomiting. Felt bad for 2 days. reddness on left arm not at shot site with left arm pain for 2 days. reddness in lt arm still there 02-26-2021.Red raised area warm no drainage.
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| 63 | 2021-02-26 | nausea |
Starting a couple hours after vaccination, I began to feel unwell, overall poorly, nothing specific....
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Starting a couple hours after vaccination, I began to feel unwell, overall poorly, nothing specific. Went to be early at 9:30 and awoke at one a.m.on February 26 with splitting headache. Could not get back to sleep well and felt terrible all that day with headache, nausea, and foggy thinking, not funcional after about 2:30 p.m. Took Ibuprofen at 3 p.m., called doctor and went to ER at Medical Center. Was seen at ER a few hours later. Slept some in waiting room. Had sore throat, the worst splitting migraine type headache ever, and was extremely foggy headed, couldn't process thoughts, eyes had difficulty focusing, nausea. My temperature was a little high for me, I am normally low and it was 99. My blood pressure is usually low and it was 105/59, pulse was 82 and respiration was 16 with 96 % Oxygen Saturation. They did tests and had an ophthalmoligist give me an exam also. They said I could go home with the same meds they were giving me in the hospital since they were working to alleviate my painful headache, 600 mg of ibuprofen, reglan and benadryl. Before I left they gave me the potassium chloride. I am continuing my medications today, two days after my vaccine.
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| 63 | 2021-02-26 | vomiting, diarrhea | Cold chills, diarrhea, vomiting, shortness of breath, muscle soreness, light headed |
| 63 | 2021-02-27 | nausea | intermittent nausea |
| 63 | 2021-02-28 | difficulty swallowing |
Low grade fever (100.3) after one week with progressive weakness, fatigue and swallowing dysfunction...
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Low grade fever (100.3) after one week with progressive weakness, fatigue and swallowing dysfunction analogous to exacerbation of her autoimmune disease (LUPUS) which had been in remission (on medication) for 5 years.
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| 63 | 2021-02-28 | nausea, vomiting |
PATIENT HAD A SEVERE ALLERGIC REACTION TO THE VACCINE. A COUPLE OF HOURS AFTER THE VACCINE, SHE HAD ...
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PATIENT HAD A SEVERE ALLERGIC REACTION TO THE VACCINE. A COUPLE OF HOURS AFTER THE VACCINE, SHE HAD SHORTNESS OF BBREATH, CHEST TIGHTNESS, NAUSEA AN VOMITING, FACE NUMBNESS AND TINGLING, AND HIGH BLOOD PRESSURE.
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| 63 | 2021-03-01 | indigestion |
This is the 2nd time since my 2nd shot my throat neck glands are big and sore & thyroid is swelled u...
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This is the 2nd time since my 2nd shot my throat neck glands are big and sore & thyroid is swelled up & sore difficult to swallow. Extreme long lasting exhaustion. Body is weak & sore muscles & joints. I have not been ok since my 2nd shot. I had a hard marble lymph node in my neck after the 2nd shot too.
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| 63 | 2021-03-02 | abdominal pain, nausea |
COVID shots Shot Feb 1, 2021 Day one of shot fatigue Day two of shot thigh cramps Day three of shot ...
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COVID shots Shot Feb 1, 2021 Day one of shot fatigue Day two of shot thigh cramps Day three of shot nausea Day four of shot back and joint pain Day five of shot sick feeling aching all over. Muscle and joint pain and fatigue. Chest pressure, cough, Hoarse voice Day six of shot headache fatigue pain through right eye. 2/5Temp 96.6, 98.6, 1:00pm SPO% 93% Resting heart rate 90 6:30pm SPO% 89%-91% Resting heart rate 102 Tylenol 100 mg 9:00am, 3:30pm TEMP 4:30pm 99.7* Symptoms of the freezing chest and cough as well as headache and feeling poorly kept rising several times a week. Covid 3/1/21 Covid symptoms return just like after Covid 19 1st vaccine. Body aches, joint pain, Chest pain, muscle aches, frozen feeling in lungs, cough, abdominal pain,eye ache, headache and fever. Temp 95.5 SPO 89% - 94% Resting heart rate 92 - 95 (After Covid shot 89%SPO, RHR 105, temp 99.7) 12:25pm temp 99 2/2/21 Feeling a little better. Still fatigue and ill feelings. At nighttime cough comes back with freezing lung feeling. Also started and body aches and joint stiffness. Went to bed took ibuprofen. 2/3/21 Still feeling ill . Woke with productive cough a little looser. Headache fatigue just feeling crummy.
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| 63 | 2021-03-02 | abdominal pain | LOW GRADE FEVERS 100.1, LEFT UPPER QUADRANT ABDOMINAL PAIN |
| 63 | 2021-03-02 | diarrhea |
2/28 6pm face flushed and puffy 10pm anxiety on guard, trouble sleeping 3/1 6am hea...
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2/28 6pm face flushed and puffy 10pm anxiety on guard, trouble sleeping 3/1 6am heart rate 108, no temp scratchy throat 10am diarrhea ; unease and rapid heart rate continue 5pm read about adverse events, called doctor, took Benadryl and began to feel better. 3/2 am communicated with doctor and she advised holding off on second shot, next steps tbd
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| 63 | 2021-03-02 | diarrhea |
Immediately after second dose of Pfizer Covid-19 vaccine given, patient developed a yellow bruise at...
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Immediately after second dose of Pfizer Covid-19 vaccine given, patient developed a yellow bruise at injection site. She reports feeling like a foreign body in injection site and reports feelings of tightness, pressure, and heat at site. Patient developed swelling of right arm over the next 3 weeks. Patient saw her PCP on 2/12/21 and an ultrasound was done to R arm. Results were negative. Five to six weeks post vaccine administration, patient is reporting weight loss over 10 pounds, possible hair loss, loose stools, and sweaty palms and feet. She also reports the right arm pressure and tightness is now radiating to her upper back.
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| 63 | 2021-03-03 | nausea | Chest pain radiating to back with associated nausea, transient hypertension |
| 63 | 2021-03-03 | nausea |
Pt received 1st dose of Pfizer Biontech vaccine. Patient reported history of anaphylactic reactions....
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Pt received 1st dose of Pfizer Biontech vaccine. Patient reported history of anaphylactic reactions. Pt told to stay 30 minutes for observation. During observation patient reported feeling itchy. VS taken at clinic and were stable: HR 88, BP 135/66 Spo2 94%. Patient's face was slightly red without edema. She reported breathing okay but felt a little tight in her throat. Sent to ER for management. Per ER note "63 year old female with a complex medical history including lupus, scoliosis, Sjorgen's syndrome, and anaphylaxis requiring intubation presents complaining of itching and dizziness following COVID 19 vaccination with the Pfizer mRNA vaccine...patient's exam demonstrates itchy red welts consistent with urticaria and she endorses a foreign body sensation in her throat. Examination of the oropharynx demonstrates uvular edema without stridor. The patient endorses chest tightness but does not have wheeze on exam...endorses nausea. Diagnosed with anaphylactic reaction. Patient received epinephrine 0.3 mg IM, diphenhydramine 50 mg IV, famotidine 20 mg IV, and methylprednisolone 125 mg IV along with albuterol MDI. Had improvement in symptoms within an hour, observed for 6 hours without recurrence of symptoms and was discharged home. Advised not to receive second dose of vaccine until discussion with allergist occurred.
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| 63 | 2021-03-05 | difficulty swallowing |
No issues during 15 minute observation period after receiving the vaccine. So I left the facility to...
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No issues during 15 minute observation period after receiving the vaccine. So I left the facility to go to my car. Then about 15 minutes later my face started to get really hot with slight swelling. Then after several more minutes throat became tight and started to experience extreme difficulty swallowing. I was still in the parking lot so I immediately went back inside to the vaccination area asking for help. I did not experience any breathing difficulties during the entire time but did experience extreme difficulty with swallowing and throat tightening. The staff did the usual checks. I was not too awarre of all the things they did but I was given a benedryl tablet which I was able to swallow thankfully. I was told my vitals were very high. Not sure of exact times but sometime shortly after the benedryl things started to fell better. The throat/swallowing started to get better. Face burning started to cool. Stayed in this area for about 20 or 30 more minutes and then told I could go with a comment that I should see my doctor about my high blood pressure. Which I explained I do not have high blood pressure and when checked later in the day it was back to my usual 115 - 125 range . I was concerned about getting the second shot later and was told to take a benedryl either just before I get the next shot or right after.?????? After checking the online cdc guidelines that does not jive at all.
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| 63 | 2021-03-07 | nausea |
HAD WAVES OF NAUSEA STARTING ON THURSDAY FEBRUARY 25TH ,THEN NAUSEA EVER SINCE ,NOW WHEN I GO TO BE...
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HAD WAVES OF NAUSEA STARTING ON THURSDAY FEBRUARY 25TH ,THEN NAUSEA EVER SINCE ,NOW WHEN I GO TO BED I WAKE UP WITH NAUSEA. HAD VIRTUAL VISIT WITH DOCTOR AND SHE PRESCIBED SOME ANTI NAUSEA MEDS AND THIS MORNING WENT TO ER,PRESCRIBED MORE ANTI NAUSEA MEDS . . NOT SLEEPING BECAUSE OF THE NAUSEA. HAVE PC APPOINTMENT TOMORROW .
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| 63 | 2021-03-07 | nausea |
classic migraine-type headache 03/05-present overall muscle ache 03/05-present fatigue 03/05-prese...
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classic migraine-type headache 03/05-present overall muscle ache 03/05-present fatigue 03/05-present nausea 03/05-present L foot & ankle swelling 03/06-present
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| 63 | 2021-03-08 | diarrhea |
As expected, I was sore after the first injection, but waited until bedtime to take Tylenol. I did t...
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As expected, I was sore after the first injection, but waited until bedtime to take Tylenol. I did that in order to sleep better. I did have a lot of stool prior to bedtime, but didn?t think much of it, as I had a lot of water, and thought it might be due to nerves and eating a larger dinner than typical. I went to work, had lunch, and shortly after had explosive diarrhea. I went to clock out, felt weak, and had another episode. I took immodium so I could drive home, had 2 more bouts, took one more immodium, and have not had more. I do feel tender, but am not running a fever. I presume this is not related to the vaccine, but was advised to let you know.
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| 63 | 2021-03-08 | diarrhea |
Beginning a few hours after the vaccine the day of the vaccine and into the next AM, I had diarrhea...
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Beginning a few hours after the vaccine the day of the vaccine and into the next AM, I had diarrhea. 30 hours after receiving the vaccine, I woke up at 3 AM with itching all over my body. I had hives on both eyes. I called my Dr., who scheduled me to come in for an office visit. She examined me and recommended that I proceeded to the ER for further monitoring. There they examined me and prescribed Benadryl for 5 days and Zantac for its antihistamine properties, as well as prescribing an EpiPen. It turned out that Zantac has been removed from the market, so I have just taken Benadryl.
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| 63 | 2021-03-08 | diarrhea | Diarrhea for 4 hours Chills and Low Body Temperature (below 96 degrees) for 4 Hours |
| 63 | 2021-03-09 | abdominal pain upper | Bad Stomach ache, chills, pain in lower left buttocks, fatigue |
| 63 | 2021-03-09 | diarrhea |
Onset of chills, body aches, joint pain, headache, diareah During night face turned bright red and b...
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Onset of chills, body aches, joint pain, headache, diareah During night face turned bright red and body felt hot General tired and achy lasting 4 days
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| 63 | 2021-03-09 | nausea |
Patient stated she felt nausea. Later became lightheaded and had to be transported to the Emergency ...
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Patient stated she felt nausea. Later became lightheaded and had to be transported to the Emergency Department.
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| 63 | 2021-03-10 | indigestion |
pulmonary embolism/Blood clots in the lung; heart attack; Shortness of breath; headache; jaw hurt; S...
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pulmonary embolism/Blood clots in the lung; heart attack; Shortness of breath; headache; jaw hurt; Shin hurt; heart burn; This is a spontaneous report from a contactable consumer (patient's son). A 63-year-old female patient (mom) received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration in arm in Feb2021 (reported as in the first week of Feb2021) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162B2 in Jan2021 for COVID-19 immunization. Reporter (patient's son) received his first dose of Pfizer COVID vaccine on Wednesday and wanted to know if this vaccine could cause blood clot. He stated his mom (patient) in the hospital due to pulmonary embolism from 24Feb2021, 2.5 weeks after her second shot. He stated his anxiety levels were higher than normal. He had strong response to flu vaccine this year and experienced chill, shakes, fever, received antibiotic, and loss sense of taste from the flu vaccine. Reporter read online that some people commented that they have DVTs (deep vein thrombosis) and blood clots from the Pfizer COVID vaccine. Patient experienced blood clots in the lung in Feb2021 and hospitalized on 24Feb2021. Patient got her second shot about 2 weeks before and she ended up in the hospital with pulmonary embolism. They looked at her lungs and found all the blood clots. Patient had really bad shortness of breath, headache, her jaw hurt, and her shin hurt. She was helping out at vaccine clinic and she was out of breath, she said the old people in strollers were passing her. Patient began to make complaints about how she was feeling in mid of Feb2021. Patient said in rare cases 2 weeks after the second dose reactions could happen. Patient got done working in ICU, and helped with PPE, then at 11 she left work at the hospital, she was experiencing heart burn for 3 days and so she thought had a heart attack drove to an ER (emergency room) on the way home, and then was admitted to the hospital on that same day 24Feb2021, she was supposed to be discharged today (26Feb2021). Patient had been feeling out of breath for past 2 month, it was possible it might seem like it was related to the vaccine but it could also not be related. Reporter stated that on the internet he saw how a 1000 deaths happened after the vaccine, it was all old people, but in the autopsies there was no link to the vaccine, they were going to die regardless. Lab data included: She did get a test before for Factor 5 Leiden but it was negative. They did test for COVID, it was negative, while in the hospital. In the hospital they were also testing her again for the Factor 5 Leiden, the results hadn't come back yet. They did test for blood clots, they did an MRI (magnetic resonance imaging) in Feb2021, it was positive for blood clots (blood clots in the lungs). When she was admitted her oxygen was 85%. Outcome of the events was unknown. Information on lot and batch number has been requested.
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| 63 | 2021-03-10 | difficulty swallowing |
(Note; after 1st dose on February 1st had some tongue and lip tingling within 30 minutes, took Bena...
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(Note; after 1st dose on February 1st had some tongue and lip tingling within 30 minutes, took Benadryl 25 mg with relief). Prior to second dose, took Benadryl 25 mg at 310pm.... at 350pm, received second dose of Pfizer vaccine.... tingling of lips and tongue within 10 minutes, took Benadryl 25 mg at 4pm...?. progression of tingling of tongue to some numbness of tongue, towards back of throat, some difficulty swallowing, throat hoarseness, chest discomfort, sporatic spot itching of eyeballs - shoulder-forehead-top of right arm. Went to Emergency room around 5pm.... given corticosteroid and Pepcid IV... with relief. Left Emergency room around 730 with minimal tingling of tongue....no other symptoms. Took Benadryl 25 mg by mouth before bed. 3/6/21- woke up with no symptoms.
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| 63 | 2021-03-10 | nausea |
Pfizer-BioNTech COVID- 19 Vaccine EUA Approximately 5 minute post vaccination, patient experienced c...
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Pfizer-BioNTech COVID- 19 Vaccine EUA Approximately 5 minute post vaccination, patient experienced chest pain radiating down left arm, shortness of breath, and nausea. Patient also endorses numbness to left upper arm and left lower leg. Denies any wheezing, throat swelling, facial swelling, diarrhea, urticaria. Vitals: BP 104/65, Pulse 78, SpO2. On chart review, she had similar symptoms in the past with full stroke workup that was ultimately determined to be conversion disorder. Admitted for observation to rule out ACS. EKG and serial troponin unremarkable.
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| 63 | 2021-03-10 | stomatitis |
pt stated that she got really warm within a couple of minutes of getting the vax. Pt got tightness...
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pt stated that she got really warm within a couple of minutes of getting the vax. Pt got tightness under eyes, checks, and inside her mouth. She had some pinching feelings in her chest which she said this may be acid reflux. Her right leg was hurting near her ankle and foot. Nurse at vax site checked her stats and everything was normal. She was given Benadryl. These symptoms subsided. After getting home she had some tickling in her throat. Pt only has soreness and redness in her left arm today.
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| 63 | 2021-03-11 | nausea, vomiting |
extreme dizziness, nausea and vomiting for 9 hours fast heartbeat, palpitations for 9 hours overlapp...
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extreme dizziness, nausea and vomiting for 9 hours fast heartbeat, palpitations for 9 hours overlapping headache
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| 63 | 2021-03-11 | nausea |
ADVERSE EVENTS: INJECTION SITE PAIN, TIREDNESS, HEADACHE, MUSCLE PAIN, CHILLS, JOINT PAIN, FEVER (1...
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ADVERSE EVENTS: INJECTION SITE PAIN, TIREDNESS, HEADACHE, MUSCLE PAIN, CHILLS, JOINT PAIN, FEVER (101.9 DEGREE F @ 2 AM 3/11/21 & BETWEEN 100.6 - 99.6 THROUGH THE EVENING 3/11/21), NAUSEA, FEELING UNWELL, SWOLLEN LYMPH NODE. TREATMENT: TYLENOL EVERY 4 HOURS STARTING AT 8 AM 3/11/21. SYMPTOMS SUBSIDED THROUGH THE LATE NIGHT OF 3/11/21 EXCEPT SWOLLEN LYMPH NODE & INJECTION SITE PAIN STILL PERSISTS 3/12/21.
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| 63 | 2021-03-11 | vomiting |
Vomiting (vomited about eight times); massive headache; chills; sweats; and fatigue. Lasted another ...
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Vomiting (vomited about eight times); massive headache; chills; sweats; and fatigue. Lasted another 30 hours.
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| 63 | 2021-03-12 | vomiting |
Started vomiting, feeling lethargic . Bumpy raised red itchy rash started on my arm at injection s...
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Started vomiting, feeling lethargic . Bumpy raised red itchy rash started on my arm at injection site, but then to underneath my arm on both sides of my body and proceeded to my neck, chest, over my back, torso, abdomen and rib cage. Even the bottoms of my feet look like they have red itchy blotches and the palms of my hands????? Also developed an On and off again painful left temple headache.... thought I was going to have a stroke or some thing! That comes and goes for one week now. , slight fever for two days, and then the pain and set in: GOUT LIKE I?VE NEVER EXPERIENCED!
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| 63 | 2021-03-13 | abdominal pain upper | Tiredness, muscle aches, stomachache. Rash on Neck |
| 63 | 2021-03-13 | diarrhea | Mild headache, moderate diarrhea, chills |
| 63 | 2021-03-13 | difficulty swallowing |
Fever, coughing er visit bronchitis 3/4/21 Sore throat, pus on sides of tongue and tonsils unable to...
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Fever, coughing er visit bronchitis 3/4/21 Sore throat, pus on sides of tongue and tonsils unable to swallow, pain in both ears 3/13/2021 return to er, fever both times 101. I was doing good until I got the shot
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| 63 | 2021-03-13 | nausea, abdominal pain upper | epigastric pain, nausea, clammy, chills Hospitalized inpatient Hospital |
| 63 | 2021-03-13 | nausea | Headache, Fever, Chills, Muscle Aches, Nausea |
| 63 | 2021-03-14 | decreased appetite |
Headache; Swollen lymph nodes on her neck; Dizziness; Her feet felt swollen and she hurt when she wo...
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Headache; Swollen lymph nodes on her neck; Dizziness; Her feet felt swollen and she hurt when she would step down; Loss of appetite; She slept all day; Muscle pain; Chills; Joint pain; Fever; Feeling unwell; Injection site pain; Tiredness; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9264B), intramuscular on 01Feb2021 at single dose for COVID-19 vaccination. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3249) on 11Jan2021 for COVID-19 vaccination. Caller was a consumer that was calling about the Covid-19 vaccine and said that she wanted to report her symptoms after the Covid-19 vaccine. Caller reported that she experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain on, fever, feeling unwell, her feet felt swollen and she hurt when she would step down, loss of appetite and she slept all day on 01Feb2021, swollen lymph nodes on her neck and dizziness on 02Feb2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The seriousness was reported as non-serious. The outcome of the events injection site pain, chills, fever, swollen lymph nodes on her neck, dizziness, her feet felt swollen and she hurt when she would step down, loss of appetite and she slept all day were recovered and other events were recovering.
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| 63 | 2021-03-14 | burping | Tachychardia, chest pressure, belching, hard to take a full breath |
| 63 | 2021-03-14 | nausea, retching | Nausia, dry heaves |
| 63 | 2021-03-14 | nausea |
Both upper arms and upper back have extreme burning pain and tightness. All of my muscles ache. Bo...
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Both upper arms and upper back have extreme burning pain and tightness. All of my muscles ache. Both calves felt weak. Extreme fatigue. Increased ear ringing. Sinus and head pressure. Slight queasiness. When the shot was first given, I had immediate pain at the injection site and up my neck. As the day progressed I felt tired, achy all over. The burning, stinging pain increased, in both arms and upper back. It seems worse at night and wakes me up. It is severe enough that it makes me cry. I have used regular strength Tylenol, Regular strength Advil and Allegra, as treatment. The burning pain continues. So does the muscle aching and fatigue.
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| 63 | 2021-03-14 | nausea |
Beginning at approximately 9pm on 03/13/2021, my upper arm became very sore and nausea started. By...
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Beginning at approximately 9pm on 03/13/2021, my upper arm became very sore and nausea started. By 7am on 03/14, I was extremely chilled and still nauseated, however my arm soreness was subsiding. I fell back to sleep and woke up about 2pm. I had finally warmed up but still slightly nauseated. By 6pm, I ate some dinner and today, 3/15, I feel normal.
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| 63 | 2021-03-14 | nausea |
Patient started to have mild queasiness about 20 minutes after vaccine was given. Within a few minut...
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Patient started to have mild queasiness about 20 minutes after vaccine was given. Within a few minutes of the queasiness, patient started to feel dizzy and nauseous. Patient endorsed feeling "not quite right". Patient was brought over to paramedics for further observation. VS taken over the course of ~1 hour prior to patient being transferred to ED. Transport occurred on date of vaccination. On post-vaccine Day #1, pt continued to endorse some dizziness. Also noted to have SOB, headache, and mild body aches with a brief episode of chills. On post-vaccine Day #2, pt still felt SOB, more upon exertion. Pt had to use rescue inhaler every 4 hours, which helped pt "breathe and relax a little bit."
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| 63 | 2021-03-15 | nausea |
Fever; Chills; Achiness; nausea; flu-like symptoms; waking up over night; This is a spontaneous repo...
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Fever; Chills; Achiness; nausea; flu-like symptoms; waking up over night; This is a spontaneous report from a contactable consumer. A 63-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), on Left upper arm via an unspecified route of administration on 27Jan2021 2:30/3 PM at single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. The patient previously took first dose (lot number: EJ1685, EXP: 31Mar2021) at 4:30 PM for covid-19 immunisation. Caller says she got this number from the pamphlet that was given to her when she gotten her first dose of the Pfizer COVID Vaccine. She got the second dose yesterday. Early this morning (around 2 or 3 AM this morning 28Jan2021) in the middle of the night she started having flu-like symptoms. She was calling to make sure to report them and she wanted to know if it was okay to take Tylenol. She cannot remember if the people who gave her the vaccine said if she could take Tylenol if she needs it. She had a fever this morning of 100.6. She also has chills and achiness. She volunteers at a healthcare facility, which is where she got the vaccine. She will call them about it. Got the second dose yesterday 27Jan2021. She kept waking up overnight and could not get warm. She just was unable to get warm. It was early this morning. She had went to be around 11:30 PM and felt perfectly fine. She tried to drink OJ and keeps trying to drink lots of water. She ate some protein, some cheese. She was concerned not to eat because she did not want to counter balance the nausea and it get worse. She had a tinge of nausea this morning. Outcome of the events nausea and flu-like symptoms was unknown, Outcome of the event waking up over night was recovering. Outcome of the other events was not recovered. Information on the Lot/Batch number has been requested
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| 63 | 2021-03-15 | nausea |
Tiredness Headaches Chills Joint pain Nausea Feeling unwell Took Motrin Ate light Slept Kept moving ...
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Tiredness Headaches Chills Joint pain Nausea Feeling unwell Took Motrin Ate light Slept Kept moving All side effects ceased after 24 hours except tiredness.
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| 63 | 2021-03-16 | nausea |
I felt fine immediately after the injection, but then about 3 minutes after the injection, I was "hi...
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I felt fine immediately after the injection, but then about 3 minutes after the injection, I was "hit" by a very intense reaction: metallic taste in mouth, nauseous, burning heat throughout my back, sweating, very hot, very anxious/scared. This quieted down after about 10 minutes, but then I got "hit" again, a few minutes after that. This time with burning heat in my chest and then burning heat traveling down my left arm, sweating, very hot, very anxious/scared. I was under observation for 45minutes before they let me drive home (just 4 miles away). Once I got home, I felt extremely exhausted and foggy headed. This lasted for about 6 hours, and then it began to lift. That night, I was woken from sleep suddenly by pain in my arm (at injection site); it was a sort of pain I've never experienced -- it was sharp and moving around. The following day (today) I'm having lingering fatigue, lingering slight nausea, and a sore arm at injection site.
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| 63 | 2021-03-16 | vomiting, diarrhea | body aches, sweats, vomiting/diarrhea, |
| 63 | 2021-03-16 | vomiting |
patient is a 63 y/o F who had her Covid 19 Pfizer vaccine 1st dose on 3/10/2021 and began feeing bad...
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patient is a 63 y/o F who had her Covid 19 Pfizer vaccine 1st dose on 3/10/2021 and began feeing bad that evening , had 1 emesis episode and felt "crummy" with fatigue/weakness/sweats/malaise for 3 subsequent days without recorded fever, rash , change in color of urine but decreased oral intake and began to feel better 3/14 Sun, she then awoke with Heart racing and presented to our ER 0300 3/15 with A fib with RVR which resolved after approx 30 min while receiving IV fluids in ER without other treatment. She was treated and released to followup here today 3/17/21 at our office. I noticed on routine ER labs that she had elevated transaminases (ALT/AST) in 300 unit range (normal up to 40-50) which she has never had on previous panels with normal bili, alk phos , and otherwise normal CMP. At the time of followup her EKG was normal and she has had no further symptoms but transaminases are redrawn and she is advised not to get her second Covid shot. Patient is elderly CHADS VASC score is 1, nonsmoker , family hx of heart disease.
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| 63 | 2021-03-17 | difficulty swallowing |
Immediate taste in mouth. Rash on neck and face. Slight throat swelling, slight difficulty swallowi...
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Immediate taste in mouth. Rash on neck and face. Slight throat swelling, slight difficulty swallowing. Very faint dizziness, fatigue.
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| 63 | 2021-03-17 | nausea |
Started with joint and muscle aches at 5:30 on 3/17, by 9:30pm, very painful to take a deep breath, ...
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Started with joint and muscle aches at 5:30 on 3/17, by 9:30pm, very painful to take a deep breath, chills, fever of 100.2, injection site left arm throbbing, tired and weak, slight headache and nausea. Tired and weak, achy and slight headache when woke up on 3/18. Still somewhat painful to take a deep breath and injection arm painful. Tylenol 2 tablets at 8:30 am and 2:30pm on 3/18
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| 63 | 2021-03-18 | abdominal pain upper, vomiting |
Chills; stomach pain joints; vomit; weak blood pressure; stomach pain joints; This is a spontaneous ...
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Chills; stomach pain joints; vomit; weak blood pressure; stomach pain joints; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm at 63-year-old (not pregnant at the time of vaccination) on 03Mar2021 at 16:00 (lot number: EN6198, expiration date unknown) at single dose for COVID-19 immunization. Medical history included diverticulitis. No known allergies were reported. The patient was not diagnosed with COVID prior vaccination. Concomitant medications were reported as unspecified other medications in two weeks. No other vaccine in four weeks. On 04Mar2021 at 06:00 AM the patient experienced chills stomach pain joints vomit weak blood pressure (as reported). The events resulted in hospitalization. The patient underwent lab tests and procedures which included nasal swab: negative on 04Mar2021. No COVID tested post vaccination. It was unknown whether treatment was received. The outcome of the events was not recovered.
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| 63 | 2021-03-18 | diarrhea, nausea |
joint pain, chills, nausea, dizziness, HA, chest is heavy, diarrhea X1 episode, spoke to doctor who ...
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joint pain, chills, nausea, dizziness, HA, chest is heavy, diarrhea X1 episode, spoke to doctor who stated the symptoms are "normal", clarified if she mentioned the dizziness & heaviness to chest, reported she did and her pcp stated it was again "normal". informed her those reported symptoms should be checked in the ED for potential cardiac events. Caller verbalized understanding.
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| 63 | 2021-03-18 | nausea |
Patient had Pfizer vaccine 1st dose on Tuesday AM . Later that night, starting into Wednesday morni...
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Patient had Pfizer vaccine 1st dose on Tuesday AM . Later that night, starting into Wednesday morning started to feel terrible - sore arm, headache, severe body aches, fever, chills, nausea. Continued through to Thursday. Pt started to feel intermittent SOB, difficulty with getting in air. This subsided after some time. NO rash, hives, tight airway, vomiting. Patient reports today feels a little better but entire body still has burning sensation. Going to Urgent care for evaluation.
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| 63 | 2021-03-18 | nausea |
Next morning (7am) sweating, nauseous, blurred and double vision, and dizziness Went back to bed f...
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Next morning (7am) sweating, nauseous, blurred and double vision, and dizziness Went back to bed for about 2 hours and woke up with slight dizziness. Sweats and nausea were gone
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| 63 | 2021-03-18 | nausea |
Patient complain of feeling dizzy an d nauseous. EMS on site came over and assess patient, took her...
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Patient complain of feeling dizzy an d nauseous. EMS on site came over and assess patient, took her vital signs. B/P 118/77, P84, R 18, Oxygen 98% on room air. Patient refused transport to the hospital. EMS monitor patient for 15 minutes, then she stated she felt better and wanted to leave, she was instructed to wait in observation for another 15 minutes.
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| 63 | 2021-03-19 | diarrhea, nausea | Extreme Nausea Diarrhea Body Aches Chills Neck ache |
| 63 | 2021-03-19 | difficulty swallowing |
APPROXIMATELY 20 MINUTES AFTER THE PATIENT RECEIVED THE VACCINE SHE DEVELOPED DYSPNEA, SUBJECTIVE DI...
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APPROXIMATELY 20 MINUTES AFTER THE PATIENT RECEIVED THE VACCINE SHE DEVELOPED DYSPNEA, SUBJECTIVE DIFFICULTY SWALLOWING AND MENTIONED TONGUE SWELLING/PARESTHESIA OF THE LIPS. SHE WAS RAPIDLY ATTENDED TO; AN EPIPEN WAS ADMINISTERED IN LEFT THIGH AND SYMPTOMS PERSISTED. EMS WAS CALLED AT 5:20PM. VITAL SIGNS WERE MONITORED AND RECORDED. SHE LATER REPORTED CHEST PRESSURE; EMS ARRIVED AND SHE WAS TAKEN TO THE HOSPITAL.
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| 63 | 2021-03-20 | nausea, vomiting |
I woke up feeling very nauseous and my head started hurting. It got a little better during the day, ...
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I woke up feeling very nauseous and my head started hurting. It got a little better during the day, but returned about 4 or 5 PM and proceeded to get much worse. I tried taking Zofran and Tylenol about 10 and they helped a little. Around midnight I threw up and then started feeling much better. I'm not totally convinced it was from the vaccine.
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| 63 | 2021-03-20 | vomiting | Vomiting then 101.8 fever then extreme fatigue 29 hours. |
| 63 | 2021-03-21 | diarrhea |
Violent, explosive diarrhea! Holy cow! Not fun at all. Started mildly about 5 hours after injection...
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Violent, explosive diarrhea! Holy cow! Not fun at all. Started mildly about 5 hours after injection. The next day - OMG - horrible! First regular poop on 03/22/21.
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| 63 | 2021-03-21 | nausea |
Four days after the shot my eye someone told me my eye was red. I had a hemorrhage in my left eye. I...
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Four days after the shot my eye someone told me my eye was red. I had a hemorrhage in my left eye. It was the outside of my eye but there was no pain. It lasted about five days. Seven days after the first vaccine I also had an eye hemorrhage in the same are of my eye. The doctor could not find anything wrong with my eye. Other symptoms included a few waves of Nausea and a low -grade fever.
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| 63 | 2021-03-21 | nausea |
I have been experiencing dizziness/vertigo and mild nausea since the day I received the vaccine. It ...
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I have been experiencing dizziness/vertigo and mild nausea since the day I received the vaccine. It has not gotten better or worse. Just through out the day it comes and goes.
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| 63 | 2021-03-21 | nausea |
Shortly after sitting down after vaccination, felt as body was exploding, either from sudden drop or...
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Shortly after sitting down after vaccination, felt as body was exploding, either from sudden drop or sudden rise in blood pressure. Then severe vertigo set in, everything started spinning and nausea set in. Waited for 30 minutes and vertigo was better, but not totally gone, but nausea was still there. Left facility and nausea abated after 1.5 hours. Vertigo continued for 48 hours but fairly mild. Caused me to walk like a drunk person but no dizziness any more. Then at 10:30 PM torso broke out in hives that lasted about one hour. No hives on arms and legs.
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| 63 | 2021-03-22 | difficulty swallowing |
Client c/o difficulty swallowing and feeling of heaviness in the tongue. Client seen and assessed b...
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Client c/o difficulty swallowing and feeling of heaviness in the tongue. Client seen and assessed by EMT and all vitals were within normal limits. 15 minutes within observation, client stated that she was able to swallow and client observed drinking water without problem. Client cleared to go home by EMT.
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| 63 | 2021-03-23 | decreased appetite, abdominal discomfort, nausea |
This is my second report, I had received my 2nd Pfizer vaccine on 2/23/2021.On 2/24/2021I was a litt...
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This is my second report, I had received my 2nd Pfizer vaccine on 2/23/2021.On 2/24/2021I was a little achy and that night felt a little nauseous On 2/25/2021 I began to experience strange waves of nausea during the day. . that night I continued with the nausea and for the next few days had stomach issues. then that Sunday night i woke up with strange nausea and discomfort .I was having this every night Some days I would be fine and others would feel little queasy on and off. I ended up at the ER on Monday March 8th ,they ran blood and urinalysis and no other tests . They told me the nausea would go away. I have been to my GP twice and one virtual visit . I have been on pepcid , zofran which didn't help .and now prozac and xanax at night . I may have one night that is good and then the nausea will return. I was not sleeping or eating and was getting anxiety from the nausea. My doctor thought it was a side effect from the vaccine and the ER doctor said its so new they just didn't know. This is week 4 now and I am headed to a gastroenterologist this week . I am a healthy 63 year old with no underlying health problems . I have had stomach aches and nausea before but this is definitely different.
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| 63 | 2021-03-23 | diarrhea, GERD |
Pfizer-BioNTech VOCID-19 Vaccine EUA 3 days after the injective, I had a bout of diarrhea. Since the...
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Pfizer-BioNTech VOCID-19 Vaccine EUA 3 days after the injective, I had a bout of diarrhea. Since them I had had increasing bowel movements each day. Yesterday I had 6 bowel movements, stomach gurgling, acid reflux. I am getting worse each day. I need to know what to do and if I should avoid the second shot.
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| 63 | 2021-03-23 | diarrhea | Sudden onset diarrhea.....lasted four hours |
| 63 | 2021-03-23 | nausea |
First felt coldness in elbow region and a little itchy. Nausea about 30 minutes later and coldness ...
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First felt coldness in elbow region and a little itchy. Nausea about 30 minutes later and coldness crept up arms, back and neck
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| 63 | 2021-03-23 | vomiting |
3-11-21 pain in groin on right side/leg weakness around 2:00pm better next day just sore arm., Fatig...
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3-11-21 pain in groin on right side/leg weakness around 2:00pm better next day just sore arm., Fatigue on 3-12 & 3-13. On 3-14 developed intense pain right side lower back and kidney. 3-16 went to Doctor as felt I had kidney infection but urine checked find, she thought it was muscle spasms. 3-19 broke out with shingles and back to doctor on 3-22 and given Acyclovir and Gabapentin. 3-23 went to ER. In as woke with pain so severe I broke out in sweat and threw up. Gave me Hydrocodone, nurse commented was worse break out she had ever seen. Internal pain is worse than the rash which is naval to spine and 3 to 4 " wide.
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| 63 | 2021-03-24 | abdominal pain upper |
On 3/5/2021 bad stomach ache lasting 5 days. 3/11 noticed what I thought were hives. Burning right ...
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On 3/5/2021 bad stomach ache lasting 5 days. 3/11 noticed what I thought were hives. Burning right side .. (back) then the shingles 3/22 called doctor...
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| 63 | 2021-03-24 | decreased appetite |
2 days following 1st Pfizer vaccine developed burning and stiffness, and pain in joints, followed by...
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2 days following 1st Pfizer vaccine developed burning and stiffness, and pain in joints, followed by severe pain in muscles "all over her body". She had severe headache. She had a fever of 101.9. She had no appetite and "could not eat" . She remained in bed, barely able to walk to the bathroom for 7-8 days. She was "so weak", could not get up. She did not have solid food for 1 week and was not able to take more than sips of liquid. She has continued weakness fever. Now 3 wks following the vaccine, her temp is 100.2.
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| 63 | 2021-03-24 | nausea, abdominal discomfort |
Extreme thirst, chills, full body muscle aches, dizziness, extreme fatigue (so much so I could barel...
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Extreme thirst, chills, full body muscle aches, dizziness, extreme fatigue (so much so I could barely keep my eyes open when driving after 8 hours of sleep the night before), nausea, stomach upset. Note: I have not had a flu shot for 25 years, nor have I ever had the flu during that time, but the symptoms do seem flu like. It is now end of day 2 following the 2nd dose of vaccine and I still feel incredibly icky.
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| 63 | 2021-03-24 | retching, vomiting |
PT REPORTED NON-STOP VOMITING THAT STARTED TUESDAY NIGHT 3/25/21 AROUND 8PM. IT DID NOT STOP UNTIL 1...
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PT REPORTED NON-STOP VOMITING THAT STARTED TUESDAY NIGHT 3/25/21 AROUND 8PM. IT DID NOT STOP UNTIL 1 AM THE NEXT DAY, 3/26/21. PT WAS DRY HEAVING EVERY HOUR ON THE HOUR UNTIL 1AM . REPORTS NO CHANGES IN DIET OR ACTIVITY TO CAUSE THE VOMITING.
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| 63 | 2021-03-25 | vomiting |
Eight days following first shot, my arm started itching near the injection location and two quarter ...
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Eight days following first shot, my arm started itching near the injection location and two quarter sized red spots showed up. This lasted a few days. 2nd shot was Mar 18 at 11 am at same facility. Had severe arm and shoulder blade pain the remainder of the day. Used an ice pack. Mar 19 had slight fever in the morning. Severe arm pain had resolved. Severe achiness in lower back and jaws and general achiness. Started taking Tylenol in afternoon. Vomited at 6pm and 10:30pm. Mar 19-21: Severe headache. Barely ate Mar 19-20. Stayed in bed or resting on couch. Experienced intermittent hiccups. No energy. Headache resolved. Mar 22. Mar 26. Still don't feel 100% normal energy level, but pretty much resolved
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| 63 | 2021-03-26 | abdominal pain upper | Severe stomach cramps |
| 63 | 2021-03-26 | difficulty swallowing |
Site: Swelling at Injection Site-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness...
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Site: Swelling at Injection Site-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Swelling of the injection site, jaw spasm, high blood pressure-Mild, Systemic: Hypertension-Mild, Additional Details: Patient started to have swelled injection site arm after about 30 minutes of vaccination but patient remained responsive. 11:40pm - BP 198/100, HR 72. 12pm- BP 198/100, HR 72 & complained of dystonia symptoms so we called 911 paramedics came within 5 minutes. 12:15pm- BP 240/110, HR 72. Called patient's daughter at 2:01pm (patient still in the ER), at 3:16pm (left message to voice mail). Patient did not mention she has history of dystonia after getting any vaccine when asked prior to vaccination
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| 63 | 2021-03-26 | nausea, abdominal discomfort |
Restlessness, pain at sight of arm, unable to sleep that night, agitated, sweats, heaviness in chest...
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Restlessness, pain at sight of arm, unable to sleep that night, agitated, sweats, heaviness in chest, no care attitude, muscle pain, headache, nausea- emptiness in stomach, possibly swollen lymph nodes. This continued until 6pm the next day (3/25/2021) after receiving the covid vaccine. Should I get the 2nd vaccine, scheduled for 4/15?
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| 63 | 2021-03-28 | decreased appetite, indigestion |
Adverse systemic events for the duration of March 17-March 27: Swollen lymph glands (mild) Fatigue (...
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Adverse systemic events for the duration of March 17-March 27: Swollen lymph glands (mild) Fatigue (severe) Brain "fog" (severe) Sensation of overheating / burning Fever (few mild elevations) Loss of Appetite /Indigestion (resolving as of March 26)
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| 63 | 2021-03-30 | abdominal pain |
dysuria; abdominal pain; pelvic pain; bladder spasms; left flank, low back and upper back pain; left...
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dysuria; abdominal pain; pelvic pain; bladder spasms; left flank, low back and upper back pain; left flank, low back and upper back pain; headache; This is a spontaneous report received from a contactable nurse. A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number: EL0142) via an unspecified route of administration left arm on 14Jan2021 08:15 at single dose for COVID-19 immunization. Medical history was not provided. Concomitant medications included colecalciferol (VITAMIN D) and vitamin b complex. Patient previously took BNT162B2 (lot number: Eu1685) on 23Dec2020 07:45 to Left arm for COVID-19 immunization. On 26Jan2021 Lab data was reported as PCR test, Nasal Swab and Veritor rapid test results were negative. On 15Jan2021 the patient experienced with dysuria, abdominal pain, pelvic pain, bladder spasms, left flank, low back and upper back pain, headache. Patient received Bactrim, Toradol and Advil as treatment for events. Seriousness was reported as non-serious. Outcome of events was unknown. No follow-up attempts are possible. No further information was provided.
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| 63 | 2021-03-30 | nausea |
really bad headache, excruciating headache; nauseous, nausea/queasy; blurred vision; holes in her vi...
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really bad headache, excruciating headache; nauseous, nausea/queasy; blurred vision; holes in her vision; not right; like an allergic reaction; She had soreness in the arm; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of bnt162b2, via an unspecified route of administration, administered in Arm Left on 05Mar2021 16:32 (Lot Number: EN6198; Expiration Date: 30Jun2021) as single dose for covid-19 immunisation. Medical history included allergies to Sulfa drugs, Penicillin, and believes she has allergies to Ploymers (She cannot wear polyester and she has to wear 100% cotton). The patient's concomitant medications were not reported. The patient (at the age of 62-year-old) previously received the second dose of Shingles Vaccine in Jan2021 for immunization. The patient experienced really bad headache, excruciating headache on 09Mar2021 21:00, nauseous, nausea/queasy on 09Mar2021, she had soreness in the arm on 05Mar2021, blurred vision on 09Mar2021, holes in her vision on 09Mar2021, not right on 09Mar2021, like an allergic reaction on 09Mar2021. She developed a "really bad headache" around 9pm on Tuesday 09Mar2021, that caused holes in her vision and pain "straight across my forehead". She did treat with Tylenol and was able to finally sleep around 5am. She states that the headache has persisted, and she's felt "nauseous, queasy, and not right" since the headache started. She is hesitant to get the second dose. She was experiencing headache following. She mentioned she is allergic to sulfa drugs, penicillin, and polymers, and thought maybe the headache was a result of an allergy to the vaccine? Ingredients don't appear to have any of her reported allergens. She had soreness in the arm the first 48 hours, which was to be expected and no big deal for her. However, starting on Tuesday, she had an excruciating headache. She normally does not typically get headaches. She believes in vaccinations and as a teacher the minute she could sign up to get one she did. Now she is terrified to get the second one. When this excruciating headache began she woke her husband up to tell what happened. She thought she was going to die, that is how bad it was and she wanted him to be aware and prepared if anything should happen. The excruciating headache started at 9PM. It was excruciating all night. The headache made her queasy because she hurt so bad. It continued into Wednesday. Today and today the pain is duller in her head, much duller than it was. However, she still feels queasy/nauseous. The headache also started with blurred vision. The blurred vision has gone away. It was like there were holes in the TV. She was thinking it was interesting and did not think much of it at first. She thought one of her contacts had a hole in it, but she did not even have any on. The blurred vision lasted 24 hours. The soreness in arm lasted until Sunday or Monday. She confirmed the pain in arm is gone and was gone by Monday. She initially could not wait to get her shot. Now she is terrified to get the second one. She took Tylenol in the middle of the night on Tuesday and Wednesday for the headache. Has allergies to Sulfa drugs, Penicillin, and believes she has allergies to Ploymers. She cannot wear polyester. She has to wear 100% cotton. She is questioning if the vaccine has polymers in it. From what she heard it does and is wondering if this caused her to have like an allergic reaction. The outcome of the event vaccination site pain was recovered in Mar2021, the events Nauseous and headache was not recovered, other events was unknown.
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| 63 | 2021-03-31 | nausea |
passed out; Unfortunately hit my head.; felt light headed; slightly nauseous; intense right knee pai...
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passed out; Unfortunately hit my head.; felt light headed; slightly nauseous; intense right knee pain; temperature of 99.6; flu-like symptoms; This is a spontaneous report from a contactable Other Health Professional (patient). A 63-year-old non-pregnant female patient received bnt162b2 (Pfizer Brand COVID 19), dose 2 intramuscular, administered in left arm on 26Feb2021 12:00 (Lot Number: EN6198) as single dose for COVID-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient was not diagnosed of Covid prior vaccination and has not been tested for Covid post vaccination. The patient has no known allergies. Concomitant medication included levothyroxine, liothyronine (NP THYROID) taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (Pfizer Brand COVID 19), dose 1 intramuscular, administered in left arm on 05Feb2021 11:30 AM, (Lot Number: EM9810) for COVID-19 immunisation. There was no other vaccine in four weeks. On 27Feb2021 07:45, the patient passed out, unfortunately hit head, felt light headed and slightly nauseous. It was also reported that patient had intense right knee pain, a temperature of 99.6 and flu-like symptoms. The events were also described as follows: 18hrs after the injection, I had intense right knee pain that lasted for 24hrs. Also in that same time period, I felt a huge rush of energy come over me and passed out. Unfortunately hit my head. I had a temperature of 99.6 and flu-like symptoms that lasted 24hrs. For 4 days I felt light headed and slightly nauseous but that could have been due to hitting my head. Called 911, EMT evaluation and the patient received treatment for events. Outcome of the events was recovered on an unspecified date.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events and other events. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified, as appropriate.
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| 63 | 2021-04-01 | abdominal pain |
onset of symptoms of left-sided Bell palsy (twitching, paralysis, lost of taste/sensation of tongue,...
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onset of symptoms of left-sided Bell palsy (twitching, paralysis, lost of taste/sensation of tongue, lid lag etc). I knew I had Bell palsy; Awakened with brief episode (10 min) severe abdominal pain; Severe muscle aches; Head pain; Neck pain; Developed sore on left side of tongue; Neck/mastoid pain; Swollen gland lasted a few days; This is a spontaneous report from a contactable other HCP (patient). A 63-year-old (non pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EN6200, Expiry Date: unknown) via an unspecified route of administration in left arm on 24Feb2021 13:30 at single dose for COVID-19 immunisation. Patient had historical vaccine at 63-year-old BNT162B2, lot number: EL9262 at left arm on 03Feb2021 13:30 at SINGLE DOSE for Covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient's medical history included penicillin and neomycin allergy. Patient's concomitant medications included ergocalciferol (VIT D), rosuvastatin calcium (CRETOR) (medications the patient received within 2 weeks of vaccination). On 25Feb2021, the patient experienced onset of symptoms of left-sided bell palsy (twitching, paralysis, lost of taste/sensation of tongue, lid lag etc). I knew I had bell palsy, awakened with brief episode (10 min) severe abdominal pain, severe muscle aches, head pain, neck pain, developed sore on left side of tongue, neck/mastoid pain, swollen gland lasted a few days. Event was reported as on 25Feb, patient awakened with brief episode (10 min) severe abdominal pain. Later, severe muscle aches, head and neck pain, lasted until following Wednesday (03Mar). Patient developed sore on left side of tongue, neck/mastoid pain, swollen gland; lasted a few days, then noted onset of symptoms of left-sided Bell palsy (twitching, paralysis, lost of taste/sensation of tongue, lid lag etc). By friday 12Mar she knew she had Bell palsy. Medrol dosepak, OTC pain meds was received as treatment for adverse events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The outcome of event was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of Bell's palsy and other events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including Head CT/MRI and viral serology, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 63 | 2021-04-01 | vomiting, diarrhea, nausea |
rash that was all over her body; Extremely red sunburn rash- really bad sunburn, most of it on torso...
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rash that was all over her body; Extremely red sunburn rash- really bad sunburn, most of it on torso, had it on legs/face was so red like the rough sunburn feeling; Eyelids red, itchy, and swollen; Eyelids red, itchy, and swollen; Eyelids red, itchy, and swollen; Felt dizzy and weak/had less energy today; Dizziness and lightheadedness /felt dizzy and weak; Worst and really sharp Charlie horse between ankle and calf- took forever to walk; Extremely dehydrated, kidneys were showing some damage, creatinine level was really off.; Extremely dehydrated, kidneys were showing some damage, creatinine level was really off.; Extremely dehydrated, kidneys were showing some damage, creatinine level was really off.; Anaphylaxis due to vaccination; Vomited; Major diarrhea; She was so cold that her toes were purple; Blood Pressure so low: 58, couldn't find a bottom number at first but then at the hospital it was 58/38; Face was extremely pale; could not function- she was beyond cold; felt like she was in a bad dream and couldn't wake up, couldn't walk. Feeling like she was getting the flu; could not function- she was beyond cold; felt like she was in a bad dream and couldn't wake up, couldn't walk. Feeling like she was getting the flu; could not function- she was beyond cold; felt like she was in a bad dream and couldn't wake up, couldn't walk. Feeling like she was getting the flu; Too cold to function or do anything; Nauseated- almost like morning sickness/Extremely nauseated/queasy feeling; Nauseated- almost like morning sickness; very extremely tired; creatinine /it was still high; sick; body temperature was low; She thought she was going to die because of the purple toes; but it seems like her nose won't stop running ever since she got it, sore from blowing- looks like Rudolph.; but it seems like her nose won't stop running ever since she got it, sore from blowing- looks like Rudolph.; her body catching up on sleep or she's just tired; This is a spontaneous report from a contactable consumer (patient herself). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6206), via an unspecified route of administration, on 11Mar2021 as single dose in left arm for COVID-19 immunisation. Medical history included ongoing High Blood Pressure (It's under control now, fairly healthy; diagnosed probably when she started menopause in early 50s), ongoing Anxiety (Diagnosed probably when she started menopause in early 50s), ongoing Sinus headache (Worst sinuses; Takes Excedrin because Tylenol does not have an effect on her), ongoing smoker (Pack a day, but smoking about only about half of it each time. started when she was a teenager. She was without a cigarette for 3 days in the hospital, but when she came home she had to start again), menopause (in early 50s), shoulder- torn rotator cuff-operated in 2018. Family history included cardiac and heart disease, Parkinson's and Frontal lobe dementia (husband). Concomitant medication included colecalciferol (VITAMIN D3) 1000 IU, once a day, by mouth (Taken these for as long as she can remember, they kept advising it, husband takes it for Parkinson's so she just throws one in for her), calcium ascorbate (VITAMIN C) 1000 IU, once a day, by mouth (Started at least 2 years ago, doesn't drink enough orange juice, doesn't do fruits, doesn't get enough Vitamin C), linum usitatissimum seed oil (FLAXSEED OIL) 1000 IU, once a day, by mouth (Started at least 2 years ago, family history of cardiac and heart disease, takes as preventative) for cardiac and heart disease, takes as preventative, fish oil 1000 IU, once a day, by mouth (Started at least 2 years ago, family history of cardiac and heart disease, takes as preventative) for family history of cardiac and heart disease, takes as preventative, hydrochlorothiazide, lisinopril 20/12.5 mg, once a day, by mouth (She has been taking this medication for years, under control with this medication) for High Blood Pressure, lansoprazole from 2020 30 mg, once a day, by mouth (Started years ago) for Stomach pill for acid reflux, duloxetine hydrochloride 60 mg, once at bedtime, by mouth (Started forever ago) for just being achy and anxiety, lorazepam .05 mg, 1 tablet 3 times a day, takes one tablet a day at bedtime, by mouth for Anxiety (Started this a while back- with the heart disease and everything else, gave this to help with menopause symptoms too), meloxicam 15 mg, at bedtime as needed from 2017 for back issues- really sore at times, takes if really stressed or she overdoes it. Patient previously took Tylenol for sinus headache and does not have an effect on her. After the first dose of the vaccine the patient reported that she was extremely tired on 11Mar2021. She was completely nauseated most of the day on the second day. On Saturday, she was extremely nauseated (12Mar2021) with vomiting and major diarrhea on 13Mar2021. By 4 PM that afternoon (12Mar2021), she could not function because she was so cold; she felt like she was in a really bad dream and couldn't wake up. She called on 13Mar2021, her blood pressure was so low-they got 58 for the top number, they were unable to pull up bottom number at that point. patient reported that when the ambulance arrived, they described her face as extremely pale on 13Mar2021; her major complaint was that she was so cold- she has never been that cold in her life. When she got to the ER- they had to use the old blood pressure cuff to get her blood pressure because it wasn't coming up on the machine- the kind where you pump it up and watch the needle, they said it was 58/38. patient states that they asked her about the rash that was all over her body in 2021; caller reports that she did not have a rash when she called at 4 PM. patient describes the rash as an extremely red sunburn rash- like you got really bad sunburn, most of it was on her torso, she also had it on legs on 13Mar2021. patient mentioned she remembers them taking off sock and her toes were purple on 13Mar2021. She also had a red on her eyelids- she described as itchy and swollen on 13Mar2021. patient mentions that unbelievably as sick as she was in 2021, she could understand everything that they were telling her. Treatment was given as they prescribed her Prednisone and Benadryl; she was also hooked up to an IV, and they were trying to warm up her body because body temperature was low in 2021. Discharge paper reads as anaphylaxis due to vaccination on 13Mar2021. patient states that she came home from hospital on Monday, 15Mar2021. patient reports she started a diet. 2nd day (12Mar2021)- From the time she got up, she was too cold to do anything; she couldn't walk and she was feeling like she was getting the flu. Saturday (13Mar2021)- She woke up and had the worst Charlie horse between ankle and calf- took forever to walk Charlie horse off. Really sharp Charlie horse. Even had less energy today. Really nauseated. patient reports that yesterday and today, she is just tired. She doesn't know if it's just her body catching up on sleep or she's just tired; she will find out today when she goes to doctor. Caller mentions that she is normally more active than she feels right now. patient reports her eyes have been itchy and she has a rash on her eyelids. patient doesn't know if it's from the shot; patient mentions that she decided on 01Mar2021 she would start a diet, get healthy, and see a nutritionist. patient reports that initially she didn't think her symptoms were from the vaccine and thought it was that she wasn't eating enough food on Friday. She got in touch with the dietitian. patient reiterated she did not attribute this to shot right away. patient reports that she was wondering if she had asymptomatic covid, and it would have been within a 3-month period that she reacted to the shot. She was not sick if she did have asymptomatic covid. There still trying to figure out why her body had this reaction. patient states that every now and then she was still cold, but she doesn't know if its her imagination and plus it is cold outside where she is. She is still on the cuff on that one. patient describes the nausea she first felt as almost felt like morning sickness on 12Mar2021-that's why she attributed it to her diet. patient mentions that the day she started feeling better, late Sunday afternoon, she wanted salty foods. Anything salty, chips, she just really wanted salty stuff. She was not normally a salt person, but the saltier it was, the better it was. patient reports that when she was vomiting with diarrhea and laying down, she would be throwing up in a towel because she couldn't make it to the bathroom when she was laying, it would just gush. patient describes it felt like her body was going to be locked into the position it was in, she doesn't know how to describe it. patient states that she had vomit on her clothes when she called. patient reports the nausea stopped late Monday and the queasy feeling went away. patient reports she stopped vomiting when they gave her Zofran- they had to give her a couple because she didn't stop throwing up right away. patient reports she was extremely dehydrated and her kidneys were showing some damage; her creatinine level was really off on 13Mar2021. The diarrhea was gone, but now she has a mixture of soft stools and semi formed. It is trying to improve but hasn't yet. patient states that because of her creatinine level, they did want her to drink and she might have soft stools because she was drinking so much. patient reports she knows when her husband put the shirt on her she did not have the rash, but when the ambulance arrived, they said she had the rash. Upon discharge, they told her not to receive any further covid vaccines- she cannot get her second one which was scheduled for 01Apr2021. She started experiencing the really cold feeling on 12Mar2021 after receiving the vaccine. She went to bed at 7, that's not like her, she was usually up all hours of the night. symptoms she was experiencing were beyond typical. patient reports she also felt dizzy and weak on 13Mar2021. She thought she was going to die because of the purple toes in 2021- she knew that was a sign of her body shutting down and she got the most scared. patient mentions she is experiencing a residual side effect from the covid and influenza tests-both were negative on 13Mar2021, but it seems like her nose won't stop running ever since she got it, sore from blowing- looks like Rudolph in 2021. patient reports she feels human today, but she is still sleepy in 2021. She thinks she would feel a whole lot better if her nose stopped running. The tiredness might be from nose blowing and stuff. patient remembers the nurse was thrilled that her toes weren't purple anymore. It started going away when her blood pressure and everything came back up. patient states that she was so scared that she was dying so she remembers everything that happened. patient remembers she was in the ER still when her blood pressure improved. Treatment for her face was so red like the rough sunburn feeling and putting moisturizer on the dried cheeks. patient reports that she doesn't see any patches of red on her. Part of her has a fear that the stuff is not totally out of her system and it will happen again. patient mentions she has heard comments that this was not a typical reaction from the first one and wants to know if it is typical to be that sick from the first dose. patient reports that now her eyes just feel like she's allergic to something. She doesn't know if the redness is from crying now- it was improving, but was still there. Husband has Parkinson's and Frontal lobe dementia and she is his caregiver, she cannot afford to get Covid, she wants to get back to normal. patient reports that she did not take any of her prescriptions the day of the vaccine, she did not want to get a reaction. patient reports she had her shoulder- torn rotator cuff-operated on in 2018. If nose is really stuffed up or allergies, or Fluticasone nasal spray- she can take it 2 times a day, 2 squirts in each nostril, take it as needed. patient reports that she has the worst sinuses- when it gets too bad, she'll go to the doctor and she'll prescribe Flonase, take Metamucil or whatever she thinks will help with sinuses. she still wants to get the second vaccine. patient reports her creatinine came down well enough that she could come home from the hospital, it was still high on 15Mar2021 so they told her to drink lots of water so she does not get dehydrated. Patient was hospitalized from 13Mar2021 to 15Mar2021 for Anaphylaxis, Tiredness, Nauseated, Morning sickness, Vomited, Activities of daily living impaired, Walking difficulty, Flu like symptoms, Pale, Photosensitive rash, Asthenia, Dizziness, Charley horse, Dehydration, Renal disorder, Creatinine low, Cold, Diarrhea, Purple toes syndrome, Blood pressure low, Redness of eyelid, Eyelids itchy sensation of, Swollen eyelid. For rash also patient was hospitalised. The outcome of Vomited, Pale, Photosensitive rash, Dizziness, Asthenia recovered on 13Mar2021, Nauseated, Morning sickness recovered on 15Mar2021, Activities of daily living impaired, Walking difficulty, Flu like symptoms recovered on 17Mar2021, Diarrhea, Cold, Blood pressure low, Purple toes syndrome, Redness of eyelid, Eyelids itchy sensation of, Swollen eyelid were recovering, Tiredness and Creatinine high were not recovered, while remaining events were unknown. No follow-up attempts are possible. No further information is expected.
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| 63 | 2021-04-09 | decreased appetite |
Chills, fever-diminished sweats-resolved 4/5/2021 migrating erythema, tenderness under erythema, ...
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Chills, fever-diminished sweats-resolved 4/5/2021 migrating erythema, tenderness under erythema, anorexia, bladder irritation-persistent
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| 63 | 2021-04-09 | diarrhea |
pain; flu-like symptoms/felt like she had a little bit of the flu; she has one area with a "big circ...
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pain; flu-like symptoms/felt like she had a little bit of the flu; she has one area with a "big circle around it and it's hard; she had a little bit of pneumonia; got a fever; felt like she couldn't go to the bathroom, cramps; had trouble breathing; the site was red; swelling/her arm is swelling; it does hurt her, right in that area where the shot was given; arm was sore and achy/her arm started aching; Diarrhea; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EN6208, expiration date unknown), via an unspecified route of administration, administered in left arm on 22Mar2021 at the age of 63 years old at a single dose for COVID-19 immunisation. Medical history included ongoing pre diabetic, ongoing high blood pressure, ongoing non-alcoholic liver disease, edema, to help her breathe, pneumonia, COVID in 2021, respiratory problems, asthma, little bit of obesity, swelling in her legs, varicose veins. Concomitant medications included benzonatate at 100 mg to help her breathe, azithromycin (six pills of that, 200mg, two one day and one pill a day until gone) for pneumonia. Patient had her second dose scheduled on 12Apr2021. She explained after the shot, her "arm was sore and achy" she said she also had "pain". She added she experienced "flu-like symptoms". She specified these adverse reactions are all gone now but her arm is still "a little sore" and she has one area with a "big circle around it and it's hard". She said it could be "swelling". She asked if her reaction was reported as side effects to the vaccine. She expressed being in a rush and is expecting her daughter soon and asked us to be quick. She said she will also consult with her HCP this afternoon. Patient stated she had the first shot on Monday 22Mar2021 and today and last night the site was red, but today in that area she has gotten a big circle around it and its hard. Patient stated she's had it before with shots and just wanted to make, sometimes she has had to be put on medicine for it, wanted to be sure its healing because it does hurt her, right in that area where the shot was given. She also stated that after she has her second shot on 12Apr2021, she would like to talk to somebody and she would like to be able to have people in her home. She was reporting she had COVID three weeks ago, would she be ok after the 2nd shot to go out? She stated her daughter thinks she needs to wait until the end of April. She verified she did receive the Pfizer BioNtech Covid 19 vaccine. Swelling: Patient stated her arm is swelling. Also stated she always gets that and today there's a circle there and it is red and hard. Also stated occurred after the shot. Patient reported that the shot hurt like heck and she couldn't really tell, she has big arms, she knows it was swollen. Reported she took over the counter medicines, last night she noticed it was a circle and it was hard there. Stated area is not swelling anymore, now just one hard red circle. Red and a hard circle: She also reporting her entire arm ached after the shot, she stated she knows her entire muscle was aching. Stated it was swollen quite a bit but now its just red and a hard circle, and it's ongoing. Arm swelling outcome: Patient reporting yesterday afternoon, she was feeling better, except that one spot. She stated it does hurt when she bends it because she had that one little area that's swollen. Also stated the swelling started later that afternoon after the shot. Reported she went for a walk with her daughter and her arm started aching. It felt like she couldn't go to the bathroom, cramps. It felt like she had a little bit of the flu, and it was from the shot but it only lasted a few days. Stated that part went fast, got a fever, other than that, just the one area on her arm. Stated she doesn't even feel sick from the shot or anything. Stated she had Diarrhea: Stated she had diarrhea in the beginning after the shot then had trouble going to the bathroom. Stated she thinks its because she has IBS and that's how her body is. She doesn't know if that's from the shot or not because that's how her body always is. Pfizer BioNtech Covid 19 Vaccine: Patient stated she doesn't want COVID again. She has respiratory problems anyway, she has asthma and a little bit of obesity. She states she was in fear of herself. She doesn't do well with hospitals and being put under with that medicine. Also stated patient knew COVID causes a lot of people having trouble breathing and she doesn't want to end up on a breathing tube where its breathing for her and she never sees her family again. Caller states it kind of scared her. Patient stated her niece and nephew, whos got it worse. She stated she went to the hospital and haven't been back. She stated she was hospitalized about 2 weeks ago, and that's when she was diagnosed with COVID, before she got the first COVID shot. About the medical history, non-alcoholic liver disease: Stated diagnosed about eight years ago, she would say the same time, about 7 to 8 years ago because she had a virus and when she went in the hospital, the virus had attacked her right kidney and liver. She stated with non-alcoholic liver disease, she is overweight, and that causes her to have issues with her liver. The last few times her liver has been okay. Pre-Diabetic: They have been watching that for a while. Stated she gets edema, swelling in her legs, well, all the time. She has had this the last two years because she is pre-diabetic and a lot of overweight people have that. She also has varicose veins so that doesn't help. Stated that was given those to help break up, because she had pneumonia when she got the COVID and she had a little bit of pneumonia and had trouble breathing. The patient was recovering from arm was sore and achy/her arm started aching, swelling/her arm is swelling and for other events it was recovering.
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| 63 | 2021-04-09 | blood in stool |
arm started swell a little bit; woke me up at 5 O'clock this morning in pain; arm started swell a li...
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arm started swell a little bit; woke me up at 5 O'clock this morning in pain; arm started swell a little bit; woke me up at 5 O'clock this morning in pain; shoulder is kind of swollen; shoulder is kind of swollen, it's got big old knot and it's red and it's apparent itchy; shoulder is kind of swollen, it's got big old knot and it's red and it's apparent itchy; shoulder is kind of swollen, it's got big old knot and it's red and it's apparent itchy; arm kind of still stiff and sore; Blood in stool; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER2613 and expiration date not provided) via an unspecified route of administration administered in the arm, on 23Mar2021 as a single dose for COVID-19 immunization. Medical history included breast cancer survivor. The patient's concomitant medications were not reported. The patient stated that she was trying to figure out what to do. On 26Mar2021, her arm started to swell a little bit. When she woke up, it woke her up at 5 o'clock in pain and her shoulder was kind of swollen, it has got big old knot and it was red and it was apparent itchy and she could not scratch it so, she thought about it and she got an ice pack, so she put ice on it. She was holding ice on it now, trying to sooth it. She was wondering where she would go for reaction, she knew she had reaction like this before so she had a side effect from it, and her arm was kind of still stiff and sore. She did not go to the emergency or urgent care because she looked at left and she looked at the right and like she said, it was swollen and she got big old knot and it was red. She also stated that she did not take Tylenol today. She did not know what she wanted to get through to somebody and she needed to speak to somebody on what she needed to do. She also said that on an unspecified date in Mar2021, in her stool, she found some blood. She had another appointment with her "thyroid" (not clarified) and she does not know the results yet. The outcome of the events was not recovered. Information about lot/batch number has been requested.
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| 63 | 2021-04-09 | vomiting, abdominal pain lower, abdominal pain upper, diarrhea |
sick; exhausted/wiped out; stomach kind of hurts; started to feel lousy; tiny bit of dizziness; Weak...
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sick; exhausted/wiped out; stomach kind of hurts; started to feel lousy; tiny bit of dizziness; Weakness; lower abdomen hurt; tired; vomiting; diarrhea; sweaty; little bit of rectal bleeding after diarrhea; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine), dose 1 via an unspecified route of administration, administered in Left upper arm on 24Mar2021 (Batch/Lot number was not reported; Time the Vaccination Was Given was around 15:30) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing thyroid, renal disorder from an unknown date and unknown if ongoing , diabetes from an unknown date and unknown if ongoing, blood pressure measurement from an unknown date and unknown if ongoing, vaginal disorder from an unknown date and unknown if ongoing, colitis from an unknown date and unknown if ongoing. Reported following prior vaccinations was stated she had a sore arm sometimes with the flu shot and felt kind of sick but not always. Concomitant medications included levothyroxine (LEVOTHYROXINE) taken for thyroid from an unspecified start date and ongoing (reported she started taking this decades ago); metformin (METFORMIN) taken for diabetes from an unspecified start date and ongoing ((reported she started taking this decades ago); lisinopril (LISINOPRIL) to protect kidneys with diabetes and for blood pressure, started years ago and took a small dose, stated her blood pressure was usually fine; estradiol (ESTRACE) taken for when the vaginal tissues get disintegrated from an unspecified start date and ongoing (stated she started this a very long time ago). The patient experienced little bit of rectal bleeding after diarrhea on 25Mar2021 with outcome of unknown, sick on an unspecified date with outcome of unknown, tired on 25Mar2021 with outcome of not recovered, vomiting on 25Mar2021 with outcome of unknown, diarrhea on 25Mar2021 with outcome of unknown, sweaty on 25Mar2021 with outcome of unknown, exhausted/wiped out on an unspecified date with outcome of unknown, stomach kind of hurts on 25Mar2021 with outcome of unknown, started to feel lousy on 25Mar2021 with outcome of unknown, tiny bit of dizziness on 25Mar2021 with outcome of not recovered, weakness on 25Mar2021 with outcome of unknown, lower abdomen hurt on 25Mar2021 with outcome of unknown. The event little bit of rectal bleeding after diarrhea considered serious as medically significant. The AEs not require a visit to Emergency Room or Physician Office. Received the first dose of the Pfizer Covid 19 vaccine Wednesday afternoon, yesterday, patient felt okay, but was off, got really sick in the middle of the night. during the day , tired, expected that, but at night vomiting, diarrhea and weak, sweaty, kind of bad. it stopped today she was just exhausted and her stomach kind of hurts. She was better than last night, today she was just more worn out by this, she took a Imodium. She had the vaccine Thursday afternoon and yesterday she felt lousy, nothing severe and last night she was very sick. Stated she was still trying to get better today. Stated she called and left a message with the FDA/CDC vaccine adverse event reporting system a little while ago. Caller clarifies she got the vaccine on Wednesday 24Mar2021 and that she started to feel a little lousy 25Mar2021, more like the symptoms that are described, she was tired and had a tiny bit of dizziness that came and went, it was mostly tired. Stated in the middle of the day she laid down for an hour and that was around lunch time. Stated the dizziness was off and on like when she was driving and just here and there. Stated the tired was still persisting. She stated she did not have NDC, lot, expiry date or dose to provide. Stated she see EUA on the sheet but not much else. Stated it was the 1st dose. Stated she forgot to tell about last night. Stated she woke up around midnight very sick with vomiting and had diarrhea and was sweaty. Stated her stomach hurt and her lower abdomen hurt. Stated she was not sure if these are from the vaccine or a coincidence. Stated she had stopped throwing up, just did that a few times. Stated the diarrhea stopped after a little while. Stated she still has abdominal pain today and weakness was with the diarrhea and she would lay down in bed. Stated she was still a little weak, that she was more wiped out and tired. Caller stated she was bleeding a little bit after the diarrhea and it scared her because a couple years ago she had colitis and it scared her, that she called a relative who is a retired nurse and she thought it was from the diarrhea. Caller clarified she contacted her relative about this current event with the bleeding. Caller provided that she took Imodium this morning and has been sipping on water and had a little breakfast, she thought she may be a little dehydrated. Patient stated her symptoms were pretty bad last night, it was acute. Patient clarified that it was rectal bleeding and it was just a little this morning. Stated it happened last night and again this morning. Stated she was not sure if it was still occurring and hopes it stopped as it it's scary. Stated today she was just resting and trying to get better. Patient said that if it gets worse she will call her doctor and that she had called the hospital last night and they didn't have anything to say. Stated that if it was from the vaccine she was hoping that it's very temporary and went away and be gone if it was from the vaccine. Patient was asking if there was information about the chance that this was related to the vaccine, stated they were not listed as possible side effects. Stated she had people from the hospital and relatives she has talked to that say it may be. Information on the lot/batch number has been requested
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| 63 | 2021-04-11 | nausea | Severe headache, nausea, weakness, fever and chills. Only headache remains 2 days later. |
| 63 | 2021-04-11 | vomiting |
12 hours after receiving 2nd vaccine (4-5-21) I started throwing up through Tuesday 4-6-21. Then on...
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12 hours after receiving 2nd vaccine (4-5-21) I started throwing up through Tuesday 4-6-21. Then on 4-7-21, my left leg calf was very sore and hard for me to walk, Got worse, so on 4-9-21 went into Urgent care and through a vascular ultra sound determined I had a very Large blood clot in my calf. (ACUTE THROMBOSIS OF THE LEFT PROXIMAL PERONEAL VEIN)
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| 63 | 2021-04-13 | abdominal pain, appendicitis |
Initial mild fatigue day 2 & 3 followed by abdominal pain day 3. Accute Appendicitis, followed by s...
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Initial mild fatigue day 2 & 3 followed by abdominal pain day 3. Accute Appendicitis, followed by surgery to remove appendix
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| 63 | 2021-04-14 | nausea |
Chills and fever (~101.0F) at initial onset which lasted approximately 8 hours. Fatigue which laste...
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Chills and fever (~101.0F) at initial onset which lasted approximately 8 hours. Fatigue which lasted ~24 hours. Nausea which lasted ~8 hours. All resolved 48 hours after injection.
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| 63 | 2021-04-18 | nausea, diarrhea |
Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third...
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Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; This is a spontaneous report from a non-contactable consumer (Patient). A 63-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8732), dose 1st via an unspecified route of administration, administered in Arm Left on 01Apr2021 08:00 as single dose for covid-19 immunisation. Patient medical history and concomitant medications were not reported. On 01Apr2021 11:15, the patient experienced Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack. The patient had other medications in two weeks of vaccination. Patient did not took any treatment for adverse event. Patient did not had covid prior vaccination and not tested for covid post vaccination. She did not have any Known allergies and had other medical history. No follow up needed. No further information is excepted.
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| 63 | 2021-04-24 | nausea, vomiting, difficulty swallowing, diarrhea |
Also felt that she almost faint, not dizzy not vertigo type for under a minute; stroke; meningitis; ...
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Also felt that she almost faint, not dizzy not vertigo type for under a minute; stroke; meningitis; have massive diarrhea; had a sore throat and could not swallow or eat; menstrual cramps; felt alot of extreme fatigue; felt hands to be freezing for 4-5 days and she have to get hot water to wrap around it; sinus pain; her face and eyebrows hurt; throw up viscously that it is almost coming out of her nose and also went to sheer panic/vomiting; she is not speaking well or understood well; profusely sweating and had whole body sweat drenched on the floor; ice-cold ends; painful arm; baseline temperature is 94.6; Neck pain; Woke up Monday morning and couldn't get out of bed, wanted to die; Caller states she is losing her mind; had her gripping her pelvis because of the pain; sheer panic.; woke up with gut ripping food poisoning; still very tired; couldn't get out of bed; had a sore throat and could not swallow or eat; feel nauseous; feeling dehydrated; her head because of the ache; getting sick; nausea; experienced severe headache which led her to stay in bed all afternoon/her headache is more severe and describe it as she would like to shot her head because of the ache; has a flu-like chills; body ache symptom which comes and go; This is a spontaneous report from a contactable consumer. A 63-years-old female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534) via an unspecified route of administration in arm left on 21Mar2021 as single dose for covid-19 immunisation. Medical history included taking a anti-HTN medicine (beta blocker) and had slowly been weaned off of that prior to getting his shot as her cardiologist is afraid that it might affect the efficacy of the vaccine shot and had not been put back in any BP regulating meds until then and quite concerned because of her fluctuation BP. anxiety and gets to panic immediately, also is disabled and doesn't live with any nearby family, has allergies to alot of foods. State she comes from family of strokes, heart attacks, and high blood pressure and one of her biggest fears is having a stroke. States her boyfriend has a family of strokes too, 2 blood pressure medicines, which contain polyethylene glycol (PEG). and concomitant medications not reported. The patient stated after 1 week of getting the vaccine- getting sick, felt alot of extreme fatigue, felt hands to be freezing for 4-5 days and she have to get hot water to wrap around it. On 03Apr2021 experienced severe headache which led her to stay in bed all afternoon, she also has a flu-like chills body ache symptom which comes and go. On 04Apr2021 experienced nausea and took Tylenol for feeling so sick and felt well 2 hrs after. On 05Apr2021 woke up feeling all the symptoms like the other days, her headache is more severe and describe it as she would like to shot her head because of the ache, she also had a sore throat and could not swallow or eat for 2 1/2 days, she also feel nauseous and throws up water already, she already was feeling dehydrated. After which she called her doctor and mentioned that no organization or her doctor cant guide her well with regards the symptoms that she is feeling if this is common after receiving the vaccine. She asked her doctor and her doctor said that it could probably be a symptom of COVID19 infection. So she got tested and turned out she had a negative result. After a while she also experienced some sinus pain that was not normal for her, she also mentioned that her face and eyebrows hurt. She went to her ENT and ENT who she trusted and respected a lot as a surgeon because according to her is very well versed mentioned that these are not normal side effects that she is experiencing. She also consulted with a brain surgeon and the brain surgeon mentioned that if the side effects won't go away , advised that she need to go to an ER and that doctor feared that he could be having stroke or meningitis. In shock, patient called her cardiologist again and cardiologist advised her not to be alarmed about brain surgeon's advised. She was back to her BP management medication for 2 days already and cardio advised that she should get the vaccine still. On Wednesday and Thursday- her sinus pain went away she had experienced the worst pain ever and had her gripping her pelvis because of the pain, she also have massive diarrhea, had nausea and throw up viscously that it is almost coming out of her nose and also went to sheer panic. Also felt that she almost faint, not dizzy not vertigo type for under a minute. Called her neighbor and neighbor said that she is not speaking well or understood well. She was profusely sweating and had whole body sweat drenched on the floor. Called her physician and physician said that it could be food poisoning. Patient even said that she is not blaming the above event with Pfizer. Also mentioned she experienced sore throat in between. Patient states she is losing her mind, she is a highly anxious and panicky person, she was worried about getting the vaccine at first, but went ahead with it. States she has removed herself from her blood pressure medication, Bystolic, because there is an ingredient in there that is a beta blocker, polyethylene glycol or polysorbate or something. Worried of having an anaphylactic reaction now after the vaccine to the medication, states she has allergies to alot of foods. Patient states she had a very painful arm at first, that she had no symptoms for the first four days, states a week later she started getting sick, states last Saturday symptoms worsened significantly, that she had a headache and it wouldn't go away for 4-5 days, nausea, vomiting a couple of days, dehydration, a little diarrhea, chills, mild body aches. One day she was down for the count, then on Easter Sunday she took a Tylenol and was better. Later in the afternoon the nausea came back. Woke up Monday morning and couldn't get out of bed, wanted to die. States her baseline temperature is 94.6 and she went all the way up to 98 it was rising, body aches, sore throat. Went and got tested for Covid, flu, and strep and were all negative at urgent care. There the doctor told her because of her neck pain that she says she has had for years, she could die of a stroke or meningitis and so she called her ENT and they told her to wait a couple days and then to go to the emergency room if she was not better and the headache does not go away soon. patient states she does feel better today, only last night she woke up with gut ripping food poisoning, like she had the flu, Had worst menstrual cramps in that area, then she was throwing up, had diarrhea, felt like she was going to faint, went into this ungodly sweat. Saw on news that more people are getting sick a week or more after the shot, did not mention which shot they received. States she has a previous disability and a broken foot. Today she is feeling fine, just still very tired. experienced side effects between 1-1.5 weeks after the injection. She listed the following symptoms: headaches, chills, nausea, a sore throat, fatigue, ice-cold ends, vomiting, and diarrhea. She specified her sore throat was from hell, her temperature was up, but she had no fever, and both the vomiting and diarrhea were little. She added last Saturday was when she felt sick the most and it lasted 4-5 days. She said she tested for COVID-19 and the Flu. She specified the doctors also thought she had a stroke then meningitis. She explained she spoke with 3 doctors but feels like she's on her own to determine whether she should get the second dose. The patient underwent lab tests and procedures which included body temperature: up, body temperature: 94.6, body temperature: 98, influenza: negative, sars-cov-2 test: negative, streptococcus test: negative. Seriousness was non-serious. The outcome of the events was unknown.
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| 63 | 2021-04-26 | nausea |
Vertigo; nausea; headache; swollen glands; fatigue; This is a spontaneous report received from a con...
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Vertigo; nausea; headache; swollen glands; fatigue; This is a spontaneous report received from a contactable consumer (patient). A 63-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EP7534) via an unspecified route of administration on 21Mar2021 at 14:30 (at the age of 63-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included high cholesterol and allergic to plants and pollen. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included simvastatin, thyroid (ARMOUR THYROID), progesterone, and estradiol from unknown dates for unknown indications. The patient previously received oxycodone hydrochloride, paracetamol (PERCOCET) and montelukast (SINGULAIR) from unknown dates and experienced allergy. On 22Mar2021 at 16:45 the patient experienced vertigo, nausea, headache, swollen glands, and fatigue. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of vertigo, nausea, headache, swollen glands, and fatigue were recovered. It was also reported that since the vaccine, the patient had not been tested for COVID-19. No follow up attempts are needed. No further information is expected.
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| 63 | 2021-04-27 | difficulty swallowing |
her throat got swollen; burning sensation at the site; tiredness; achiness all over; her throat got ...
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her throat got swollen; burning sensation at the site; tiredness; achiness all over; her throat got red; could not sallow; her lymph nodes in the neck were swollen, they hurt really bad; Her lymph nodes in the neck were swollen, they hurt really bad; had pressure in the ears; ain in the shoulder, back of the head, in the back and in the neck; ain in the shoulder, back of the head, in the back and in the neck; ain in the shoulder, back of the head, in the back and in the neck; ain in the shoulder, back of the head, in the back and in the neck; This is a spontaneous report received from contactable consumer (patient). A 63-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 27Mar2021 (Batch/Lot number was not reported) as single dose (at the age of 63-year-old) for covid-19 immunisation. Medical history included COVID-19, she was tested positive for COVID in Jan2021. The patient's concomitant medications were not reported. On an unspecified date she experienced burning sensation at the site (that went away), later experienced tiredness, achiness all over, and her throat got red and swollen, could not sallow, she felt like getting COVID again after the vaccine. Her lymph nodes in the neck were swollen, they hurt really bad, had pressure in the ears, pain in the shoulder, back of the head, in the back and in the neck. She wanted to know if she should to get the second dose or not, if she can get the shot in the gluteal or other sites. The event her throat got swollen was considered medically significant. The outcome of Vaccination site burning was recovered, of all other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 63 | 2021-04-30 | nausea, diarrhea |
Chills; Fever; Muscle soreness; Diarrhea; Nausea; I still have it and I tried to eat, if I eat anyth...
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Chills; Fever; Muscle soreness; Diarrhea; Nausea; I still have it and I tried to eat, if I eat anything normal I just , it didn't works and I take OTC but it's not getting better and I never had this in my life; I kept thinking everyday will get better and it's just haven't; Anatomical site of administration-The consumer stated, "On my shoulder, left shoulder."; This is a spontaneous report from a contactable consumer (patient). This 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left shoulder on 26Feb2021 (Lot Number: EL3247) as single dose (at 63 years old) for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included curcuma longa (TURMERIC [CURCUMA LONGA]), colecalciferol (VITAMIN D 3). Previously the patient received the first dose of BNT162B2 (Lot Number: EM9810) on 05Feb2021 in the left shoulder for COVID-19 immunisation. On an unspecified date (as reported), the patient experienced chills, fever, muscle soreness, diarrhea, nausea, I still have it and I tried to eat, if I eat anything normal I just , it didn't works and I take OTC but it's not getting better and I never had this in my life, I kept thinking everyday will get better and it's just haven't. Therapeutic measures were taken as a result of diarrhea included antidiarrheal. The outcome of the events was unknown (as reported). The consumer stated, "I had my Pfizer second shot on 26Feb2021 and I had chills and the fever and sore muscles and about four days later I started having Diarrhea, nausea and I had it the entire month and I still have it and I tried to eat, if I eat anything normal I just , it didn't works and I take OTC but it's not getting better and I never had this in my life". Anatomical site of administration, the consumer stated, "on my shoulder, left shoulder". No follow-up attempts are needed. No further information is expected.
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| 63 | 2021-04-30 | nausea |
she was dying from the first shot; Nausea; right arm got sore; Migraine headache; got chills shaking...
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she was dying from the first shot; Nausea; right arm got sore; Migraine headache; got chills shaking bad; got chills shaking bad; muscle aches, even in her fingers; Feet being Ice cold; no energy; dizzy; This is a spontaneous report from a contactable consumer(patient). A 63-year-old female patient received the first dose of BNT162B2 (Lot Number: ER8737, expiration date: 31Jul2021), via an unspecified route of administration in right arm on 13Apr2021(between 10:15 and 10:30) at single dose for covid-19 immunisation. The patient's medical history included COVID in 2020(had the COVID virus about a week and a half before Christmas/had COVID in the past). Concomitant medications included two unspecified medications. No other vaccines were received within 4 weeks prior to the COVID vaccine. The patient was calling about the Pfizer COVID shot. The patient stated she received her 1st shot on Tuesday(13Apr2021) and she didn't know if you have had the COVID virus you weren't suppose to take the shot. She stated that she had the COVID virus about a week and a half before Christmas. The patient stated that she went through a vaccine drive thru and after she got the shot, by time she drove around the corner to park her car, she was dizzy. The patient stated that around 8 o'clock Tuesday night, her right arm was so sore, she stated that she got the shot in her right arm because she uses that arm more. The patient stated her arm got real sore, she had a migraine headache, she got chills and was shaking so bad on 13Apr2021. She had never had chills like that before. Her muscles were aching real bad, it was aching even in her fingers, they were hurting on 13Apr2021. The patient stated that the bottoms of her feet were ice cold on 13Apr2021. She had nausea on an unknown date. She stated that she had the same symptoms as when she had COVID, except the lack of taste and smell. The patient stated that she has no energy on 13Apr2021. She says now, she is afraid to get the second shot because she hears it is worse than the first shot. She stated that still today, she has no energy what so ever. The patient stated she thought she was dying from the first shot on an unknown date. She was scared to take the second one. The patient confirmed she got her 1st dose on 13Apr2021. The patient stated the dizziness started 5 minutes after getting the shot. She said she didn't pay much attention to when it stopped but it was probably later on in the afternoon. The patient said that the dizziness was really noticeable when she was sitting in the car. The patient said her arm is still sore. She said that it is not as sore. She said that on Tuesday it hurt to move her arm but now it is just sore to the touch. The patient stated that her headache, last night started easing off and she woke up this morning and it was gone. The patient stated that the chills and shaking are much better but she still gets cold and then she gets warm and then cold again. The patient stated she took Aleve because her head, and it was easing up before she went to bed, she took Aleve for the pain and headache and she woke up and it was gone. She stated that she is a little better but still doesn't have a lot of energy. The patient stated she was on two medications but it's not for COVID. The patient stated the facility gave her paper work, and she filled out the paper work and she told them that she had COVID in the past on the paper work. No Emergency Room or Physician Office visit was required for the events. The outcome of the events "she was dying from the first shot" and "Nausea" was unknown, of the event " dizzy" was recovered on 13Apr2021, of the event " Migraine headache" was recovered on 15Apr2021, of the event " muscle aches, even in her fingers" and "Feet being Ice cold" was recovered on 14Apr2021, of the other events was recovering.
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| 63 | 2021-04-30 | vomiting, flatulence, nausea, decreased appetite, abdominal pain |
stomach abdominal cramping; Appetite decreased; like gassiness; back pain; she was so sick.; she has...
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stomach abdominal cramping; Appetite decreased; like gassiness; back pain; she was so sick.; she has a rash about the size of a quarter at the injection site; temperature of 102 degrees/fever; tightness in her chest; She threw up five times; She felt nauseous; Nightmares; She started coughing; muscle weakness; Her arm is sore; She could barley lift her arms; very very weak; delirious; restless; her head was pounding; has been sleeping an enormous amount.; headache; restless; This is a spontaneous report from a contactable consumer. A 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm right on 12Apr2021 15:00 (Lot Number: EW0153) as single dose for COVID-19 immunisation. Medical history included Neuropathy, Blood pressure abnormal, and allergic to cats, dogs, and everything outside. Concomitant medications included clonazepam taken for neuropathy peripheral, start and stop date were not reported; captopril taken for blood pressure abnormal, start and stop date were not reported; cyanocobalamin (VITAMIN B12) taken for an unspecified indication, start and stop date were not reported. The patient previously took the first dose of BNT162B2 on 23Mar2021 15:40 (Lot number: EH6204, She has difficulty reading the handwriting, she stated that the second character H, may not be an H.) (at age of 63-year-old) in right arm for Covid-19 immunisation and she felt like she got hit by mac truck, she was that tired and She felt like she could hardly move. There was no additional vaccines administered on same date of the Pfizer suspect or prior vaccinations (within 4 weeks). On the weeks that she received the first and second dose of her COVID vaccine, she skipped getting her allergy shot that week. She normally got her allergy shots every week. Patient weight: 176-178 pounds. It was reported that the patient was fine after she received the second dose, until about 11:00PM on 12Apr2021. She started to get muscle weakness. She was delirious on Monday night (12Apr2021). She also felt restless on 12Apr2021. Her head was pounding on 12Apr2021. She felt nauseous on 13Apr2021, very very weak began on 12Apr2021 23:00 and had tightness in her chest on 13Apr2021. She has only thrown up three times in 50 years. She threw up five times on Tuesday, 13Apr2021. She started coughing Tuesday morning, 13Apr2021. She thought maybe she was coughing because she needed to throw up. She does not know why she is coughing. Over the past few days, she has stayed in her pajamas so she did not look for a rash. She noticed she has a rash about the size of a quarter at the injection site. She did not really pay the rash much attention since she was so sick. She has a rash about the size of a quarter at the injection site, She noticed it on 14Apr2021 whenever she took a shower and took of the band aid. Clarified that it is about the size of a silver dollar. There was also a knot. She began running a fever on 13Apr2021. Yesterday (14Apr2021), she had a fever of 102 degrees. She has been taking 2,000-3,000mg of Tylenol and it has not been helping her fever. Yesterday (14Apr2021), her temperature was the same, and her head was pounding. She was able to eat a little bit, she drank a lot. She has been sleeping an enormous amount from 12Apr2021. Last night (14Apr2021) her temperature was at 100 degrees. It started to come down, before she got up. She normally does not sleep eight hours a night. She has been sleeping more than eight hours. Before she got up out of bed this morning (15Apr2021), she checked her temperature and it was 98.6 degrees. She knows that most people do not consider that a fever, but for her that is. Her temperature is usually 97 something degrees. 98.6 degrees is still sick to her. She was going to work from home today (15Apr2021), but whenever she sat at the keyboard to type, she could barley lift her arms. She could barley lift her arms began about 11:00PM on 12Apr2021. She has not tried to work. She still has a bit of a headache, and her fever broke, so she thought she could work today (15Apr2021). She felt extremely weak. Her stomach was cramping. She drank some tea, and ate a banana. She would describe it as stomach abdominal cramping. She was not expecting to feel this way. Her arm was still sore. Her arm was sore began about 11:00PM on 12Apr2021. She was going to see her doctor next week for a semi annual check up appointment.She was restless all day yesterday (14Apr2021). She has a back back, and has back pain. Whenever she has muscle weakness, her back is bad, and makes her hurt every where. Yesterday (14Apr2021), she was still restless and could not sit still. It is better today (15Apr2021), but has not gone away. On the morning of 13Apr2021, she felt nauseous. Now she feels a different type of nauseous. Before the nausea was in her chest, she thought she was going to have a heart at-tack. She called her husband at work, and asked him to come home because she was so scared. Whenever she threw up, it relived the pressure in her chest. She vomited four times and it gave her immediate relief. She vomited one more time later that evening after trying to eat some chicken broth. She just drank liquids after that. Nauseous intestinal: It feels more intense today (15Apr2021). It feels like it is moving down. Clarified that this is the same feeling as stomach abdominal cramping. She has issues with IBS, and diver-ticulitis. But this is different. She has not eating anything. With IBS, it is eating and the diarrhea. This is more like gassiness. She has had bowel movements, they are more intense with abdominal con-tractions. Very weak: Began about 11:00PM on 12Apr2021. She knew that night that she was not going to be able to go to work the next day. It is better. She thought that is was resolved this morning (15Apr2021), but then she could not get up the stairs. Her office is upstairs. Whenever she got to her office, she lifted her her arms to type and it was hard for her to hold her arms up. She has been sleeping an enormous amount: She did not do anything but drink, use the bathroom and sleep on 13Apr2021. Whenever she was sleeping, it was not a good sleep. Her temperature was 102 degrees, and her head was pounding. She was having nightmares. She was in a constant state of dreaming that she could not get out of. She still has been sleeping a lot. She has been trying to walk around. She put on a lidocaine patch, and is wearing a back brace. She was sleeping less than she was but it is still an enormous amount for her. She normally sleeps about five to six hours a night. The events did not result in emergency room visit or physician office visit. Therapeutic measures were taken. The outcome of events muscle weakness, restless, 'Her head was pounding', Weakness, cough, was recovering, of delirious was recovered on 14Apr2021, of 'tightness in her chest' was recovered on 13Apr2021, of nightmares was recovered on 14Apr2021, of other event was unknown.
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| 63 | 2021-05-04 | nausea, diarrhea |
she actually feels like she has covid; she actually feels like she has covid; felt like her head was...
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she actually feels like she has covid; she actually feels like she has covid; felt like her head was in a tunnel/surround sound in her head; she was scared to death; ringing in her ears; diarrhea; nausea; ear aches that make it feel like her hearing is off; the vaccine may have poked her in the bone; temperature and it has been pretty normal for the most part and went up to 99.9 degrees Fahrenheit; felt like I wished I were dead; sick; tired; This is a spontaneous report from a contactable consumer (the patient). A 63-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN5318; Expiration Date: 2021), via an unspecified route of administration, on 09Apr2021 at 14:30 (at the age of 63-years-old) as a single dose in the right arm for COVID-19 immunization. The patient's medical history was not reported. Historical vaccinations included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EP69556121) on 18Mar2021 (at the age of 63-years-old) as a single dose in the right arm for COVID-19 immunization. There were no concomitant medications. The reporter state that exactly seven (7) days after her second dose, she "felt like I wished I were dead." She reports having diarrhea and nausea that she is still struggling with, and also reports ear aches that make it feel like her hearing is off, describing it as an echo "like I'm in a tunnel or buried in the sand." She reports that this "head thing" was so severe in the beginning and reports that it is still ongoing. She states she couldn't even stand to hear the television and reports that it felt like there was a "surround sound" in her head. She also reports that she just wanted to lay in bed one afternoon and when she woke up the next morning, she was still tired. She reports now that she is progressively feeling "some better" and thinks in 3 days that it will be gone, but she also believes that she may have COVID-19 now and feels like the 2nd Pfizer Vaccine actually bred the disease in her for some reason and she wished she was dead for three days. She also stated that she has spoken with her HCP about this who suggested she visit an urgent care; however, the caller states she cannot drive and has no means of transportation to this appointment. She continued to say that the symptoms were horrible and she is still going through it; states last night she was scared to death and she does not drive or she would have taken herself to the emergency room. She stated that she still had the ear ache, it is not so "echoey" but she still hears some of the ringing in her ears. The other thing concerning happened yesterday - she has also been monitoring her temperature and it has been pretty normal for the most part and went up to 99.9 degrees Fahrenheit and she has been trying to get ahold of someone to report this. States last night was the worst night with diarrhea and she was up and down all night long. The patient also mentioned that her second dose of the Pfizer Vaccine was in her right arm and the woman who gave her the vaccine may have poked her in the bone and caused her to jump. The patient experienced that she actually feels like she has COVID on an unspecified date with outcome of unknown, felt like "I wished I were dead" in Apr2021 with outcome of unknown, the vaccine may have poked her in the bone on 09Apr2021 with outcome of unknown, diarrhea on 16Apr2021 with outcome of not recovered, ear aches that make it feel like her hearing is off on 16Apr2021 with outcome of not recovered, tired in Apr2021 with outcome of recovering, felt like her head was in a tunnel/surround sound in her head on 16Apr2021 with outcome of recovering, nausea on 16Apr2021 with outcome of not recovered, she was scared to death on 16Apr2021 with outcome of not recovered, ringing in her ears on 16Apr2021 with outcome of unknown , temperature and it has been pretty normal for the most part and went up to 99.9 degrees fahrenheit in Apr2021 with outcome of unknown and sick in Apr2021 with outcome of unknown. The patient underwent lab tests and procedures which included body temperature: 99.9 degrees Fahrenheit on Apr2021.
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| 63 | 2021-05-07 | nausea |
DVT; tingling feeling on my right leg; leg was severely black and blue/black and blue on my right sh...
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DVT; tingling feeling on my right leg; leg was severely black and blue/black and blue on my right shoulder; very warm; swelling rapidly; sever left arm pain; nausea; Floating Bruising; Charlie horses on right leg calf; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 20Jan2021 (Batch/Lot Number: EL 3249) as SINGLE DOSE for covid-19 immunisation, at 63 years old. Medical history included caesarean section from 1988, and allergy to animal (Cat and Dog dander) from an unknown date. Patient received the first dose of BNT162B2 via an unspecified route of administration, administered in Arm Left on 30Dec2020 17:00 (Batch/Lot Number: EK9231) as SINGLE DOSE for covid-19 immunisation. There were no concomitant medications. The patient previously took tramadol and experienced drug hypersensitivity (allergies). On 08Apr2021, while patient was reclining in her chair, she felt a tingling feeling on her right leg. She pulled up her pants leg and found her leg was severely black and blue, very warm and swelling rapidly. She went to the ER they did a CT scan and Chest Xray (Apr2021). The ER Doctors (mostly Medical Students at a Teaching Hospital) suspected she had a DVT. Patient was also experiencing severe left arm pain, left hand tingling and severe nausea. They said patient was fine on all accounts and told to get rays of her right leg and for her to follow up with her primary Doctor who is an NP with Hospital. After doing everything as instructed by all the Physicians, 16 days of the bruising and ER visit, patient is still experiencing "Floating Bruising" appearing on her right leg, right ankles and Charlie horses on right leg calf. Today patient now have black and blue on her right shoulder. Patient commented "Someone help me please. This is scary". Events occurred on 08Apr2021 17:00. Treatment was received for the events and required emergency room and physician office visit. Outcome of the events was not recovered.
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| 63 | 2021-05-11 | blood in stool |
Platelet count of 4, bleeding (nose, urine. stool), petechiae & bruising over body. Patient given p...
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Platelet count of 4, bleeding (nose, urine. stool), petechiae & bruising over body. Patient given platelet transfusion, high dose dexamethasone and IVIG. Platelet count rose to 29. Discharged and follow-up with hematology
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| 64 | 2021-01-01 | decreased appetite | Body aches, fever less than 101, headache, nausea, lymphadenopathy, fatigue ,loss of appetite |
| 64 | 2021-01-03 | vomiting |
LATE EVENING OF 12/30/20 DEVELOPED FEVER, CHILLS, VOMITING, BODY ACHES, AND FATIGUE. LASTED 3 DAYS. ...
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LATE EVENING OF 12/30/20 DEVELOPED FEVER, CHILLS, VOMITING, BODY ACHES, AND FATIGUE. LASTED 3 DAYS. IS NOW RESOLVED.
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| 64 | 2021-01-04 | diarrhea |
Vaccine given on 12/17/20 went to ER on 12/18/20 . Started having diarrhea at 4am on 12/18/2020. Cam...
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Vaccine given on 12/17/20 went to ER on 12/18/20 . Started having diarrhea at 4am on 12/18/2020. Came in to work and felt short of breath and heart rate increased. She went to the ER. She was given a liter of fluid 0.9% NACL IV, and per employee all symptoms resolved and she was discharged. She reports no further problems.
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| 64 | 2021-01-04 | nausea |
ON 12/31, DEVELOPED BODY ACHES, NAUSEA, SWOLLEN LYMPH NODES UNDER ARMS AND NECK. INJECTION SITE WAS ...
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ON 12/31, DEVELOPED BODY ACHES, NAUSEA, SWOLLEN LYMPH NODES UNDER ARMS AND NECK. INJECTION SITE WAS VERY SORE. RESOLVED AFTER 48 HOURS.
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| 64 | 2021-01-04 | vomiting, nausea | headache,nausea and vomiting ,chills |
| 64 | 2021-01-05 | nausea, abdominal discomfort |
I got the vaccine at 9am. At 4pm that same day I experienced terrible pain to left arm. No redness o...
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I got the vaccine at 9am. At 4pm that same day I experienced terrible pain to left arm. No redness or swelling at the site. I couldnt lie on my left arm at all that night. By 11pm I also experienced headache, sinus drainage, sore throat, body aches, taste and smell were off, upset stomach, queezy stomach but no nausea or vomiting, very weak , dry mouth, fever at 99.2 then 98.6, chills, lots of chills. The covid hotline at my work told me I had a moderate reaction to the vaccine. Treatment was rest and tylenol which didn't alleviate any symptoms whatsoever. I had all these symptoms til Jan 6th at 4am. At 4am all the symptoms left and have not returned.
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| 64 | 2021-01-06 | decreased appetite |
At twelve hours post injection I awoke with severe chills even though I did not have a temperature. ...
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At twelve hours post injection I awoke with severe chills even though I did not have a temperature. After taking 1000 mg of Tylenol the chills past in approximately an hour. The rest of the day I had extreme fatigue, headache, lethargy, and loss of appetite. By the next morning I still had the fatigue and weakness which improved gradually over the next 12 hours.
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| 64 | 2021-01-06 | diarrhea |
Patient contacted provider 12/26 with following symptoms: Dry cough, diarrhea, fatigue for 7 days. C...
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Patient contacted provider 12/26 with following symptoms: Dry cough, diarrhea, fatigue for 7 days. Covid test ordered and positive. presented to ED on 12/31 and admitted into hospital. Still inpatient as of 1/7/2021.
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| 64 | 2021-01-06 | diarrhea |
I exp headache and diarrhea The next day after I was urinating blood. I went to my PCP I got Culture...
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I exp headache and diarrhea The next day after I was urinating blood. I went to my PCP I got Culture and given antibiotics.
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| 64 | 2021-01-07 | indigestion |
No injection site issue from elbow to wrist swallen red fevered area hand was difficult to be used...
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No injection site issue from elbow to wrist swallen red fevered area hand was difficult to be used for 12-24 hours to subside . Very large arm left 2 - inches red a swallen 12-24 hours welts all over body three to five inches. Continuing every day . 120 dexitrun Cycles 16th day woke up intergestion roof of mounth Employee health hospialize Adverse event allergiest umulize hopital, clarifein, swelling
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| 64 | 2021-01-07 | vomiting, nausea | Pt. states that she developed nausea and vomiting for one day, no treatment, resolved on 01/06/2021 |
| 64 | 2021-01-08 | diarrhea, nausea | Nausea, diarrhea, low grade fever. Lasted 4 days, treated with Zofran |
| 64 | 2021-01-08 | nausea | Developed shingles on right side at waist. Pain, nausea, ltching |
| 64 | 2021-01-09 | abdominal pain, vomiting |
Violent chills, headache, abdominal pain especially on the right side and vomiting. Muscular aches...
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Violent chills, headache, abdominal pain especially on the right side and vomiting. Muscular aches all over the body. Fatigue. 1/10/21: Still experiencing headache and muscle pain, occasional chills.
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| 64 | 2021-01-09 | nausea |
Developed significant aching in lower extremities, HR 100, Temp 100.4, slight nausea, general flu l...
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Developed significant aching in lower extremities, HR 100, Temp 100.4, slight nausea, general flu like feeling
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| 64 | 2021-01-10 | abdominal discomfort, retching | GI upset, body aches, dry heaves |
| 64 | 2021-01-10 | abdominal discomfort, retching | GI upset , body aches, dry heaves |
| 64 | 2021-01-10 | abdominal pain |
At 15 minutes developed abdominal pain, facial redness, heat and burning. Lasted 2 hours and self ab...
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At 15 minutes developed abdominal pain, facial redness, heat and burning. Lasted 2 hours and self abated. On day 4 developed new onset food and flower allergies which lasted until day 10. These were lip tingling, eye swelling and redness and burning.
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| 64 | 2021-01-10 | nausea, diarrhea, vomiting | Headache Neck pain Fever/Chills Nausea/Vomiting Diarrhae |
| 64 | 2021-01-10 | nausea |
8th Jan-1430-tired 9th Jan-tired, nauseated, aches/body, chills 10th Jan-nauseated, tired, chills, a...
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8th Jan-1430-tired 9th Jan-tired, nauseated, aches/body, chills 10th Jan-nauseated, tired, chills, aches-body 11th Jan -aches-body, tired, nauseated, Headache
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| 64 | 2021-01-10 | nausea |
8th Jan@1430-Tired 9th Saturday-tired, nauseated, aches, chills 10th Jan Sunday-nauseated, tired, ch...
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8th Jan@1430-Tired 9th Saturday-tired, nauseated, aches, chills 10th Jan Sunday-nauseated, tired, chills, aches-body 11th Jan Monday-aches-body, tired, nauseated, Headache-Treatment-none, When she can she eats a little & drinks when not nauseated
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| 64 | 2021-01-10 | retching, nausea |
blasting headaches; chills all night; dry heaving all night; Nausea; no fever but her skin felt hot;...
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blasting headaches; chills all night; dry heaving all night; Nausea; no fever but her skin felt hot; sore left arm; This is a spontaneous report from a contactable nurse for herself. This 64-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 18Dec2020 at single dose on left upper arm (lot: EKS730), via an unspecified route of administration on 05Jan2021 14:30 at single dose (lot: EL1284 or EKI284) for COVID-19 immunisation. Medical history and concomitant medications were none. The patient did not have anything with the first shot except a sore left arm on 18Dec2020. She stated that if she lays on left side it is sore. The patient had the sore left arm both times that she got the vaccine. She got second dose of vaccine on 05Jan2021 at 2:30pm and had a blasting headache and just had chills that went away about hour ago on 05Jan2021. She did not have a fever but her skin felt hot on 05Jan2021. She stated that she had dry heaves on 05Jan2021. The patient started that she had a blasting headache within a few hours of the vaccine and it gradually got worst by the time she went to bed. Stated that the chills and dry heaves started then and throughout the night. The chills stopped an hour before she got up. Stated that she went to check her temperature and did not have a fever despite having chills and her skin feeling hot. Stated that nausea started about 10 at night on 05Jan2021. Seriousness for blasting headache, chills and dry heaves was disabling, for nausea was medically significant, for other events was non-serious. The patient took Ibuprofen for the headache. Stated that she was going to try to drink something. The outcome of sore left arm was not recovered; of chills was recovered on 06Jan2021. The outcome of other events was recovering. The causality for blasting headache, chills, dry heaves, nausea and skin felt hot was related (Source of assessment: Primary Source Reporter, Method of assessment: Agency Information on the batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the headache, chills, dry heaves and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 64 | 2021-01-11 | decreased appetite, diarrhea |
Pfizer-BioNTech COVID-19 Vaccine EUA 64-year-old female presents as a rapid response team patient st...
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Pfizer-BioNTech COVID-19 Vaccine EUA 64-year-old female presents as a rapid response team patient status post immunization her second shot was done on Tuesday 2 days ago. She had some diarrhea last night and had some body aches in her arms following the rules today she woke up did not eat breakfast which is not abnormal for her did have some coffee came to work describes some myalgias and felt sweaty felt chilled so she went downstairs had a glass of orange juice to see if that would help had a small helping of hashbrowns did not help she was so she went to employee health in the then was sent here for further evaluation. Patient denies any heart or lung problems high blood pressure diabetes has URI symptoms. No history of PEs or DVTs denies hypertension she fell your blood sugar is low but has no documented history of hypoglycemia is not on any hypoglycemic medications. No history of PEs or DVTs no travel or surgeries. No nausea or vomiting with the diarrhea. Also complains of body aches.BP 120/69 | Pulse 76 | Temp 37 °C (98.6 °F) (Oral) | Resp 21 | Ht 1.676 m (5' 6") | Wt 198 lb (89.8 kg) | SpO2 95% | BMI 31.96 kg/m² Labs reviewed on the chart are normal symptomatically she feels better offered Toradol for myalgias she refused she I suspect is having a reaction/side effect not an allergic reaction to her vaccination she received. Patient discharged.
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| 64 | 2021-01-11 | indigestion | Recipient reported heartburn sensation, chills, fatigue. |
| 64 | 2021-01-11 | nausea, decreased appetite |
at day 18 or 19, post first covid vaccine shot, I began to have many symptoms and did not feel well....
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at day 18 or 19, post first covid vaccine shot, I began to have many symptoms and did not feel well. These were chills, slight fever, no appetite, nausea, muscle aches, fatigue
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| 64 | 2021-01-11 | nausea, vomiting, difficulty swallowing |
Difficulty swallowing, fever 102, headache, ears plugged, earaches, all joints ache including finger...
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Difficulty swallowing, fever 102, headache, ears plugged, earaches, all joints ache including fingers, ankles, etc., legs ache, shinbones ache, roots of teeth ache, chills, nauseous, dizzy, delirious, ovaries ache, short of breath, brain fog, not able to multitask, vomiting, sore throat, cough, left arm pain
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| 64 | 2021-01-11 | nausea |
fatigue; Nausea; Headache; chills; This is a spontaneous report from a contactable other health care...
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fatigue; Nausea; Headache; chills; This is a spontaneous report from a contactable other health care professional (HCP) reporting for herself. A 64-year-old not pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number: EK9231, Intramuscular on right arm on 05Jan2021 at single dose for COVID-19 immunization. Medical history included Covid-19 and allergy to penicillin. Concomitant medications were not provided. Patient did not receive other vaccine in four weeks. On 05Jan2021 patient experienced nausea, headache, chills, fatigue. She was not treated for the events. Patient had not been tested for COVID-19 post vaccination. Patient was recovering from the events, at the time of the report.
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| 64 | 2021-01-11 | vomiting, nausea |
Nausea; Chills; sweats; vomit; This is a spontaneous report from a non-contactable consumer (patient...
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Nausea; Chills; sweats; vomit; This is a spontaneous report from a non-contactable consumer (patient). A 64-year-old female patient received the first dose of BNT162B2 (Lot number and expiry date unknown), via an unspecified route of administration on 02Jan2021 14:15 at SINGLE DOSE in the left arm for COVID-19 immunization. Medical history included depression from an unknown date. Concomitant medication included marijuana, depression meds and sleep meds. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Jan2021 04:00, the patient experienced nausea, chills, sweats and vomit. The patient did not receive any treatment for the events. The outcome of the events was not recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
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| 64 | 2021-01-12 | abdominal pain, diarrhea, nausea |
Systemic: Chills-Severe, Systemic: Exhaustion-Severe, Systemic: Fever-Severe, Systemic: Headache-Sev...
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Systemic: Chills-Severe, Systemic: Exhaustion-Severe, Systemic: Fever-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Systemic: Unable to Sleep-Severe, Systemic: Abdominal Pain-Severe, Systemic: Diarrhea-Severe, Systemic: Nausea-Severe, Systemic: Swollen Hands. Couldn't make fist-Severe; symptoms lasted 4 days.
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| 64 | 2021-01-12 | diarrhea, nausea, abdominal pain |
Systemic: Chills-Severe, Systemic: Exhaustion-Severe, Systemic: Fever-Severe, Systemic: Headache-Sev...
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Systemic: Chills-Severe, Systemic: Exhaustion-Severe, Systemic: Fever-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Systemic: Unable to Sleep-Severe, Systemic: Abdominal Pain-Severe, Systemic: Diarrhea-Severe, Systemic: Nausea-Severe, Systemic: Swollen Hands. Couldn't make fist-Severe; symptoms lasted 4 days
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| 64 | 2021-01-12 | diarrhea | Numbness of tongue, change in taste, congestion, body aches, diarrhea, cough |
| 64 | 2021-01-12 | nausea | Chills, body aches, malaise, nausea |
| 64 | 2021-01-12 | nausea | Light nausea |
| 64 | 2021-01-12 | nausea |
I developed a headache and nausea that lasted 36 hours. Headache gone after the 36 hours but still h...
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I developed a headache and nausea that lasted 36 hours. Headache gone after the 36 hours but still have some nausea 48 hours later. I am fine, but wanted to at least let you know that's how the second shot affected me. I had no reaction other than a sore arm after the first injection. I did not need to seek medical attention.
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| 64 | 2021-01-12 | nausea |
Arm pain; Nausea; lightheadedness; This is a spontaneous report from a contactable healthcare profes...
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Arm pain; Nausea; lightheadedness; This is a spontaneous report from a contactable healthcare professional (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: not provided), via an unspecified route of administration on the left arm in Jan2021 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included hypothyroidism. It was reported that the patient had allergies with sulfa and trimethoprim / sulfamethoxazole (BACTRIM). Concomitant medications included levothyroxine sodium (SYNTHYROID), ergocalciferol (VIT D), levocetirizine dihydrochloride (XYZAL). It was stated that the patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. In Jan2021, the patient experienced arm pain after 10 hours of getting the vaccine. It was also reported that nausea and lightheadedness the following day. No treatment received for the adverse events. The patient recovered from the events in Jan2021 (reported as feeling passed after 2hrs) Information on the lot/batch number has been requested.
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| 64 | 2021-01-13 | vomiting, nausea |
Temp 101.6, chills, extreme body aches and HA, nausea, vomiting, hyperactive bowel movements, (7 sof...
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Temp 101.6, chills, extreme body aches and HA, nausea, vomiting, hyperactive bowel movements, (7 soft formed in 9 hours) resolved about 30 hours from onset.
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| 64 | 2021-01-14 | difficulty swallowing, nausea |
burning of the tongue; Difficulty in breathing; headaches; Pressure in the chest area; nausea; dizzi...
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burning of the tongue; Difficulty in breathing; headaches; Pressure in the chest area; nausea; dizziness; fast heartbeat; tiredness; Had a hard time swallowing at night from the dryness; bitter taste; her mouth went completely dry; patient received 0.45 mL, single dose (225mcg) of PFIZER-BIONTECH COVID-19 VACCINE; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration on 23Dec2020 15:00 at 0.45 mL, single dose (225mcg) at left arm to prevent COVID. Medical history included a bout of dry mouth about 7 years ago, no other relevant medical history (including any illness at time of vaccination). The patient's concomitant medications were not reported. There's no adverse events following prior vaccinations. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. From the time she got the vaccine her mouth went completely dry on 23Dec2020 and she kept thinking it would go away and she still had it. Event was reported as serious per medically significant. Had a hard time swallowing at night from the dryness. Patient had the bitter taste was also on 23Dec2020, but it went away. It lasted about 5-6 hours. Then after that the dry mouth started right after. It is tolerable but she still had it. Mentioned she had a bout of dry mouth about 7 years ago and it did go away, but she never got a diagnosis for it. Patient thought that something underlying may have triggered it again. Patient also experienced burning of the tongue, tiredness, headaches, pressure in the chest area similar to difficulty in breathing, nausea, dizziness, and a fast heartbeat on unspecified date. Outcome of event dry mouth was not recovered, outcome of event bitter taste was recovered on unspecified date in Dec2020, outcome of other events was unknown. No family medical history relevant to adverse events. No relevant tests. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Relatedness of Pfizer BioNTech Covid-19 vaccine with dry mouth and bitter taste per primary source reporter with method of assessment of global Introspection was related. Reporter seriousness for event bitter taste was not serious.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of dry mouth cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 64 | 2021-01-14 | nausea |
Employee reported having SOB with chest pains, severe headache (rated pain as 8/10), excessive saliv...
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Employee reported having SOB with chest pains, severe headache (rated pain as 8/10), excessive salivation with nausea, lightheadedness, she has a h/o migraines headaches and was incapacitated for 24 hours, Employee she was treated and sent home by end of her scheduled shift
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| 64 | 2021-01-16 | blood in stool, abdominal pain lower |
Saturday morning 1/16/2021, had LLQ abd pain, crampy. Has a BM and was very small. Later followed by...
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Saturday morning 1/16/2021, had LLQ abd pain, crampy. Has a BM and was very small. Later followed by a dime size of mucous and then later a dime size of bright red blood. No history of rectal bleeding prior. Later in the had more cramping and passed addition medium BM with blood not in stool. Noted for one day only. No idea if this is related to vaccine, but was an unusual occurrence four days after vaccine.
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| 64 | 2021-01-17 | nausea |
Extremely sore arm, muscle aches, headache, slight nausea, fatigue. Onset 12 hours after administra...
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Extremely sore arm, muscle aches, headache, slight nausea, fatigue. Onset 12 hours after administration. Effects lasted for 3 days despite round the clock Tylenol dosing.
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| 64 | 2021-01-17 | nausea |
Headache, total body muscle aches, chills, slight nausea, fatigue, arm soreness lasting for 3 days. ...
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Headache, total body muscle aches, chills, slight nausea, fatigue, arm soreness lasting for 3 days. tiredness and muscle soreness, intermittent nausea lasted for 5 days
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| 64 | 2021-01-17 | nausea |
severe headache; nausea; chills; sinus pain; cough; joint pain; Bedridden; Arm still sore at 60 hour...
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severe headache; nausea; chills; sinus pain; cough; joint pain; Bedridden; Arm still sore at 60 hours; This is a spontaneous report from a contactable other Health Professional (patient). A 64-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number= EH9899), via an unspecified route of administration on 07Jan2021 10:30 at single dose in right arm for covid-19 immunization. Medical history included hypertension (Htn), chronic kidney disease (CKD), the patient had known allergies to ibuprofen, bee stings. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EH9899), on 17Dec2020 at the single dose for covid-19 immunization and experienced very sore arm. Concomitant medications the patient received within 2 weeks of vaccination reported as yes. The patient experienced severe headache, nausea, chills, sinus pain, cough, and joint pain for 24 hrs; headache and nausea continued another 12 hours. Bedridden first 24 hours. Arm still sore at 60 hours on 07Jan2021 22:00. The patient did not receive any treatments. The outcome of the events was recovering.
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| 64 | 2021-01-18 | decreased appetite, nausea |
Physical exhaustion, slept all afternoon, Got up around 6PM and went back to bed at 9 and slept fro...
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Physical exhaustion, slept all afternoon, Got up around 6PM and went back to bed at 9 and slept from 9 AM till the next morning at 8AM. Felt tired all morning and no appetite ,and felt nauseous. Began feeling better around 2 PM.
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| 64 | 2021-01-18 | nausea | Extreme nausea starting at three. Eased up some by 7:30 pm after eating some crackers |
| 64 | 2021-01-19 | diarrhea |
Worsening diarrhea at onset followed by significant fatigue, weakness, and vibratory sensation in ar...
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Worsening diarrhea at onset followed by significant fatigue, weakness, and vibratory sensation in arms and legs Exam on 19 Jan 2021 revealed hyperreflexia and slightly spastic gait concerning for transverse meylitis
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| 64 | 2021-01-19 | nausea, vomiting |
Fever 101.5, migraine, eyepain, severe arthralgias, nausea and vomiting, weakness, inability tji ...
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Fever 101.5, migraine, eyepain, severe arthralgias, nausea and vomiting, weakness, inability tji think clearly. Residual symptoms at the time of this report
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| 64 | 2021-01-19 | nausea |
On second day after vaccine-1/8/21-shakes, chills, left arm swollen, bruised, tender, warm, and sore...
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On second day after vaccine-1/8/21-shakes, chills, left arm swollen, bruised, tender, warm, and sore with a knot at injection site. Nausea and fever of 101.8-patient took Zofran=8mg. All over body aches and joint tenderness and soreness. Day 3-1/9/21-extreme fatigue and body aches, no fever or chills. Day 4 and 5 only had headaches, and on Day 6 no symptoms at all.
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| 64 | 2021-01-20 | nausea | Elevated T of 100.3, body muscle/joint pain; severe headache, nausea, dizziness |
| 64 | 2021-01-20 | nausea |
Approx. 10-12 post immunization, pt. reports dizziness and nausea. She refused to lay down, remained...
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Approx. 10-12 post immunization, pt. reports dizziness and nausea. She refused to lay down, remained in wheelchair. She asked for cola, it helped settle stomach. As dizziness subsided she had HA. We observed her for an additional 30 min. until dizziness gone. She still had some nausea & HA. Hx: migraines. (She often feels dizzy/nausea prior to migraines)
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| 64 | 2021-01-21 | abdominal pain | Abdominal pain for 3 days and then better |
| 64 | 2021-01-21 | nausea | chills, skin hurts, headache, nausea, body aches, muscle aches |
| 64 | 2021-01-22 | diarrhea, abdominal pain, abdominal pain lower | Severe lower abdominal pain and cramping along with sever diarrhea |
| 64 | 2021-01-22 | diarrhea, nausea | Hives,achy,fever,nausea,headache,diarrhea |
| 64 | 2021-01-23 | nausea |
I am reporting the following reaction, as I was unable to enter it on V-safe due to the site not fu...
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I am reporting the following reaction, as I was unable to enter it on V-safe due to the site not functioning properly. Twelve hours post vaccination: onset of shaking chills, temperature 101 F, severe headache, nausea, myalgia, arthralgia and fatigue Twenty four hours post vaccination: severe headache and moderate nausea, myalgia, arthralgia and fatigue, temperature 98.8F Forty eight hours post vaccination: moderate headache, mild nausea and fatigue Seventy two hours post vaccination: slight headache, nausea and fatigue Ninety six hours post vaccination: symptoms resolved
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| 64 | 2021-01-23 | nausea |
chills, headache, nausea, sleepiness, body aches for 2 days. Took Tylenol every 4 hrs. for 24 hrs. ...
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chills, headache, nausea, sleepiness, body aches for 2 days. Took Tylenol every 4 hrs. for 24 hrs. Felt better by day 3.
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| 64 | 2021-01-24 | diarrhea |
ran low grade fever 12/19/2020 ,12/20/2020 Fever, fatigue 12/22/2020 sever diarrhea , 12/26/2020 fe...
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ran low grade fever 12/19/2020 ,12/20/2020 Fever, fatigue 12/22/2020 sever diarrhea , 12/26/2020 feeling worse and worse and tested on 12/26/2020 on 12/28-29/2020 shortness of breath and admitted on 12/31/2020
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| 64 | 2021-01-25 | nausea, diarrhea |
Has arthritis prior to having the COVID vaccine and after getting it, it went after the over growth ...
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Has arthritis prior to having the COVID vaccine and after getting it, it went after the over growth bones in her hands; She still has a cough and no taste; She still has a cough and no taste; The doctor didn't know what to tell, they said if they were her, they would not take the second shot; Body aches; Chills; Nausea; Tired; Diarrhea; Had a fever reached 100.0; Joint hurt, all of them; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunisation. Medical history included COVID-19 in Nov2020 (8 weeks ago). Concomitant medications were not reported. After getting the vaccine, she got sick as a dog and couldn't work. She had a fever that reached 100.0, she had body aches. It was explained that she has arthritis prior to having the COVID vaccine and after getting it, it went after the over growth bones in her hands. The caller continues that her joint hurt, all of them, but it was throbbing the most where she has visual arthritis. To sum it up, she had chills, nausea, and body aches the first day. The caller took Tylenol regardless of what the paper said; this was on Friday, 08Jan2021. She kept taking the Tylenol. The next day, she was still tired but when she quit taking the Tylenol on the 2nd day the symptoms returned. It was clarified that she took it in the beginning of the second day twice but at the end of the day wanted to see if she was over it all so she stopped the Tylenol. The symptoms all returned so she took again at bed time, the Tylenol, this was Saturday. On Sunday, she had diarrhea but only a couple times and though it was weird, after that is was over. That day she took Tylenol once. She was calling because she was scared about the second dose, this one produced a big immune response and she says that usually happens with the second dose. The caller wants to know if she should take the second shot, she doesn't want to have this happen again or it be worse. She thought since she had already had COVID it wouldn't be as bad, her immune response. The first dose was given on 07Jan2021. It was explained the only thing unresolved was from when she had COVID, she still has a cough and no taste. There are just few thing she can taste and smell now. The patient said that all the symptoms had resolved as of Monday, the 11Jan2021. Actually, she felt pretty good on the 10Jan2021 so let's say Sunday. She explained that most people get this on the second dose and so if she going have a third response she doesn't want the second dose. She was calling to get an answer to her question, the doctor told her to call to see what could be recommended. She has really good doctors, three of them. The doctor didn't know what to tell, they said if they were her, they would not take the second shot. The patient said she really needs to go. No need to continue when there is no one to tell her if she should take the second shot or not. The patient asked to be contacted via email to relay information about people's immune response to the first dose verses the second dose, is it greater or less. Clinical outcome of the events recovered on 11Jan2021. Information on the Batch/Lot number has been requested.
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| 64 | 2021-01-25 | nausea, vomiting | Nausea and Vomiting this morning at 8:30 am on 1/26/21. Slight headache yesterday. |
| 64 | 2021-01-26 | nausea |
Patient received Covid Vaccine Dose 1 on 01/25/2021. Patient states within 15-20 mins of receiving d...
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Patient received Covid Vaccine Dose 1 on 01/25/2021. Patient states within 15-20 mins of receiving dose, felt extreme coldness from shoulder to tips of fingers for about 30 mins and then resolved. Then afterwards, started to develop redness/itching/hives on back. Patient also felt very lightheaded and blood pressure taken and elevated at 188/84. (20-25 mins after injection). Injection site did swell and got red after. Also had mild HA after arriving home but didn't last long & nauseous feeling the whole day after getting vaccine. Patient did not take any medications and all symptoms resolved on own.
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| 64 | 2021-01-26 | nausea |
Fever to 101.2 x 12 hrs. Continued fever at 100 through 24 hrs. Total body aches. Chills. Nausea...
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Fever to 101.2 x 12 hrs. Continued fever at 100 through 24 hrs. Total body aches. Chills. Nausea. Severe headache. All mostly resolved in a total of 36 hrs.
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| 64 | 2021-01-26 | nausea | VERTIGO, CHILLS, NAUSEA, HEADACHE, LEFT ARM ARM UP TO BASE OF SKULL |
| 64 | 2021-01-26 | vomiting | A cough and then vomiting |
| 64 | 2021-01-27 | abdominal discomfort, diarrhea, abdominal pain, nausea |
abdominal cramping; Diarrhea; she could hardly walk this morning; muscle ache; arm is a little sore;...
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abdominal cramping; Diarrhea; she could hardly walk this morning; muscle ache; arm is a little sore; nausea; GI problems; This is a spontaneous report from contactable consumer (patient). This 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EL0142), via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications included ongoing evolocumab (REPATHA, Expiration Date: 04Nov2021), ongoing amlodipine besilate (NORVASC, Strength: 10 mg) as high blood pressure medication, and ongoing amlodipine (Strength: 5 mg) as high blood pressure medication. The patient previously took first dose of BNT162B2 (Lot number: EJ1685) for COVID-19 immunisation. On 12Jan2021, patient got the second dose of the Pfizer COVID vaccine. She did fine all day, but then she started to feel a little nauseous off and on. Then at 4 o'clock before she left for work she developed muscle ache on 12Jan2021. It persisted to the point she could hardly walk this morning (13Jan2021). Patient has not had a fever. She hasn't really had a headache. It has just been muscle aches. Her arm was a little sore on 12Jan2021 but not bad. She has had muscle ache and GI problems with it. She had waves of nausea like she could throw up. She was hydrating really well. The nausea came and went. The muscle aches started at 3:30 to 4 with muscles aching. She got the vaccine to help prevent the spread of COVID and to protect herself as well. Patient experienced abdominal cramping and diarrhoea on 13Jan2021. Outcome of nausea and arm was a little sore was recovering, outcome of muscle ache, abdominal cramping and diarrhea was not recovered, outcome of other events was unknown.
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| 64 | 2021-01-27 | flatulence, abdominal distension, diarrhea | Sore arm, Bloating, gas and diarrhea |
| 64 | 2021-01-27 | nausea | H/A with nausea and dizziness, slight congestion. lasted 1/2 day |
| 64 | 2021-01-27 | nausea |
Low grade fever/fever; Chills; Body ache/whole body aches; Nausea/I am getting nauseated; Not feelin...
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Low grade fever/fever; Chills; Body ache/whole body aches; Nausea/I am getting nauseated; Not feeling well; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) , via an unspecified route of administration on 13Jan2021 at a single dose as patient works in a Healthcare Facility, also under the recommendation of her physician (COVID-19 immunization). Medical history included cardiomyopathy and patient has pacemaker defibrillator. Concomitant medication included sotalol. The patient had the injection (patient described the product as Pfizer EL3246) yesterday, the first dose and about 2 o'clock this morning (14Jan2021) she woke up and have been having symptoms, the side effect symptoms, she had fever, the chills, the body ache, the nausea and just not feeling well at all. The patient was still experiencing the events. The patient stated that they are actually kind of getting worse, she was getting nauseated, her entire whole body aches, not feeling well at all, she had a fever, she just took temp of herself and she has a low grade fever. No treatment was administered for the events. The outcome of the events was not recovered. Information on lot number has been requested.
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| 64 | 2021-01-27 | vomiting, diarrhea | Fever, diarrhea. Vomiting, body aches, headache, back of neck aches, pain at site of shot |
| 64 | 2021-01-27 | vomiting |
patient developed a fever right after injection, went up to 103.5 overnight, called off work the fol...
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patient developed a fever right after injection, went up to 103.5 overnight, called off work the following day sick - headache and vomiting
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| 64 | 2021-01-28 | nausea |
headache, bone and muscle aches on left side (collar bone, shoulder blade, rib cage, neck, back), fe...
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headache, bone and muscle aches on left side (collar bone, shoulder blade, rib cage, neck, back), fever (99.5-100.5 for 1+ days), nausea (5+ days)
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| 64 | 2021-01-28 | nausea |
The day at 7:00 PM symptoms started with headache, chills, temperature, fatigue, nausea. 48 hours l...
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The day at 7:00 PM symptoms started with headache, chills, temperature, fatigue, nausea. 48 hours later your feeling much better. Took Tylenol and also Ibuprofen and stayed hydrated. Also had arm soreness, which she had with 1st vaccine as well.
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| 64 | 2021-01-31 | nausea |
Approximately 24 hours after COVID 19 vaccine administered, started with headache, body aches and ch...
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Approximately 24 hours after COVID 19 vaccine administered, started with headache, body aches and chills and fatigue. Occasional nausea but no vomiting. Lasted from 1/29/21 to 2/1/21.
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| 64 | 2021-01-31 | nausea |
Fever; Muscles started to ache; Headache; Nauseous; doesn't feel good; Arm is sore; This is a sponta...
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Fever; Muscles started to ache; Headache; Nauseous; doesn't feel good; Arm is sore; This is a spontaneous report from a contactable consumer reporting for herself. A 64-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were unknown), via an unspecified route of administration, on 11Jan2021, at a single dose for COVID-19 immunization. Medical history and concomitant medications were none. The patient reported that she received her COVID Vaccine on Monday afternoon 11Jan2021. The patient experienced events doesn't feel good and her arm is sore on an unspecified date in Jan2021. On 11Jan2021, after she got the shot, an hour after she started getting nauseous. On Tuesday, 12Jan2021, she experienced headache that went away the next day. On 13Jan2021, her muscles started to ache. That lasted on Wednesday (13Jan2021), Thursday (14Jan2021). On Friday (15Jan2021) afternoon, when she got home from work, she started running a fever and at the time of report she was still running a fever. She stated, "as of right now starting yesterday afternoon, I've got my fever, I don't feel good, I ache, my arm is sore but that's okay. It started Monday afternoon after I got the shot, an hour after I started getting nauseous that was Monday afternoon. Tuesday, I got headache that went away on Wednesday. On Wednesday my muscles started to ache. And that was Wednesday, Thursday and Friday afternoon when I got home from work, I started running a fever and I am still running a fever." When confirmed if the consumer wanted to report the same or looking for some information, consumer stated, "I want to report this and I just want information, what do I do? I test twice a week, rapid test and saliva test for COVID. And I have tested negative for months. And I tested negative before I got the vaccination, I tested on Thursday (14Jan2021), I am still negative. That was the rapid test." The patient took ibuprofen as a corrective treatment for the reported adverse events. Outcome of the event headache was recovered on 13Jan2021, outcome of fever was not recovered, while outcome of the other events was unknown. Information on the lot/batch number has been requested.
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| 64 | 2021-01-31 | vomiting |
Patient received 2nd COVID vaccine on 1.28.2021. Patient states she experienced fever, vomiting, he...
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Patient received 2nd COVID vaccine on 1.28.2021. Patient states she experienced fever, vomiting, headache, and body aches beginning a few hours after receiving the second vaccine. Patient states all side effects except for the fever have resolved as of this morning. Patient also reports that she began having hallucinations this morning (2/1). She says she is seeing spiders all over her home. Put the patient on hold and reached out to family practice staff. Patient states that hospice nurse is coming at 1:30pm today. I told the patient about informing her PCP due to the hallucinations. The patient does not voice any other complaints. Instructed the patient to seek emergency care for severe/concerning symptoms
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| 64 | 2021-02-01 | nausea |
Sore arm immediately after getting second dose of COVID Vaccine; Chills; Myalgia; severe headache; N...
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Sore arm immediately after getting second dose of COVID Vaccine; Chills; Myalgia; severe headache; Nausea; She felt like she had a temperature and by the time it was checked her temperature was 101.9/febrile; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at left upper arm on 07Jan2021 14:30 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital, not a Military Facility. The patient's medical history was none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient got the Flu Vaccine last part of Sep2020 or Beginning of Oct2020. The patient received the first dose of BNT162B2 (lot number: EK57530), via an unspecified route of administration at left Upper arm on 17Dec2020 9:10AM for covid-19 immunization. She only had a sore arm. It started the same day, a couple of hours after getting the vaccine. It went away a day to a day and a half after it started. After that she was fine. She got the second dose on 07Jan2021. After the second dose, immediately, like within five minutes her arm became very sore, this event was assessed as non-serious by HCP. Also, that Thursday (07Jan2021) night after getting the second dose of the Vaccine around 9PM-10PM she started to get chills, myalgia, severe headache, and nausea. She also mentioned she was so sick during the night she was not able to get up and around. She felt like she had a temperature and by the time it was checked her temperature was 101.9. She was febrile all through 08Jan2021. She started to become afebrile 09Jan2021 with improvement and by 10Jan2021 all her symptoms had gone away and completely resolved. Seriousness Criteria: Stated she felt these are serious. She was unable to go to work on Friday. She could not return back to work until Monday. The HCP assessed all events were related to the vaccine. The outcome of the events was recovered on 10Jan2021. She stated, even though she got so sick with getting the vaccine she was just continuously telling her self this is better than having COVID. She stated she even told people even if she knew after getting the shot she would have this reaction she would still take it. She has seen death occur from COVID and does not want that to happen.; Sender's Comments: Based on plausible temporal relationship, clinical course and known safety profile of the product, the reported events chills, myalgia, severe headache, nausea and fever were likely causally related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 64 | 2021-02-01 | nausea |
Pfizer-BioNTech COVID-19 Vaccine EUA: Was perfectly fine for the first 10 hrs following injection. T...
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Pfizer-BioNTech COVID-19 Vaccine EUA: Was perfectly fine for the first 10 hrs following injection. Then 11pm Sar night sudden intense pain at inj site spreading rapidly around back of neck and down other arm and up to head. Wracking chills for about 8 hours. Shaking uncontrollably, aches and pains, very weak, exhausted, nauseous. About 8 hours later, 7am Sunday, fever developed, eye pain with severe headache. In bed 30 hours. Monday morning felt much better but still fever @100 and weirdly dizzy. Ate and drank water. Today, almost 72 hours later fever gone, still very dizzy. Drinking water to see if that will help.
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| 64 | 2021-02-02 | nausea |
Flushing 10 min after injection followed by heart palpitations then increased blood pressure. I too...
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Flushing 10 min after injection followed by heart palpitations then increased blood pressure. I took 2 loratidine tablets and symptoms slowly subsided over the next 50 min. The next day had chills and nausea for 8-10 hr. The nausea lasted another 3-4 days.
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| 64 | 2021-02-03 | diarrhea |
more tired; Weakness; increased heart rate; Diarrhea; soreness at the injection site; Runny nose; Th...
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more tired; Weakness; increased heart rate; Diarrhea; soreness at the injection site; Runny nose; This is a spontaneous report from a contactable Nurse (patient). A 64-year-old female patient received BNT162B2 (Pfizer BioNTech COVID-19 vaccine), intramuscularly on 15Jan2021 at single dose into the left arm for COVID-19 prophylaxis. Medical history included asthma; blood pressure abnormal (she takes blood pressure medication); palpitations at times; having mild chest discomfort, had experienced this before, that she was attributing to her wearing a mask, she wore 2-3 masks; stated that she had Covid once and she did not want it again. Concomitant medications included some blood pressure medication, and salbutamol (ALBUTEROL) inhaler periodically. Caller is a LPN nurse that was calling about the Covid-19 vaccine and reported that she received it Friday 15Jan2021 and just wanted to report some mild side effects. Caller clarified that she was more tired, had weakness, had diarrhea for 2 days, increased heart rate, and a runny nose, soreness at the injection site . She stated that she was not in a lot of distress. More tired started from 17Jan2021 and soreness at the injection site started from 16Jan2021. Weakness started from 17Jan2021: She stated that went home straight from work and went to the couch and slept about 6 hours. She had been up since 0300 and it was almost 1200 now. She stated that her energy level and weakness was pretty good right now. Diarrhea started from 16Jan2021: She said that she had the urgency to go and it was definitely soft and foul like when you had the flu. She stated that she has had it once since this morning. It was semisolid. Increased heart rate started from 17Jan2021: she felt palpitations at times. She said that she did not know if they were related, but stated that they were aggravating yesterday. She stated that she took blood pressure medication. She stated that she used a inhaler albuterol. She was using her inhaler periodically and said that it could be because of the albuterol inhaler. Runny nose started from 15Jan2021: Runny nose started about 8-10 hours after her injection. Stated that it was not bad, she would just have to blow her nose really good every so often. She said that she has not had to blow her nose today since she had been up. She said that the vaccine was sitting on the table and they just told her it was the Pfizer BioNTech vaccine. She did not have her vaccination card with her at the time of the call. The patient had recovered from weakness on 18Jan2021, recovered from increased heart rate and soreness at the injection site on 17Jan2021; she was recovering from more tired, runny nose, and she had not recovered from diarrhea. Reporter seriousness for increased heart rate, runny nose and soreness at the injection site was not serious. The reporter (nurse) considered the events more tired, weakness, diarrhea, runny nose and soreness at the injection site were related to bnt162b2, and relatedness of bnt162b2 to reaction increased heart rate was unknown. Information on the lot/ batch number has been requested.
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| 64 | 2021-02-04 | diarrhea, nausea |
Head ache, nausea first day, second day diarrhea, fever, head ache and body aches. Third day injecti...
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Head ache, nausea first day, second day diarrhea, fever, head ache and body aches. Third day injection site red the size of a quarter, hot and sore to the touch and hard. Arm aches into shoulder.
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| 64 | 2021-02-04 | nausea, vomiting | Nausea, vomiting , headache, body ache |
| 64 | 2021-02-04 | nausea |
Sore Injection site left arm (same arm as first one) thru the armpit, swelling in left arm, tirednes...
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Sore Injection site left arm (same arm as first one) thru the armpit, swelling in left arm, tiredness & fatigue, foggy brained, extreme body aches and pain, unable to walk from weakness, nausea, excruciating headaches, irregualar heartbeat, nausea. Reddness and swelling in arm for over 1wk. Nausea about 10 days.
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| 64 | 2021-02-06 | nausea, vomiting |
Injection site: Bright Redness 2 inches in diameter, hardness, moderate pain, itching ; malaise; nau...
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Injection site: Bright Redness 2 inches in diameter, hardness, moderate pain, itching ; malaise; nausea; vomiting x 1; headache; chills; low-grade fever; myalgia; fatigue
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| 64 | 2021-02-07 | blood in stool, diarrhea, abdominal pain upper |
Severe lower stomach cramps; diarrhea; some bloody stool; This is a spontaneous report from a contac...
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Severe lower stomach cramps; diarrhea; some bloody stool; This is a spontaneous report from a contactable other healthcare professional reported for herself. A 64-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL32495-21), via an unspecified route of administration at Left arm on 20Jan2021 14:15 at single dose for COVID-19 immunization. Medical history included allergies to penicillin, allergies to Latex and allergies to shellfish. Concomitant medication included rosuvastatin calcium (CRESTOR), raloxifene hydrochloride (EVISTA), tramadol, ibuprofen 600 mg received within 2 weeks of vaccination. The patient previously took iodine and experienced allergies to Iodine, codeine and experienced allergies to codeine, oxytetracycline (TERRAMYCIN) and experienced allergies to Terramycin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe lower stomach cramps and diarrhea since 22Jan2021 19:30 and still having this issue to include some bloody stool on 22Jan2021 12:30. No treatment received for the events. The events were reported as non-serious. The patient was not pregnant. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 64 | 2021-02-07 | nausea |
shaking chills lasting 10 hours; severe frontal headache; nausea; intermittent dizziness; muscle pai...
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shaking chills lasting 10 hours; severe frontal headache; nausea; intermittent dizziness; muscle pain; joint pain; fatigue; This is a spontaneous report from a contactable nurse (patient herself). A 64-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302), intramuscular (left arm), on 20Jan2021 09:00, at single dose, for covid-19 immunization. Medical history included allergies: penicillin, sulfa, environmental. Concomitant medications included levothyroxine; cetirizine hydrochloride (ZYRTEC ALLERGY); calcium; and colecalciferol (VIT D3). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), on 30Dec2020 16:00, intramuscular (left arm), for covid-19 immunization at 64-years-old. The patient experienced, "10-11 hr" post injection, on 20Jan2021 20:00 started shaking chills lasting 10 hours. The patient also experienced on 20Jan2021 20:00 severe frontal headache with nausea and intermittent dizziness, muscle pain, joint pain, and fatigue - which all resolved after about 24 hr after onset. No treatment was received for these adverse events. The patient recovered from all the events on 21Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior to vaccination and have not been COVID tested post vaccination.
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| 64 | 2021-02-08 | abdominal pain, nausea |
37 hours after Pfizer injection, experienced severe abdominal pain that caused me to have vasovagal...
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37 hours after Pfizer injection, experienced severe abdominal pain that caused me to have vasovagal syncope. Started sweating, and I lost my vision, then must have fallen on the floor. When I came to, felt very headachy and nauseous. went to urgent care - they ordered an abdominal scan for 2/8/21 but scan did not reveal the cause of the pain. 8 hours later on 2/5/21, started feeling asthma like symptoms. Throat felt tight, voice became hoarse, kept having to cough because airway was starting to feel thickened. went to ER, they took vitals and told me that i wasn't having an allergic reaction because my symptoms were outside the time frame for an allergic reaction. After 3 hours there, they sent me home. Next morning felt like I was having heart palpitations. that feeling eventually went away if I walked around. But the following two mornings, I had the same feeling.
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| 64 | 2021-02-10 | difficulty swallowing | Rash on chest and arms. Difficulty swallowing for 2 days. Denies difficulty breathing. |
| 64 | 2021-02-14 | nausea |
first 48 hours fatigue, nausea, headache Day #9 post vaccine rash on Left upper arm and upper chest ...
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first 48 hours fatigue, nausea, headache Day #9 post vaccine rash on Left upper arm and upper chest Day #18 rash on Right arm
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| 64 | 2021-02-14 | nausea |
Pt. c/o nausea and being shaky. Pt was taken to observation room for assessment. Pt stated that la...
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Pt. c/o nausea and being shaky. Pt was taken to observation room for assessment. Pt stated that last well visit was in November which Doctor Lower doses of some meds. Pt ate some peanut cracker and had some water and started feeling better. BP 160/90, Pt was escorted to her car and SPO2 98%. Pt texted my Supervisor stating she made home just fine.
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| 64 | 2021-02-15 | nausea | On 2/7 at 01:00, woke up with headache, chills, fever, nausea and increased arm pain. |
| 64 | 2021-02-16 | nausea, vomiting |
I woke up 37 hours after first dose of vaccine with dizziness, which became dizziness. I began vomi...
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I woke up 37 hours after first dose of vaccine with dizziness, which became dizziness. I began vomiting within a couple hours. Around noontime I vomited twice more. I got worse, could not walk around. I felt extremely sick but felt better when I lay down in bed. I was not able to go to work, had to cancel the substitute teaching assignment I had taken. I did sleep some. No doctor called me back except my daughter texted with me. She is an intern, said she wished she could be with me. My neighbor brought some Pedialyte. This morning, the next day, I am still weak and nauseous, but it is less. At the end of the day yesterday, I did eat a little rice with carrots. And I just ate a little plain oatmeal with raisins and salt. I am praying the 2nd dose will not be worse, as my daughter warned, because I can't remember when I was so sick and incapacitated. Maybe a long time ago.
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| 64 | 2021-02-18 | nausea | Symptoms: Nausea; Rapid and Skipping Heartrate. Duration: 3 Days |
| 64 | 2021-02-19 | indigestion |
Within a few minutes of sitting in waiting zone, I had what I thought was severe heartburn. Simulta...
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Within a few minutes of sitting in waiting zone, I had what I thought was severe heartburn. Simultaneously I felt my heart racing and feeling flush. I raised my hand to alert attendant. Took pulse and it was very high. They called EMT. Upon connecting me to heart monitor is was erratic, Very high blood pressure. When they touched chest it hurt more. They said I was bright red. They transported me via residue to Hospital. Residual mild rash under skin for several days. Had severe headache for 14 hours.
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| 64 | 2021-02-19 | nausea |
extreme muscle pain (first 24 Hours) severe headache (first 24 Hours) Dull headache (Second and Thir...
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extreme muscle pain (first 24 Hours) severe headache (first 24 Hours) Dull headache (Second and Third day) Fatigue (every day) Nausea (first 24 Hours) Dizziness (every day) Took Tylenol on first day, later in the evening, and It really helped
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| 64 | 2021-02-22 | nausea, vomiting |
I had my 2nd dose of covid vaccine on 1/15, around 5 pm. Next day when I got up about 7:20 I felt d...
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I had my 2nd dose of covid vaccine on 1/15, around 5 pm. Next day when I got up about 7:20 I felt dizzy nausea and wanted to vomit. Then I passed out, I fell down and hit my face on the floor. My family called 911 paramedica. They ,measured d my blood pressure and it was too low. The area around my right eyebrow was swollen and my neck hurt as precaution I went to the hospital. I suspect the incident and its symptom are side effects of the vaccine given the timing. Later on I had headache off and on and brain fog.
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| 64 | 2021-02-22 | vomiting, diarrhea, nausea | Fatigue, muscle aches, chills, fever, nausea, diahrea, vomiting |
| 64 | 2021-02-23 | nausea | For 8 days: heavy fatigue, headache, For 3 days: rash For 5 days: nausea |
| 64 | 2021-02-24 | decreased appetite |
Pfizer Was the manufacturer 24 hours after receiving the vaccine, I started having headaches follow...
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Pfizer Was the manufacturer 24 hours after receiving the vaccine, I started having headaches followed by illness that remined me somewhat of getting the flu. Also, very tired and lack of appetite.
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| 64 | 2021-02-25 | diarrhea |
Severe diarrhea for 28 days now; This is a spontaneous report from a contactable nurse (patient). A ...
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Severe diarrhea for 28 days now; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El0142, expiry date not reported), via an unspecified route of administration at the left arm on 31Dec2020 14:00 at single dose for COVID-19 immunization. Medical history included asthma. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a public health clinic/veterans administration facility. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included prednisone and amoxicillin (AMOXYCILLIN). The patient experienced severe diarrhea for 28 days now on 02Jan2021 10:00. The adverse event resulted to doctor or other healthcare professional office/clinic visit as well as emergency room/department or urgent care. No therapeutic measure was taken as a result of the events. Clinical outcome of the event was not recovered.
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| 64 | 2021-02-25 | vomiting, nausea |
In 4 hours, started getting getting very dizzy, then throwing up, and nauseous by 7:30pm felt Luke o...
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In 4 hours, started getting getting very dizzy, then throwing up, and nauseous by 7:30pm felt Luke on worse six flag ride. Blood pressure went up to 166/106. Called 911. Diagnosed with possible reaction and developed TIA
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| 64 | 2021-02-25 | vomiting | severe vomiting |
| 64 | 2021-02-27 | decreased appetite |
With in seconds of receiving vaccine had seizure like effect in head resulting in out of body like e...
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With in seconds of receiving vaccine had seizure like effect in head resulting in out of body like experience, muffled hearing, a foul taste in my mouth and altered state of eurphoria. Could not report symptoms but if had been asked directly could have. REalised half way driving home that I should not be driving. Eurphoria lasted for 24 hours. Was on phone constantly the next day for 7 hours straight without eating. Could not remember what some items were like a drone. Had to ask = that thing that flies with a camera. Short term memory loss that continues. Facial numbness began 48 hours after injection. Facial numbness continues changing in areas of right side of my face. Felt extremely vulnerable. Wore my same clothing for 4 days as I did not remember that I had clean clothing. Did not remember that I should notify medical personal until late 2/20.
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| 64 | 2021-02-27 | diarrhea, nausea |
Site pain transferred to neck and down arm 2/25 6:00 pm lethargy; 7:00pm 2/25 8:30 low grade fever; ...
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Site pain transferred to neck and down arm 2/25 6:00 pm lethargy; 7:00pm 2/25 8:30 low grade fever; exhaustion 2/26 extreme fatigue; 2/27 extreme fatigue; nausea; diarrhea; headache
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| 64 | 2021-02-27 | nausea | TIRENESS, HEADACHES, NAUSEA, FELLING UNWELL, SOME ON AND OFF DIZZENESS. |
| 64 | 2021-02-28 | constipation, nausea |
Sweating, nausea, dizziness, aching joints. Effects seem to come in waves, sometimes feeling ok, an...
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Sweating, nausea, dizziness, aching joints. Effects seem to come in waves, sometimes feeling ok, and then completely down for a couple of hours, ending by day 3. Have been constipated for five days now, with no bowel movement since vaccine. I have had extreme insomnia since vaccine.
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| 64 | 2021-02-28 | nausea |
Headache; left arm is hurting from the shoulder; tired; Nauseous; injection site pain; This is a spo...
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Headache; left arm is hurting from the shoulder; tired; Nauseous; injection site pain; This is a spontaneous report from a contactable consumer (patient) and a contactable physician. A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), via an unspecified route of administration at arm left on 09Feb2021 at 14:10 (at the age of 64 years) at single dose for COVID-19 immunization. Medical history included ongoing Crohn's disease, ongoing allergies, ongoing blood cholesterol abnormal. Concomitant medication included mesalamine (strength: 400 mg) oral at 400 mg twice daily for Crohn's disease, atorvastatin oral at 400 mg once a day for blood cholesterol abnormal, azathioprine oral at 50 mg twice daily for Crohn's disease, cetirizine oral at 10 mg for allergies, vitamin D at 1000 iU daily for supplementation, ketotifen fumarate (strength: 0.025 %) ophthalmic twice daily for allergies and ipratropium bromide (strength: 0.06%) nasal daily for allergies, all from an unknown date and ongoing. The patient experienced sore at the injection site on 09Feb2021, headache on the left side and her left arm was hurting from the shoulder down and she feels really tired and nauseous, all on 12Feb2021. The patient outcome of injection site pain was recovered on 09Feb2021; the outcome of the other events was not recovered. The information on the batch number has been requested.
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| 64 | 2021-02-28 | nausea |
Within 30-45 minutes after injection, I started to feel a tingling around my jaw area. Then 3 days ...
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Within 30-45 minutes after injection, I started to feel a tingling around my jaw area. Then 3 days later I have had several episodes of dizziness, weakness and nausea. This has continued until today (4 days) along with aching across sholders and behind eyes.
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| 64 | 2021-02-28 | nausea |
Chills; headache; muscle and joint pain; muscle and joint pain; tiredness; nausea; Like a mild flu; ...
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Chills; headache; muscle and joint pain; muscle and joint pain; tiredness; nausea; Like a mild flu; This is a spontaneous report from a contactable other healthcare professional (patient). A 64-year-old female patient received the second dose of bnt162b2 (BNT162B2, lot number: EL 8982, expiry date: not reported), via an unspecified route of administration, on 26Jan2021 12:15 PM at a single dose on the right arm for COVID-19 immunization. The patient did not receive any other vaccine in four weeks prior to receiving bnt162b2. The patient was not pregnant. She was not diagnosed with covid prior to vaccination. Medical history included high bp (blood pressure) and type 2 diabetes. The patient previously received the first dose of bnt162b2 (BNT162B2, lot number: EL 1284, expiry date: not reported), on 05Jan2021 10:30 AM on the right arm for COVID-19 immunization (at the age of 64-year-old). On 26Jan2021 04:30 PM, the patient experienced chills, headache, muscle and joint pain, tiredness, nausea; like a mild flu. No treatment was received for the events. Outcome of the events was recovering. The patient was not tested for covid post vaccination. No follow up attempts are possible. No further information is expected.
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| 64 | 2021-03-01 | diarrhea |
Extreme edema at injection site, area about 4? x 6? Hot to the touch, itchy, red, still swollen afte...
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Extreme edema at injection site, area about 4? x 6? Hot to the touch, itchy, red, still swollen after 5 days. Overall itchy, but no rash. Thursday-Saturday diarrhea and lethargy Some intermittent vertigo. Rest, fluids, Tylenol and benedryl
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| 64 | 2021-03-01 | nausea, diarrhea, vomiting |
About four hours after the innoculation, I began to get nauseous. Three hours after that, I had vom...
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About four hours after the innoculation, I began to get nauseous. Three hours after that, I had vomiting and diarreah that lasted most of the night. I had chills, aches and headache which tylenol helped relieve. I began to feel better 24 hours later but still experienced extreme fatigue. It is now Tuesday (vaccine on Sunday) and I am still fatigued and have trouble concentrating.
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| 64 | 2021-03-02 | abdominal pain, abdominal pain upper |
very ill; very bad stomach issues; felt like someone was stabbing; couldn't eat/hadn't eaten for a c...
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very ill; very bad stomach issues; felt like someone was stabbing; couldn't eat/hadn't eaten for a couple of days; every time food reached her stomach, it was a horrible pain; fatigue; This is a spontaneous report from a contactable consumer (patient herself). A 64-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3284, NDC number and expiration date were unknown), intramuscularly in the left arm on 25Jan2021 at 12:30 at a single dose for COVID-19 immunization. The vaccination facility type was reported as the nursing home. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL0140, expiry date was unknown), on 04Jan2021 intramuscularly in the left arm for COVID-19 immunization. Relevant medical history included problems in blood pressure and sleep and restless leg syndrome; pain in legs; all from an unknown date and unknown if ongoing. Concomitant medications included amlodipine for blood pressure, gabapentin for restless leg syndrome; pain in legs, venlafaxine for antidepressant therapy, bupropion (also reported as the generic for Wellbutrin) for antidepressant therapy, and chlordiazepoxide to help sleep; all medications were ongoing. There were no additional vaccines administered on the same date of the Pfizer suspect. The patient had no prior vaccinations within 4 weeks. The patient worked at a nursing facility, but she was not a healthcare professional. After receiving the first vaccine, she felt great. The vaccine built her immunity up, which was good. With the second vaccine, she got very ill over it on an unspecified date. The patient was asking if there had been other people reporting side effects of the vaccine. The patient further reported that after she was given the second vaccine, they had a waiting time where she had to sit and wait about 15 minutes and it was fine. After work on an unspecified date, she had gone to pick up some groceries and it hit her like a ton of bricks. It was really, really bad. When she was given the vaccine, she asked the pharmacist from the time she was given the vaccine, if there would be any special time she would have symptoms or experience what would be going on. The pharmacist told her everyone was different, but that she would definitely know. The patient stated she had very bad stomach issues; it felt like someone was stabbing her on an unspecified date. She had no vomiting or diarrhea, but when she ate, it was horrible. She couldn't eat; every time food reached her stomach, it was a horrible pain. She also experienced some fatigue on an unspecified date. She got tired a lot. She had to call her employer and tell them that she wouldn't be coming in. This went on for a week. She still had some side effects, but its working its way out of her and she could tell. The patient stated she didn't believe her employer believed her. She had called and left messages and it went no where. She was afraid and she didn't want to lose her job. The patient stated that she really hadn't eaten for a couple of days at the time of the report. She asked one of the nurses where she worked if she should be drinking water and continue to try and eat and the nurse told her to drink as much water as she could and rest her body. The patient didn't believe her employer believed that this was actually happening to her. The patient was very upset that she could lose her job and she didn't know what to do or who else to call. The patient explained that mentally, she was feeling better, but her body hadn't caught up with her mind. The patient stated she needed any information to show that she spoke with Pfizer that she could give her employer. The adverse events (AEs) did not require any visit to an emergency room or the physician office. The patient had no investigation assessment and relevant tests. The outcome of all the events was unknown.
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| 64 | 2021-03-02 | diarrhea |
very active stomach, diarrhea due to problem (nervous)/bowel movement really often; very active stom...
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very active stomach, diarrhea due to problem (nervous)/bowel movement really often; very active stomach, diarrhea due to problem (nervous)/bowel movement really often; Stool being dark is concerning; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received second dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot EL8982), intramuscular in right arm on 29Jan2021 at SINGLE DOSE for Covid-19 immunisation. Medical history included high blood pressure and had insulin resistance. She had her first dose of BNT162B2 on 03Jan2021. Concomitant medication included metformin. She also mentioned 'Candistan Clotrimazole' (not clear nor clarified) something like that, and also took 'Premarin' (not clear nor clarified) it's hormone for menopause. She got the vaccine instead of 21 days it was 26 days. Since when she had the vaccine, her stomach was really active, diarrhea due to problem (nervous). She informed having bowel movements like really often. Today (Jan2021), she already went twice but the thing was she was going and it was like too dark, mentioned that stool being dark was concerning. She took Libertrim S11 Trimebutine Simethicone, for diarrhea. The outcome of events was unknown.
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| 64 | 2021-03-02 | difficulty swallowing |
Moderate anaphylactic reaction - according to doctor I consulted afterward. Throat swelled - diff...
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Moderate anaphylactic reaction - according to doctor I consulted afterward. Throat swelled - difficulty breathing and swallowing, weak, dizzy, rapid heart beat - started about 16-17 minutes after the vaccination. Lasted a little over 3 hours. Profound fatigue the next day.
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| 64 | 2021-03-03 | nausea, decreased appetite |
skin is burning up, her arms, her face, her stomach, her back, and her chest are burning up/burning ...
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skin is burning up, her arms, her face, her stomach, her back, and her chest are burning up/burning skin has probably gotten worse; Nausea; no appetite; Headache; bad sore throat; felt sick since she got it; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot: EL9262), via an unspecified route of administration on left arm (at the age of 64 years) on 24Jan2021 at single dose for covid-19 immunization. Medical history included type 2 diabetes (borderline about 15 years ago/started taking a medication a year ago for her high sugar numbers/had some blood tests, her A1C was normal, her diabetes was the same way it always has been); hypertension from 2012 (diagnosed about 9 years ago); sleep apnea from 2020 (uses a C-PAP machine/diagnosed approximately a year ago); Epstein Barr from 1995 (diagnosed when she was 39); high cholesterol (sometimes she didn't take her medication for that); cataract and cataract surgery in Jan2021 (had this last month/they used anesthesia/didn't know which type/had some eye drops for this). Concomitant medication included an unspecified high blood pressure medication (she thinks she tried a few times). The patient called about Pfizer COVID-19 vaccine and she had questions and side effects. She did get one shot, and was not due for her second for a couple weeks. The patient felt sick since she got it, some side effects have been less, some stayed the same or got worse. Her skin was burning up, her arms, her face, her stomach, her back, and her chest were burning up. She has done no treatment, because she didn't know what to do to treat it and it was difficult to be able to get in to see a doctor. The burning skin has probably gotten worse. She also had nausea and no appetite, though she has gotten a little better, it has been at least a full week or so. She had a headache and a bad sore throat also. She got home from getting the shot, probably maybe 5 or 6 hours after getting the shot. The patient's weight was 145-150lbs. The outcome of the event skin burning sensation was not recovered while for the remaining events was unknown.
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| 64 | 2021-03-04 | nausea | Dizziness, nausea, SOB, HTN and tachycardia |
| 64 | 2021-03-04 | nausea |
Residents was previously positive for Covid-19 on 6/17/20. She received both doses of the Pfizer va...
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Residents was previously positive for Covid-19 on 6/17/20. She received both doses of the Pfizer vaccine. She tested positive again for Covid-19 on 2/10/21.
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| 64 | 2021-03-04 | nausea |
I had severe COVID and was hospitalized on Dec 7, I was in hospital (non ICU setting) for 5 days an...
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I had severe COVID and was hospitalized on Dec 7, I was in hospital (non ICU setting) for 5 days and had O2, remdisiver and dethemethzone IV. I recovered fully, and have felt very good since mid January. My reaction after my 1st dose of vaccine on Feb 25 started 20 hours after shot. Worsened through the day and I got sicker at 24-36 hours, and then stayed in bed another day. Symptoms were identical to my bout with COVID: chills (no fever), nausea, aches in joints and muscles, fatigue. They were quite significant==I could not be out of bed. As it went along I also developed the feeling in my chest like COVID--tough to take deep breath, chest hurt---but my O2 readings were fine. Recovered after 48 hours, People who have had COVID should be aware that they will have a significant response to the vaccine on the 1st does. I am questioning having a second dose I have not reported this to my doctor
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| 64 | 2021-03-04 | vomiting, nausea |
Nausea, vomiting, pain under breastbone , tired unable to eat, has stayed in bed basically from the...
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Nausea, vomiting, pain under breastbone , tired unable to eat, has stayed in bed basically from the evening of 02/25/2021 through 03/05/2021.
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| 64 | 2021-03-05 | abdominal discomfort |
Patient received vaccine at 11:25 am. History of reaction to tetanus in past. Patient stayed to be o...
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Patient received vaccine at 11:25 am. History of reaction to tetanus in past. Patient stayed to be observed for 30 minutes. At approximately 11:40 am, patient c/o GI-upset; continued to observe. At approximately 11:50 am patient c/o left arm heaviness and numbness to fingers and pain up and down left arm. Paramedics were radioed at 11:53 am and arrived at 11:55 am to assess patient. Patient left with daughter in stable condition at 12:15 pm.
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| 64 | 2021-03-06 | abdominal distension, diarrhea |
Patient received her first Pfizer vaccine today at 12:24pm .She was sent to observation feeling wel...
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Patient received her first Pfizer vaccine today at 12:24pm .She was sent to observation feeling well. About 10 to15 minutes later she began to complain to her son that her head felt "bloated", her eyes felt heavy and her head felt hot. The nurse removed the patient to the nurses station and took her vital signs, then notified the clinical lead PN. The patient Initial vital signs taken at 13:15 were BP 157/85 P 78 , O2 sat 99%,. R 18. Denies Shortness of breath, difficulty breathing or swallowing. No skin color changes noted. No rash or pruritis. Denies chest pain, pressure or palpitations. Consumed a bottle of water without difficulty. About 20 minutes after the vaccine was received she began to feel faint, but did not feel as though she was "going to pass out" . VS remained stable; BP 157/85/P78.O2sat 99% She continued to c/o head fullness, but now was reporting feeling chills, and flushing . Son administered an extra strength Tylenol at 13:10. Nurse acted as interpreter as well as her son. Paramedics were called initially at 12:56 and again at 13:21 Patient was able to get up and walk to the bathroom with attendants , voided under observation and return to her chair without complaints of instability or dizziness. Paramedics arrived at 13:45. Vs were noted to be 160/90 , pulse 75, O2sat 99% Patient continued to complain of head and eye fullness and vertigo( Paramedic looked like her was swaying). Patient appeared stable ,in no acute distress when she was escorted out of the building ambulance by paramedics at 13:55 to be taken to a Hospital for evaluation.
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| 64 | 2021-03-06 | nausea |
This 64 year old female experienced an adverse event. At baseline, she presented in a wheelchair. Wi...
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This 64 year old female experienced an adverse event. At baseline, she presented in a wheelchair. Within 5 minutes after vaccination, she complained of a racing heart, a new onset tremor of hands and head, and slurred/stuttering speech. She denied chest pain, shortness of breath or itching. No facial droop or one-sided weakness was observed. The patient had a history of hypertension and history of an adverse reaction to albuterol in November 2020. The patient described being nervous to get the vaccine due to her previous reaction to alberterol which had the similar effects as today's. The patient's new tremor worsened, and speech became more slurred and stuttered while we observed her. The patient denied any pain and described a similar event that caused her to be hospitalized for a week with no definitive diagnosis. Her primary care doctor had cleared her to get the vaccine. Her Vitals were as follows: BP 160/90. HR 65, RR 20. Heart sounds were regular with occasional PVC's. Lung sounds were clear No visible rash on neck, trunk or injection site. Capillary refill was normal. Mild edema in both lower extremities. No swelling of the lips. No visible droop in facial muscles. Patient was tearful and struggled to speak. She repeatedly said she was tired. She reported nausea. EMT was called and found similar vitals and O2 saturation at 100% on room air by pulse ox. O2 via nasal canula was begun. Rhythm strip showed NSR. Patient refused transport to the hospital for further evaluation. She was informed of a possible Transient Ischemic Attack (TIA) could be occurring which could need a blood thinner and further work up. Patient was tearful saying her previous hospitalization was traumatic and did not want to return. EMS offered her transport to another hospital facility via private vehicle, and she refused. We offered to contact her primary care doctor and she also refused. She was concerned about the cost of a hospital stay if she signed out AMA. EMS left the facility and offered to return if the patient changed her mind. The patient's symptoms had not resolved by 4:30pm. The patient's son, by phone, confirmed she would be monitored until 5pm. She was driven home by one of our staffers. The next day, the patient told our staffer that she felt well. She said it took about 7 hours for her speech to return. She said her head, stomach and body felt better in the morning. She said she going to see an allergist as her doctor recommended. Our presumed diagnosis was a TIA related to uncontrolled HTN with anxiety.
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| 64 | 2021-03-07 | diarrhea, abdominal pain upper |
I was okay until after arriving home at which time I developed and headache and exhaustion. I went s...
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I was okay until after arriving home at which time I developed and headache and exhaustion. I went straight to bed for 2 days with headache, stomach pain, couldn't eat or drink. I started to feel a little better but still was unable to eat and was fatigued. When I did try to eat I got terrible diarrhea almost immediately. Over the next few days, realizing this was probably not normal, I contacted the advice nurse at my provider and eventually talk to a doctor on Friday (March 5). That doctor thought it sounded like I contracted COVID. I had a test that day that came back the next day negative. I have an appointment to talk to my regular doctor on Wednesday (March 10), particularly to get advise about whether to get the 2nd dose on March 20. My blood pressure has been unusually low (as low as 85/58) but is now about 120/60. I did not have a fever. My breathing has been more labored than usual, but my oxygen level is at 97% and my pulse is around 65.
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| 64 | 2021-03-07 | diarrhea, nausea |
Fever, headache, nauseous, diarrhea, body aches. took 800mg ibuprofen for fever, headache and body ...
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Fever, headache, nauseous, diarrhea, body aches. took 800mg ibuprofen for fever, headache and body aches. symptoms lasted about 30 hours.
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| 64 | 2021-03-07 | nausea, diarrhea |
Huge headache, high fever 103,and chills for two days then lowgrade for 36 hours, dizziness,severe m...
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Huge headache, high fever 103,and chills for two days then lowgrade for 36 hours, dizziness,severe muscle pains, extraordinary fatigue, diarrhea and nausea, swelling feet, weakness
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| 64 | 2021-03-07 | nausea |
Felt nauseated two hours after shot until the next day. Left arm had fever and swolen at injection ...
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Felt nauseated two hours after shot until the next day. Left arm had fever and swolen at injection site for six days. I'm feeling better now. I am frightened of getting the second shot. I had Covid in October and was quite ill. I don't want that feeling again. I was totally surprised by having an issue with first shot.
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| 64 | 2021-03-07 | nausea | Fever, weakness, nsusea, dizziness |
| 64 | 2021-03-07 | nausea |
Nausea and occasional shortness of breath. Started 6 hours after vaccine and I still have it. It's n...
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Nausea and occasional shortness of breath. Started 6 hours after vaccine and I still have it. It's not as bad but still here.
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| 64 | 2021-03-07 | nausea | Injection site very sore; Fatigued; headache; nausea |
| 64 | 2021-03-08 | decreased appetite |
One and a half hours after the vaccine, I suddenly became very dizzy and had a hard time focusing. ...
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One and a half hours after the vaccine, I suddenly became very dizzy and had a hard time focusing. I was extremely happy that I was NOT driving. I could not think straight and had sweat pouring down my face. My head was very heavy and as the day progressed, my neck also became sore. I took Advil and later Tylenol and they helped the head ache but not the dizziness. I lost appetite. I consulted the reading material about the vaccine and all of my symptoms were normal side effects, so I did not seek medical assistance. My daughter is a doctor and wanted me to report for statistical reasons.
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| 64 | 2021-03-08 | vomiting, nausea |
Evening of 3/8/21 severe dizziness, nausea, vomiting, weakness: lasted several hours then gradually ...
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Evening of 3/8/21 severe dizziness, nausea, vomiting, weakness: lasted several hours then gradually improved overnight
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| 64 | 2021-03-09 | abdominal pain, diarrhea | Abdominal cramping & diahhrea |
| 64 | 2021-03-09 | diarrhea | headache, diarrhea |
| 64 | 2021-03-09 | nausea |
reports that she starting having a flutter in right side of chest ( a little catch) and then went aw...
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reports that she starting having a flutter in right side of chest ( a little catch) and then went away on the drive home from receiving vaccine. then 5 hours later her teeth and nose began to hurt. Fatigue, headache, nausea, continued pain in nose and teeth over the weekend. seen NP on Monday and was prescribed allergy meds and was told that this is symptoms of the vaccine. she reports today that the right side of her face is swollen and that she feels like there is a boil in her nose.
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| 64 | 2021-03-09 | vomiting |
pt. had a potential COVID exposure at work prior to getting the COVID vaccine, she is experiencing s...
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pt. had a potential COVID exposure at work prior to getting the COVID vaccine, she is experiencing symptoms of vomiting, headache, muscle aches. I recommend you get tested for COVID just to rule out whether you have COVID or not, if test comes back positive you would have to wait till the symptoms subside prior to getting your second dose.
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| 64 | 2021-03-10 | nausea |
first dose - sore arm about 12 hours after injection lasting for approx 2 days. second dose - pressu...
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first dose - sore arm about 12 hours after injection lasting for approx 2 days. second dose - pressure in top of head about 17 hours after injection dissipated after about 4 hours after taking tylenol. second dose - nausea starting about 17 hours after injection and lasting approximately 20 hours. second dose - sore arm about 12 hours after injection very similar to sore are when you get flu shot
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| 64 | 2021-03-11 | constipation, abdominal pain upper |
Woke at 32hrs with severe pain in Rt hip joint and Rt knee joint. later in day rt leg was numb, unab...
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Woke at 32hrs with severe pain in Rt hip joint and Rt knee joint. later in day rt leg was numb, unable to bear weight, go up stairs without assist or sleep. Next day #3, severe pain in Rt hip, Rt knee and femur. Not responding to Motrin 800mg Q6-8hrs, Tylenol 1gm Q6-8 hours. Day #4 pain now radiating down rt leg through both joints and into Rt calf. Now Monday- called PCP, advised symptoms and would be starting perocets for 2 days of severe pain post vaccine. Also took ASA 325mg for blood clot risk know with virus even through pain was hip to ankle now (not ascending but descending) Percocet Q6hours without improvement but could sit and sleep with pain (dulled brain response to pain). Day #5- leg completely numb, pain now following sciatic nerve, stopped meds as no improvement and developed headaches, stomach aches and constipation from meds. Day#6 Pain severe in am, from hip to ankle- leg and heal of Rt foot numb. Today #7 pain on awaking, Rt hip all along sciatic nerve to foot which remains numb in heel.
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| 64 | 2021-03-11 | diarrhea, vomiting | 6 hours of Diarrhea, vomiting, flushing, headache, shaking. No fever |
| 64 | 2021-03-11 | gastrointestinal pain |
Starting Sunday after vaccine, patient started experiencing gut pain and immediately started a liqui...
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Starting Sunday after vaccine, patient started experiencing gut pain and immediately started a liquid diet. In spite of that it progressed. By Tuesday she was not able to walk upright. She went to urgent care and was sent immediately to ER for a CT to r/o possible perforation. Dx was Severe diverticulitis flare requiring antiemetic, pain medication, CT scan at ER antibiotics. She has had flares in the past, but it?s always due to diet and mild. This time she had been compliant with her diet for weeks or months.
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| 64 | 2021-03-12 | diarrhea, abdominal discomfort |
2-3 days prior to getting the vaccine, I was experiencing my typical Irritable Bowel symptoms (cramp...
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2-3 days prior to getting the vaccine, I was experiencing my typical Irritable Bowel symptoms (cramping while defecating ). Normally, if the cramping gets severe, I take one Hyosycamine Sulfate .0125 mg and the cramping stops within 10-15 minutes. The morning after the vaccine , starting at 6 am, I had severe cramping...took one Hyosycamine Sulfate pill and the severe cramping did not ease for 2.5 hours. I called my primary physician and she felt that this intensity/duration could have been connected to the vaccine. I was not producing any feces during this event, just severe episodic cramping. I also had the expected headache and chills. I felt stomach discomfort for the rest of the day. My doctor advised me taking the pill 3 times each day and two during an intense episode. I took one more pill at 2:45pm. I had another episode of severe cramping from 10:30-11:00pm , took two pills and then the cramping stopped and resolved in some diarrhea (two movements).
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| 64 | 2021-03-12 | diarrhea, decreased appetite, nausea |
Nausea, diarrhea, pounding headache, fever (101.6), extreme fatigue, sore joints, aches, loss of app...
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Nausea, diarrhea, pounding headache, fever (101.6), extreme fatigue, sore joints, aches, loss of appetite (3 days)....
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| 64 | 2021-03-12 | nausea | Chills, headache muscle aches all over, coughing, nausea. |
| 64 | 2021-03-12 | nausea |
12 hours after -- fever around 100 degrees F, chills, headache, body aches, nausea - cleared in a d...
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12 hours after -- fever around 100 degrees F, chills, headache, body aches, nausea - cleared in a day. Sore at site of shot. 6 days after - still sore at site, but now red, rash, intense itching, swollen, and swollen lymph nodes under arm at the site of shot. This continues 5 days later despite treating with Benadryl and Aleve and topically with hydrocortisone cream.
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| 64 | 2021-03-14 | diarrhea |
dehydration; slight fever (99); chills; passed out in floor; sweating; Broke a tooth; Dizzy; Diarrhe...
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dehydration; slight fever (99); chills; passed out in floor; sweating; Broke a tooth; Dizzy; Diarrhea; Super tired and went to bed by 8pm after COVID-19 vaccine; Arm was sore; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 24Feb2021 at 15:00, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none. Patient did not have known allergies. Patient did not receive any other vaccine the same day and in four weeks. Patient did not have COVID-19 prior to vaccination. The patient experienced passed out in floor (medically significant) on 24Feb2021 at 10:30 PM, diarrhea (disability) on 24Feb2021, broke a tooth (medically significant) on 24Feb2021 at 10:30 PM, dehydration (disability) on 25Feb2021 12:00 AM, slight fever (99) (disability) on 25Feb2021 at 12:00 AM, chills (disability) on 24Feb2021 at 10:30 PM, super tired and went to bed by 08:00 PM after COVID-19 vaccine (non-serious) on 24Feb2021, arm was sore (non-serious) on 24Feb2021, sweating (non-serious) on 24Feb2021 at 10:30 PM, dizzy (non-serious) on 24Feb2021. No therapeutic measures were taken as a result of the events. Patient stated that all side effects resolved completely by 25Feb2021 evening, except for broke a tooth. Patient did not tested positive for COVID-19 post vaccination. The information on the Lot/Batch number has been requested.
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| 64 | 2021-03-14 | nausea, diarrhea |
Thursday fever, diarrhea, nausea, body aches, Friday fever, headache, diarrhea, Saturday fever and d...
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Thursday fever, diarrhea, nausea, body aches, Friday fever, headache, diarrhea, Saturday fever and diarrhea, Sunday diarrhea
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| 64 | 2021-03-14 | nausea, difficulty swallowing |
The NEXT day: chills, headache, heavy nausea, dry cotton mouth, but couldn't drink. Dizzy. Couldn't...
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The NEXT day: chills, headache, heavy nausea, dry cotton mouth, but couldn't drink. Dizzy. Couldn't barely lift legs to walk. No bladder control. Hard to get to bathroom. Fell twice. Second time hitting head. Then, Difficulty breathing. And heart racing. (Please note: I did actually have Covid last summer from July through August).
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| 64 | 2021-03-14 | nausea |
had flush feeling (much like injection during CT scan); Within hour my ears felt hot and turned brig...
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had flush feeling (much like injection during CT scan); Within hour my ears felt hot and turned bright red Subsided within hour.; Ate supper, Went to bed, upon waking in nite experienced imbalance; vertigo; Neck pain; headache; nausea; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female non-pregnant patient received first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264, Solution for injection), via an unspecified route of administration in the left arm on 29Jan2021 (at the age of 64-years-old) as a single dose for COVID-19 vaccination. Medical history included CAD (coronary artery disease), Irregular heart rhythm, BPPV, degenerative disc disease, anxiety, ptsd (post-traumatic stress disorder), pre diabetic, Allergies to food, chemical and sensitivities and med and sensitivites. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccine within 4 weeks prior to the vaccine. Concomitant medications were not reported. Upon receiving injection, on 30Jan2021, patient had flush feeling (much like injection during CT scan). Within hour her ears felt hot and turned bright red Subsided within hour. After supper, went to bed, upon waking in night experienced imbalance. Laying back down experieced vertigo (what she thought was a BPPV episode, a prior cond) but she couldnt figure out which side to treat, she performed maneuver. But did not resolve. She was remaining off balance and spinny even being upright with movement of head or eyes. Neck pain and headache residual nausea. About 12 hours after injection. Upside, her arm doesnt hurt. The patient did not receive any treatment for the events. No seriousness criteria was reported. The patient underwent lab tests and procedures which included computerised tomogram and results are unknown. The outcome of events was unknown.
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| 64 | 2021-03-14 | nausea | Soreness at injection site, chills, headache, nausea, tiredness |
| 64 | 2021-03-14 | nausea |
3-9-21 6:40PM 'SHARP PAIN IN CHEST X2MIN'. 'ALSO NAUSEA AND FEELS DRUNK'. NO SOB/DYSPNEA. 7:16PM P...
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3-9-21 6:40PM 'SHARP PAIN IN CHEST X2MIN'. 'ALSO NAUSEA AND FEELS DRUNK'. NO SOB/DYSPNEA. 7:16PM PLACED IN W/C TAKEN TO MEDIC TENT & PLAACED ON CARDIAC MONITOR: NSR NOTED. 7:25PM STATES 'DECREASED NAUSE AND NO CHEST APIN NOW - STILL FEELS DRUNK'. PT DECLINES JUICE AND CRACKERS - STATES SHE WANTS TO WAIT AND TAKE HER DIABETIC MEDS BEFORE SHE EATS'. 7:30PM 'FEELING BETTER' TO EXIT PER W/C TO BE DRIVEN HOME PER DAUGHTER. 3-12-21 1PM TC: STATES 'NO CHEST PAIN , STILL HAS A LITTLE NAUSEA'.
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| 64 | 2021-03-15 | nausea |
Admitted to hospital- Acute severe progressive hypoxic respiratory failure- intubated, trach placed,...
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Admitted to hospital- Acute severe progressive hypoxic respiratory failure- intubated, trach placed, COVID-19 pneumonia, Afib Patient treated at primary care office 01/13/2021 for respiratory illness (tested negative for COVID at this time), had vaccine 01/20/2021, developed headache and tested positive COVID-19 the following day 01/21/2021. Symptoms worsened with nausea and shortness of breath. Patient admitted 01/29/2021, condition progressed- intubated 02/07/2021, trach placed 02/25/2021.Discharged to specialty hospital 03/12/2021 for continued respiratory support and rehabilitation
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| 64 | 2021-03-16 | abdominal pain upper |
EXTREME post-nasal drip event resulting in extended choking. Throat did not close, but it happened l...
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EXTREME post-nasal drip event resulting in extended choking. Throat did not close, but it happened less than 10 minutes post vaccine. On site staff was prepared with epi-pen, which I also had with me, but wasn?t needed. Only needed water and many tissues, and on site staff said it was not a reaction. But as it was so sudden, extreme, and immediately following the vaccine, Dr. at Clinic said he felt it was indeed a reaction. It cleared up in about an hour. Other side effects were mild (fatigue, head ache, achÃness, stomach ache) and were gone in two days.
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| 64 | 2021-03-16 | diarrhea, nausea |
With in 5 minutes of the shot my chest and left arm pain and heart started to race,,face turned rash...
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With in 5 minutes of the shot my chest and left arm pain and heart started to race,,face turned rashy red and hot, had the shakes, nauseous dizzy and short of breath, blood pressure was high, with in hour my heart rate started to slow down, I took a Benadryl, felt ill. Tuesday started having diarrhea then around 11:30 pm had same reactions as Monday after shot was given. Took another Benadryl. Wednesday still bouts of diarrhea, tired,weak.nauseous.
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| 64 | 2021-03-17 | constipation, nausea |
Tiredness - couple of days; Headache - day; Chills - day; Fever - few hours; Nausea - few hours; Cou...
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Tiredness - couple of days; Headache - day; Chills - day; Fever - few hours; Nausea - few hours; Couldn't pee or have a bowel movement - few hours
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| 64 | 2021-03-18 | decreased appetite, nausea |
Feeling unwell; All over upper body itchiness/she itches all over; Fatigue/feeling very tired/little...
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Feeling unwell; All over upper body itchiness/she itches all over; Fatigue/feeling very tired/little fatigue; Severe arm/injection site pain; Severe arm/injection site pain/very sore arm; Chills; Low grade fever; Headache; Lightheaded; Weakness/really weak; Itchy rash on chest/has a rash on her chest/little rash on my back; Nausea; Loss of appetite; She is flushed; tested positive for Covid and 6 days; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received first dose of BNT162B2 (Solution for injection, Batch/Lot: EL9265) in right arm via an unspecified route of administration on 08Feb2021 07:45 at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included osteoporosis, Inappropriate sinus tachycardia, known allergies. Concomitant medication included estradiol benzoate (ESTRADIOL [ESTRADIOL BENZOATE]), calcium (CALCIUM), ergocalciferol (VITAMIN D [ERGOCALCIFEROL]), naproxen (NAPROXEN), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) all at once a day. The patient was not diagnosed with covid-19 before vaccination and covid was not tested post vaccination. The patient had the first vaccine on 08Feb (complete date not clarified), two days after that it had most of the side effects, with the one very sore arm, headache, fever chills, nausea, feeling very tired, about 6 days after that she tested positive for Covid and 6 days after the first vaccine. She tested positive for Covid so for the last couple of weeks. She had Covid, the fever broke about 5 to 6 days ago, she had a low grade fever after that, also the symptoms were gone now, there was little fatigue and little rash on back. She was scheduled to take second shot now and was trying to find in research about taking the second shot inspite of having covid. She cant find anything, most of the people never heard this and primary care physician said to go ahead and take the shot, but some people and some researchers said you should not, because she might have symptoms later and she should wait. The treatment was not received for the adverse events. Outcome of tested positive for Covid and 6 days was unknown and for other events it was recovering.
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| 64 | 2021-03-18 | nausea, decreased appetite |
extreme congestion; Loss of appetite; nausea; fever; chills; headache; fatigue; dry cough; injection...
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extreme congestion; Loss of appetite; nausea; fever; chills; headache; fatigue; dry cough; injection site pain; pain; This is a spontaneous report from a contactable consumer (patient). A 64-year-old non-pregnant female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201, Expiry date: unknown), via an unspecified route of administration on 09Feb2021 at 03:00 PM (at the age of 64-year-old) on Left arm at single dose for covid-19 immunisation. The patient's medical history was not reported. Patient had unspecified other medications in two weeks. The patient previously took first dose of BNT162B2 (Lot number: EL9262) on 22Jan2021 at 02:30 PM on Left arm at single dose for covid-19 immunisation and had vancomycin and experienced drug allergy. The patient experienced Loss of appetite, nausea, fever, chills, headache, fatigue, dry cough, extreme congestion, pain at injection site and aches on 10Feb2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The patient was recovering from the events. No follow-up attempts are possible. No further information is expected.
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| 64 | 2021-03-18 | nausea, vomiting |
Most severe headache ever Fever and chills Extreme fatigue Nausea and Vomitting 10xs Joint and muscl...
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Most severe headache ever Fever and chills Extreme fatigue Nausea and Vomitting 10xs Joint and muscle ache
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| 64 | 2021-03-18 | nausea |
2:30 am uncontrollable shaking, chills, lasted 3 hours. All next day fever 102, body aches, fatigu...
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2:30 am uncontrollable shaking, chills, lasted 3 hours. All next day fever 102, body aches, fatigue, nausea, last 20 hours.
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| 64 | 2021-03-19 | decreased appetite, nausea |
Ten hours after the shot I experienced chills for over 2 hours, followed up with fever, headache, na...
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Ten hours after the shot I experienced chills for over 2 hours, followed up with fever, headache, nausea, extremely tired, no appetite. Felt pretty much back to normal the second day after the shot.
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| 64 | 2021-03-19 | nausea, diarrhea |
About an hour after receiving the vaccine I started getting pins and needles in my face/jaw. About ...
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About an hour after receiving the vaccine I started getting pins and needles in my face/jaw. About 2 hours later my blood pressure was high - 150/90 (checked on a home monitoring machine) and then I started with heart palpitations which lasted throughout the night - did not sleep more than an hour or two. Next day around noon had diarrhea a few times - tired and weak. Slight headache for about 4 days. Nausea for about 3 or 4 days.
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| 64 | 2021-03-19 | nausea | Severe headache and nausea |
| 64 | 2021-03-19 | nausea |
I woke up on the second day after first dose (not the very next day) and my face was swollen and eye...
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I woke up on the second day after first dose (not the very next day) and my face was swollen and eyes swollen, Right eye swelling more prevalent. I itched all over at various times and took Benadryl for 3-4 days. I also had slight headache, nausea, malaise.
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| 64 | 2021-03-20 | abdominal discomfort |
Pain at injection site Chills Achiness Fatigue Stomach discomfort About 4 hours after injection, g...
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Pain at injection site Chills Achiness Fatigue Stomach discomfort About 4 hours after injection, getting better the next evening, now feeling some fatigue. Slight pain at injection site. Took Tylenol.
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| 64 | 2021-03-20 | abdominal pain upper |
post injection: 8 minutes-heart pounding so strong I could hear it, continued for 5 or 6 minutes 8 m...
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post injection: 8 minutes-heart pounding so strong I could hear it, continued for 5 or 6 minutes 8 minutes-slight drop in blood pressure (I've gone as low as 32/18 during a bad reaction so I know this time was a much smaller drop) 13 minutes-stomach pains started, these would continue throughout the night waking me, and lasted approximately 17 hours 30 minutes- sudden feeling of lightness in my body, and that a light had gone on 60 minutes-odd sensations in throat but did not feel swelling, simultaneously at 60 minutes-dizzy the next day, 10 bowel movements until 2 pm
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| 64 | 2021-03-20 | decreased appetite, abdominal pain upper, vomiting |
3/18/2021 9:00am Vaccine administered Around 2:00 pm Chills and stomach pain Around 3:00 pm 101.2 Fe...
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3/18/2021 9:00am Vaccine administered Around 2:00 pm Chills and stomach pain Around 3:00 pm 101.2 Fever, chills, worsening stomach pain, vomiting, light headed Around 5:00 pm went to ER on advisement of Doctors office While in ER experienced more vomiting, fever chill, stomach pain ER administered IV fluids, Tylenol, blood draw 10:00 pm Released from ER and went home 3/19/2021 No appetite, extreme fatigue, some dizziness, slight headache, chills in evening 3/20/2021 Very little appetite fatigued, some dizziness, backache Around 5 pm stomach pain which subsided an hour later, 6:00pm chills
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| 64 | 2021-03-20 | nausea, vomiting, diarrhea |
Chills; severe diarrhea; vomiting; nausea; dizziness; This is a spontaneous report from a contactabl...
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Chills; severe diarrhea; vomiting; nausea; dizziness; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (solution for injection, Lot number: EK9231), administered in left arm via an unspecified route of administration on 03Feb2021 at single dose for covid-19 immunisation. Medical history included High blood pressure, strabismus, known allergies Sulfa antibiotics, quinolone antibiotics. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination. Historical vaccine included BNT162B2 First dose: lot EJ1686, expiry Mar2021, 0.3ml single dose by injection once to left arm for covid-19 immunisation. Concomitant medications included Atorvastatin 20mg, amlodipine-benazepril 2.5-10 taken for an unspecified indication. The patient experienced chills, severe diarrhea, vomiting, nausea, dizziness on 03Feb2021 23:00. The outcome of the events was recovering. Treatment received for the adverse events as nausea medication. Follow-up activities are completed. No further information is expected.
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| 64 | 2021-03-21 | diarrhea | Diarrhea, watery stool, edema left hand, my algae, arthralgia of both hands |
| 64 | 2021-03-21 | nausea | Fever. Chills. Nauseous, joint pain, headache Until approx 10 pm sunday night Ok on 3/22/21 |
| 64 | 2021-03-21 | vomiting, nausea |
Bad headache; nausea; vomiting; This is a spontaneous report from a contactable consumer. A 64-year-...
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Bad headache; nausea; vomiting; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 17Feb2021 13:15 (Batch/Lot Number: EN6200) as SINGLE DOSE for covid-19 immunisation. Medical history included diabetes mellitus, asthma, and GERD. Concomitant medications included alprazolam; omeprazole; sitagliptin (JANUVIA [SITAGLIPTIN]); all taken for unspecified indications, start and stop dates were not reported. The patient previously took flagyl [metronidazole]: Known allergies: Flagyll. On 18Feb2021, the patient experienced bad headache, nausea, and vomiting. The patient did not receive treatment for the events. The outcome of the events was not recovered.
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| 64 | 2021-03-22 | flatulence, diarrhea, abdominal pain, abdominal distension |
diarrhea; excessive gas; bloating; abdominal pain; This is a spontaneous report from a contactable n...
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diarrhea; excessive gas; bloating; abdominal pain; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EH9899), via an unspecified route of administration in the left arm, on 26Dec2020 at 12:00 (at the age of 64-years-old) at a single dose for COVID-19 immunisation. Medical history included Hashimoto's, hypertension, osteoporosis, and sulfa allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included unspecified medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took methocarbamol (ROBAXIN) and experienced allergy. The patient experienced diarrhea, excessive gas, bloating, and abdominal pain on 27Dec2020 at 01:00. It was reported that the patient had diarrhea during the night after receiving the vaccine, which has not stopped, and also had excessive gas, bloating and abdominal pain as well. The patient underwent lab tests and procedures, all on an unspecified date, which included lab work: unknown results, stool testing: unknown results, and abdominal ultrasound: unknown results. Therapeutic measures were taken as a result of all of the events, which included unspecified treatment. The clinical outcome of diarrhea, excessive gas, bloating, and abdominal pain was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 64 | 2021-03-22 | nausea, abdominal pain upper |
dizzy; Then I passed out; Headache; Nausea; Arm soreness 2 hours after injection.; Chills for well o...
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dizzy; Then I passed out; Headache; Nausea; Arm soreness 2 hours after injection.; Chills for well over 12 hours; stomach pain; big bump on my head where I hit the tile floor; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received the first dose of bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6206), via an unspecified route of administration, administered in the left arm on 05Mar2021, 16:30 as a single dose for covid-19 immunisation. The patient's medical history included allergies to Sulfa based meds from an unknown date and unknown if ongoing. The patient had Covid prior to vaccination. Concomitant medications included cranberry; colecalciferol (D3), fish oil, and multi-vitamin taken for an unspecified indication, start and stop date were not reported. On 05Mar2021 at 18:30, the patient experienced headache, nausea, arm soreness 2 hours after injection. Chills for well over 12 hours. Most concerning, patient got up in the middle of the night. Used facilities. Washed hands, and was having stomach pain. Then she passed out. she came to, and have a big bump on her head where she hit the tile floor. Sunday Morning (07Mar2021) she was dizzy. Maybe from the bump on her head. The patient did not received treatment for the events. The outcome of the events was recovering at the time of the report. The has not tested positive for Covid-19 post vaccination.
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| 64 | 2021-03-23 | nausea |
Recieved second Pfizer injection (was Covid symptom free for 5 days) at 10 am. AT 3 am awoke with c...
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Recieved second Pfizer injection (was Covid symptom free for 5 days) at 10 am. AT 3 am awoke with chills and 102.5 fever, nausea and followed by sweats. This has continued thru 3/23/21, so far. On 3/23/21 fever maintained between 100 & 100.8. Still felt badly. Awoke this am 3/24/21, sweaty but no fever thus far. Feeling better.
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| 64 | 2021-03-23 | nausea |
Light headed, dizzy,neck pain, tiredness, blood pressure high, nausea Thought I was having a heart...
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Light headed, dizzy,neck pain, tiredness, blood pressure high, nausea Thought I was having a heart attack.
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| 64 | 2021-03-23 | nausea | Nausea, Overall body unwell, now a week later, a sore lump in armpit on vaccination arm. |
| 64 | 2021-03-23 | nausea | Chills nausea bad headache extreme fatigue aches pains |
| 64 | 2021-03-24 | difficulty swallowing |
Patient c/o tightness of throat. She states it is not closing but has a tighten feeling following ...
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Patient c/o tightness of throat. She states it is not closing but has a tighten feeling following with swallowing issues . Admin 50 mg Benadryl by mouth. Advised to f/u with PCP and report to ER. Patient verbalizes understanding.
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| 64 | 2021-03-24 | nausea |
Chills then headache and extreme nausea. These all occurred beginning about 10 hours following my fi...
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Chills then headache and extreme nausea. These all occurred beginning about 10 hours following my first dose of Covid-19 vaccination.
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| 64 | 2021-03-24 | nausea |
tiredness; Headache; muscle pain; chills; joint pain; nausea; feeling unwell; This is a spontaneous ...
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tiredness; Headache; muscle pain; chills; joint pain; nausea; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 64-year-old non-pregnant female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 13Feb2021 at 14:00 (at the age of 64-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history was reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. Concomitant medications were not reported. The patient did not receive any other medications in two weeks. The patient did not receive other vaccines within 4 weeks prior to vaccination. On 13Feb2021 at 22:00, the patient experienced tiredness, headache, muscle pain, chills, joint pain, nausea, and feeling unwell. Therapeutic measures were not given for the events. The clinical outcome of the events tiredness, headache, muscle pain, chills, joint pain, nausea, and feeling unwell was not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 64 | 2021-03-24 | nausea |
Patient stated she felt some chest heaviness and some mild shortness of breath 5 minutes after recei...
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Patient stated she felt some chest heaviness and some mild shortness of breath 5 minutes after receiving her vaccine. She also claimed she was light headed and had a wave of nausea right after her vaccine. She said she has never had a vaccine reaction like this before and claims she ate breakfast this morning. Upon our interview, her symptoms decreased. She denied any swelling, trouble speaking, drooling. We added 10 minutes on to her observation time and after that she was ready to go. When pt left, she did not have any chest tightness or SOB.
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| 64 | 2021-03-24 | vomiting, nausea |
24 hours after receiving shot I experienced severe vomiting that occurred every 20 mins for the firs...
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24 hours after receiving shot I experienced severe vomiting that occurred every 20 mins for the first 12 hours..every hour for the 2nd 12 hours and every couple of hours for the third set of 12 hours for a total of 36 hours. Unable to hold down even a drink of water. I suffer from migraines and had one during a 3 day span from Sunday until Tuesday evening 9 pm. Now a full 4 days from the vaccine I still have nausea and extreme fatigue.
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| 64 | 2021-03-25 | diarrhea, nausea, vomiting |
Arm pain at injection site, Severe Nausea with vomiting and diaherrea, mild shortness of breath, ext...
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Arm pain at injection site, Severe Nausea with vomiting and diaherrea, mild shortness of breath, extreme fatigue
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| 64 | 2021-03-25 | diarrhea, vomiting, nausea |
Patient states that about 12 hours following her 1st dose of this vaccine she began to experience si...
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Patient states that about 12 hours following her 1st dose of this vaccine she began to experience side effects including nausea, diarrhea, vomiting, and a headache. Patient states that these effects lasted throughout most of the following day and then began to dissipate .
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| 64 | 2021-03-25 | nausea, vomiting, diarrhea |
Nausea, vomiting and diarrhea (2 days) Dizziness and lightheadedness (2 days) Vertigo (has been 10 d...
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Nausea, vomiting and diarrhea (2 days) Dizziness and lightheadedness (2 days) Vertigo (has been 10 days and is currently happening) Ringing in the ears Brain fog (5 days) Symptoms are ongoing and have decreased only slightly as of this report
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| 64 | 2021-03-25 | nausea | Tachycardia body was on fire high bp shaking Nausea feeling of impending doom headache |
| 64 | 2021-03-26 | nausea |
6 days after 1st shot - woke up to severe veritgo (spinning) ,, dizzy,sweating , nauseous, lasted 2 ...
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6 days after 1st shot - woke up to severe veritgo (spinning) ,, dizzy,sweating , nauseous, lasted 2 1/2 full days . tingling of hairline and under the eyes, eyes were blurry for two days, starting getting heart palpatations, and blood pressure high and resting heart rate low and other times blood pressure was real low and resting heart rate as high as 125 even at rest not due to exercise... this continued with the heart irregularaties for abour two weeks. . i experienced unusal forgetfulness and couldnt recall things I knew .. i had mild fatigue... 3 weeks later Im about 90 percent but a little sluggish. finally was able to do yoga(bending over ) weights,,walking,etc.
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| 64 | 2021-03-27 | diarrhea | Violent trembling from chills (3 hours), high fever (16 hours), diarrhea, vertigo, migraine |
| 64 | 2021-03-27 | nausea |
12:00 noon, began to feel nauseous, achy, scratchy eyes. Afebrile. ?Woozy? feeling increased. Un...
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12:00 noon, began to feel nauseous, achy, scratchy eyes. Afebrile. ?Woozy? feeling increased. Uncomfortable to read, watch TV. Slept x 1-2 hours. Symptoms subsided minimally while lying down. Increased upon standing. Could not eat. 9:00 pm, s/sx started to subside. Was able to eat some soup. By 10:00, felt relatively normal, but symptoms minimally returned upon standing. 8:00 next day, feeling normal
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| 64 | 2021-03-27 | nausea |
Felt no systems on the first shot, on the second shot on 3/24 I felt dizzy and nausea when first out...
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Felt no systems on the first shot, on the second shot on 3/24 I felt dizzy and nausea when first out of bed the following day, went back to bed for 2 hours, got up had coffee and toast, back to bed for another 2 hours, felt better but head ache and muscle aches over entire body, and fatigue. Had better strength at times through out day. Went to bed and woke up Friday and felt fine.
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| 64 | 2021-03-27 | vomiting | Vomiting, cramps, Fever 101.2, Chills, headache still experiencing |
| 64 | 2021-03-27 | vomiting | 24 hours after vaccine. Started vomiting for 5 hours, headache |
| 64 | 2021-03-28 | difficulty swallowing |
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specif...
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Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium
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| 64 | 2021-03-28 | nausea |
Approximately 5 mins after receiving the 2nd dose of Pfizer COVID-19, patient reported she begin to ...
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Approximately 5 mins after receiving the 2nd dose of Pfizer COVID-19, patient reported she begin to feel faint and dizzy. She also reported feeling nausea. Patient was alter and oriented, no difficulty breathing. Vitals were taken, patient's O2 was 98, pulse 56, and BP 90 by palpitation. Second BP taken 5 minutes later, BP raised to 118 by palpitation. Patient sipped on water, was laid back in the car, and windows rolled down. Patient reported she mitral valve prolapse and when she gets anxious, she starts to feel faint. Patient continued to be alert and oriented and within 15 minutes after first feeling faint, she stated she was feeling better. Was able to walk from driver to the passenger side of the car, patient reported she felt better and vitals were normal.
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| 64 | 2021-03-29 | abdominal pain, nausea |
Approximately 7 hours after receiving vaccine, I experienced severe abdominal pain. Treated with 2,...
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Approximately 7 hours after receiving vaccine, I experienced severe abdominal pain. Treated with 2, 500mg Tylenol, laid down, walked around to no avail. Thought it might be gas pain, took 2 Tums to no avail. Abdominal pain was increasing, was nauseous. Thought I might be experiencing a heart attack. 3/14/21Proceeded to the Hospital ER. Arrived at 9pm, was in ER until 4:30am, after CT Scan with dye and Ultrasound of gallbladder was admitted. Monday, 3/15/21 had a HIDA scan/exam, was scheduled for surgery to laparoscopically remove my gallbladder at 1pm Tuesday 3/16/21.
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| 64 | 2021-03-30 | diarrhea, flatulence, abdominal distension |
Gas; bloating; diarrhea; This is a spontaneous report from a contactable consumer or other non hcp (...
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Gas; bloating; diarrhea; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number:EN5318, batch and expiration date not reported), via an unspecified route of administration, administered on the left arm on 27Jan2021 08:30 (at the age of 64-years-old) at a single dose for COVID-19 immunisation. Medical history included high cholesterol and overweight. Concomitant medications included duloxetine hydrochloride (CYMBALTA), atorvastatin (manufacturer unknown), trazodone (manufacturer unknown), hydroxychloroquine (manufacturer unknown) all taken for an unspecified indication. The patient previously took sulfamethoxazole and trimethoprim (BACTRIM DS) and experienced drug hypersensitivity. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient experienced gas, bloating, and diarrhea on 27Jan2021 20:00. Events were assessed as non-serious. Treatment was not received for the events. The outcome of the events reported was recovered on an unspecified date.
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| 64 | 2021-03-30 | gastrointestinal disorder, diarrhea |
head and ears were itchy; but she has gastrointestinal issues; A little bit of erythema; diarrhea; O...
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head and ears were itchy; but she has gastrointestinal issues; A little bit of erythema; diarrhea; On her neck she had hives up to her face and down her chest a little bit/urticaria eye lid; rash on neck up to her face; rash on shoulder that she had injection in; This is a spontaneous report from a contactable other hcp (nurse). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6206), via intramuscular route of administration, in the right arm on 05Mar2021 09:30 (at the age of 64-years-old) as single dose for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis, anaemia, cardiac disorder, rash (She has had a reaction to IVP dye. She has to pre-medicate with benadryl and a steroid 10 hours before, then 8 hours before, then 1 hour before procedure prior to receiving IVP dye. When querying NDC/Lot/Expiry for IVP dye, caller states she does not have that information, it happened years ago. She always pre-medicates when she has to have have x-rays with the dye). The patient did not have history of all previous immunization with the BNT162B2 vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). Concomitant medications included tofacitinib citrate (XELJANZ XR) via oral route of administration from an unspecified date (been on for 2 years) and ongoing at a dose of 11 mg daily for rheumatoid arthritis; ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) for an unspecified indication; tramadol (TRAMADOL) via unspecified route of administration from an unspecified date and ongoing at a dose of 50 mg daily (in morning) for rheumatoid arthritis; gabapentin (NEURONTIN) via unspecified route of administration from an unspecified date and ongoing at a dose of 300 mg twice daily for rheumatoid arthritis and Multivitamin for an unspecified indication. The patient previously took buprenex and experienced drug hypersensitivity, buprenex and experienced nausea and vomiting, avelox and experienced angioedema. The patient did not underwent any Lab tests.The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than BNT162B2 Vaccine prior to the event being reported.The patient did not received any other vaccines around the time of BNT162B2 vaccination. She was calling about the Covid vaccine. She had her first dose this past Friday, clarified 05Mar2021. It's been a week. On the evening about 8 hours after the Covid 19 injection she got a rash on her shoulder that she had the shot in. The rash went across her chest to the other shoulder. On her neck she had hives up to her face and down her chest a little bit. She has been taking Benadryl for the past 6 days. She is very concerned what is going to happen with the next dose. She contacted her primary health care provider and it was recommended that the caller pre-medicate. The caller states it says not to pre-medicate. She has her next Covid 19 vaccine in 2 weeks and she was nervous. She did file a report with the government. It was in the information she received from the hospital where she got her Covid 19 injection. Every day at 2:00PM she gets a text message. They monitor her for up to a year. Every day she checks in and says how she feels, is she having trouble completing daily activities, did you have to call your doctor. They gave her a paper at the hospital where she had it done. When querying if this government program had given her a report number she states she doesn't have a report number, she deletes the text messages every day. She is due for the second Covid vaccine on 26Mar2021. It was reported that several hours after the injection in the evening, maybe 8 hours after she had the injection is when her symptoms began. She does feel like she is improving. Today was the first morning that she didn't take the Benadryl. She had no respiratory problems. But she was very concerned because the hives were pretty prevalent. It was very uncomfortable. She was taking 50mg of Benadryl for 5 days. When she went to the pharmacy to pick up a cream too, the pharmacist thought that a steroid would be good. She was concerned. She emailed her primary care doctor with pictures. When querying seriousness of events, caller states it was bad enough that she went to the pharmacy and called her primary care doctor and sent her pictures. If she had developed any respiratory issues she would have gone to the emergency room. If she was non medical she would have gone to the emergency room but because she's a nurse she thought she would ride it out. When querying information for the Pfizer Covid 19 Vaccine data capture aid, the caller reports the hives were 48 hours later. She also reports urticaria, her head and ears were itchy. She is using steroid cream on it. It is driving her crazy today. Still going to be using the cream. A little bit of erythema, worst part was her neck. When querying red and itchy eyes, she reports only the eyelid. When querying gastrointestinal issues, she reports she has diarrhea, but she has gastrointestinal issues. The diarrhea is nothing worse than what she normally has. She doesn't think this has anything to do with the vaccine. The patient did not visited to emergency room and physician office. The patient was not hospitalized or admitted to an intensive care unit. Therapeutic measure were taken with Benadryl 25-50mg (Lot Number:P134952, Expiration date: Sep2021) and Hydrocortisone cream 1% maximum strength for the events. It was reported that Benadryl makes her hyper and her heart racey.The outcome of the event diarrhea, gastrointestinal issues were repoorted as unknown, event head and ears were itchy was not recovered and recovering for other events. The events rash on shoulder that she had injection in, hives on neck, rash on neck up to her face were assessed as serious (medically Significant) by the reporter. The causality of the events rash on shoulder that she had injection, hives on neck, rash on neck up to her face were reported as related to vaccine.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 64 | 2021-03-30 | vomiting, diarrhea |
Chills; Vomiting; Diarrhea; shakes; Shortness of breath; Coughing; respiratory distress; This is a s...
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Chills; Vomiting; Diarrhea; shakes; Shortness of breath; Coughing; respiratory distress; This is a spontaneous report from a contactable retired nurse. A 64-year-old female patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EN6198; expiration date: unknown), at vaccination age 64-year-old via an unspecified route of administration in the right arm on 13Mar2021 09:30 as a single dose for covid-19 immunisation. The patient medical history was none. There were no concomitant medications. The patient reported that she had side effects after getting her first dose of the Pfizer COVID-19 vaccine Saturday morning (13Mar2021) at 09:30am. She mentioned that she developed side effects Monday (15Mar2021) night that she also had all day Tuesday (16Mar2021), it was pretty significant. She mentioned that she is concerned about getting the second dose, and she is thinking that she is not going to get that after having her first dose. She stated that her side effects lasted all night Monday night, she had shortness of breath and coughing. She added that on Tuesday morning she started having chills, shakes, throwing up or vomiting, and having massive diarrhea all day long. She also mentioned that she thought it was serious, and she was going to have to go to the hospital soon. She wasn't going to have a choice if it hadn't gotten better. She reported that all her side effects are better, and that for treatment, she took some Delsym cough medicine and diarrhea medicine, Imodium, she thinks it was called. She says she took one dose of the cough medicine yesterday morning, and she has taken 3 doses of Imodium today. She wondered if she should take the second shot or if she would get the same symptoms again. She says she is hesitant to take second one because she doesn't want respiratory distress again (Mar2021), it was horrible, and she has never had massive diarrhea before to where she couldn't get to the bathroom, it was the worst thing she has went through. The outcome of the events was recovering.; Sender's Comments: The contributory role of the suspect productbnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EN6198; expiration date: unknown), to reported events is possible.
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| 64 | 2021-03-31 | nausea |
At work suddenly became dizzy drunk feeling with I went on FLMA. nausea. Unsteady on my feet. felt a...
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At work suddenly became dizzy drunk feeling with I went on FLMA. nausea. Unsteady on my feet. felt as if my heart was vibrating. I am sure later I had a TIA. Was unable to communicate. I knew what I wanted to say but I could not get the words out. March 1/2021 I went on FLMA. It never dawned on me the vaccine could have affected my already stressed heart. I am still experiencing these symptoms. I just thought of this this week. I still have extreme fatigue, increased palpitations, and increased SOB. I do not feel able to work right now.
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| 64 | 2021-04-01 | diarrhea, abdominal pain upper, nausea, vomiting |
She said that she has a pretty swollen black eye that is really red too; She said that she has a pre...
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She said that she has a pretty swollen black eye that is really red too; She said that she has a pretty swollen black eye that is really red too; She said that she has a pretty swollen black eye that is really red too; Blacked out; severe stomach cramps; Nausea; Diarrhea; Vomiting; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 18Mar2021 at 09:55 (Lot Number: ER2613, unknown expiration) as a single dose for COVID-19 vaccination. Medical history and concomitant medications reported as none. The patient received the first shot of COVID-19 vaccine in the morning of 18Mar2021, and after supper, she experienced severe stomach cramps, nausea, diarrhea, vomiting, and stated that she blacked out. She mentioned that she is just taking it slow and eating broth. She confirmed that blacking out has only happened to her 2 other times in her life. She said that it usually happens with the cramping and the vomiting in this same kind of situation. She plans to follow up with the physician. She said that she has a pretty swollen black eye that is really red too (unspecified date). She is putting ice on it. It did not seem like she ate anything that would cause this reaction. She has no other reason to think her reaction could have been caused by anything else. She called the pharmacist and they told her to report it to Pfizer. No additional vaccines administered on the same date of COVID-19 vaccine. No prior vaccinations within 4 weeks. The patient recovered from events blacked out, severe stomach cramps, diarrhea, and vomiting on 18Mar2021; recovering from nausea; while unknown outcome for the remaining events. No follow-up attempts are possible. No further information is expected.
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| 64 | 2021-04-01 | nausea | Nausea and headache |
| 64 | 2021-04-01 | vomiting, nausea, diarrhea |
continued throwing up; diarrhea; Nausea; Slight fever; Difficult breathing/ shortness of breath; sli...
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continued throwing up; diarrhea; Nausea; Slight fever; Difficult breathing/ shortness of breath; slight pain at injection site; tired; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 64-years-old, administered in Arm Left on 26Feb2021 09:30 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included allergies: sulfites. The patient was not pregnant. There were no concomitant medications. The patient experienced slight pain at injection site and tired on 27Feb2021 12:00, nausea, slight fever, and difficult breathing on 28Feb2021, continued throwing up, diarrhea, shortness of breath on 01Mar2021. The patient experienced slight pain at injection site, tired on Saturday, then on Sunday nausea, slight fever, difficult breathing, and on Monday continued throwing up, diarrhea, and shortness of breath. The patient was hospitalized for 1 day for the events. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 08Mar2021.Therapeutic measures were taken as a result of the events which included steroid and meds for stomach. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The outcome of the events was recovered on an unspecified date. Facility type vaccine was Hospital. No other vaccine in four weeks. No other medications in two weeks. Patient was not diagnosed with COVID prior vaccination. The patient was tested for COVID post vaccination. Information on the lot/batch number has been requested.
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| 64 | 2021-04-07 | nausea |
Severe Nausea; Fatigue; Muscle and body aches; Muscle and body aches; headache; low grade fever; mal...
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Severe Nausea; Fatigue; Muscle and body aches; Muscle and body aches; headache; low grade fever; malaise; severe Tremor; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient (not pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Mar2021 at 15:15 on the left arm as single dose for COVID-19 immunization. Medical history included bipolar disorder type 2, known allergies to sulfa. Concomitant medications included taking unspecified other medications in two weeks. The patient did not receive other vaccine in four weeks. The patient previously took prochlorperazine maleate (COMPAZINE) and experienced allergies. The patient did not have covid prior vaccination and there was unknown if the patient had covid tested post vaccination. On 13Mar2021 at 12:00 PM, the patient experienced severe nausea, fatigue, muscle and body aches, headache, low grade fever, malaise 3 days after vaccine since then patient had developed a severe tremor; that all events resulted in disability or permanent damage. Patient received a positive result from a serum antibody test for covid 19 on 29Mar2021 (reported as two days ago, as of 31Mar2021). Patient cancelled her second vaccination appointment. Lab data included serum antibody test was positive on 29Mar2021. There was no treatment received for the adverse events. The outcome of events was not recovered. Information about Batch/Lot number has been requested.
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| 64 | 2021-04-07 | vomiting, nausea, diarrhea |
pain in the heart; semi-hallucinatory dreams; 3 day duration: extreme headache; fatigue; nausea and ...
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pain in the heart; semi-hallucinatory dreams; 3 day duration: extreme headache; fatigue; nausea and vomiting; nausea and vomiting; diarrhea; chills; cold sweats; fever spiking to 103.9 F; This is a spontaneous report from a contactable consumer (Patient) reporting for herself. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8727), via an unspecified route of administration, at the age of 64 years, administered on the left arm on 21Mar2021 09:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included atypical homozygous pseudocholinesterese deficiency from an unknown date and unknown if ongoing. Concomitant medications included liothyronine (LIOTHYRONINE) and levothyroxine (LEVOTHYROXINE); both taken for an unspecified indication, start and stop date were not reported. The patient received first dose of COVID vaccine BNT162B2 (lot number: EN6203) on 02Mar2021 09:00 AM on the left arm for COVID-19 immunization. On 21Mar2021 18:00, the patient experienced 3 day duration of extreme headache, fatigue, nausea, vomiting, diarrhea, chills, cold sweats, fever spiking to 103.9 F, pain in the heart and semi-hallucinatory dreams. The patient underwent lab tests and procedures which included body temperature: 103.9 fahrenheit on 21Mar2021. Treatment was not received for the events. The outcome of the events was recovering. Additional information has been requested.
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| 64 | 2021-04-08 | vomiting |
Pt received the shot on Thurs 4/1/21. This is a 64-year-old patient who presents with 1-1/2 days of ...
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Pt received the shot on Thurs 4/1/21. This is a 64-year-old patient who presents with 1-1/2 days of body aches, fevers, tachycardia, fatigue and does not have any exposure to COVID-19 but she just got on Thursday her first shot of her vaccination she also has vomiting and malaise. TTP rash started on 4/7/21.
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| 64 | 2021-04-09 | nausea |
feeling almost to pass out; lightheaded/dizzy; extreme confusion; cognitive issues (more than 'brain...
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feeling almost to pass out; lightheaded/dizzy; extreme confusion; cognitive issues (more than 'brain fog'); cognitive issues (more than 'brain fog'); nausea; weak to the point of needing to sit down often; break out in sweat a couple of times daily; arm hurt; I am not confident to drive and am having difficulty performing my dailing routine; This is a spontaneous report from a contactable consumer (patient). This 64-year-old female patient (Patient was not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date unknown), via an unknown route on 18Mar2021 at 13:30 PM (at the age of 64-years-old) at single dose on the left arm for COVID-19 immunization. Relevant medical history included neutropenia. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. The patient was perfectly well prior to vaccine administration. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She did not receive any other medications within 2 weeks of vaccination. On 19Mar2021 at 14:30 PM, she has been lightheaded and dizzy to the point of feeling almost to pass out. She had extreme confusion/cognitive issues (more than brain fog) and nausea. She was weak to the point of needing to sit down often and break out in sweat a couple of times daily. Her arm hurt for a couple of days but that has resolved. She was not confident to drive and having difficulty performing her dailing routine. The patient was concerned about ever recovering and receiving the second dose. No treatments were given for the events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The outcome of the event arm hurt was recovered in Mar2021 while the outcome of the remaining events was not recovered. Information on the lot/batch number has been requested.
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| 64 | 2021-04-11 | nausea |
Received second shot in left deltoid 4/3, mylagia 4/4, nausea 4/5, chest pressure and shortness of b...
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Received second shot in left deltoid 4/3, mylagia 4/4, nausea 4/5, chest pressure and shortness of breath started 4/6
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| 64 | 2021-04-17 | nausea |
Lymph nodes hurting a lot; Hypersensitive to light; A lot of dizziness; Nausea; Headaches; affecting...
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Lymph nodes hurting a lot; Hypersensitive to light; A lot of dizziness; Nausea; Headaches; affecting all organs; Chest pain; Felt like the Covid-19 vaccine was hydrating eyes/Film on eyes; Losing vision; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6208), first dose via an unspecified route of administration on 16Mar2021 10:30 (at the age of 64 years old), single dose for covid-19 immunisation. Medical history included ongoing thyroid (disorder) (Unspecified thyroid condition). It is the vaccines with aluminum and bovine extract that she knows that she can't handle. Caller reported that she got a flu vaccine at work and that she definitely got the flu within a few minutes of receiving the flu vaccine. Caller reported that another time after receiving the flu vaccine, she definitely got the flu but she was unsure of the time frame. Caller reported that she did have the flu vaccine several times but that two times, the flu vaccine definitely gave her the flu. She has 3 brothers and that one of her brothers that she is a caregiver for has Type 1 Diabetes. Her brother just felt like he had to have 2 vaccines several years ago and that he received the pneumonia and flu vaccines. Her brother was hospitalized within days of receiving the flu and pneumonia vaccines. Her brother was placed in the ICU for heart patients and the medical staff at the hospital was not sure if her brother was going to live. She couldn't remember how long her brother was hospitalized for, caller stated she thinks maybe around 10 days.She knows what she knows, her 2 other brothers were also hospitalized as children. She didn't know if her brothers had vaccines before they were hospitalized but that she would bet money that vaccines they had received are what resulted in hospitalization.When hospitalized, her second brother was not expected to live. At the time of the event, her brother was only 1 or 2 years old. Her brother's infection was so bad that the hospital sent blood to the CDC and that the CDC couldn't figure out what was wrong with her brother.The hospital kept giving IV antibiotics to her brother and he lived. Her third brother hospitalized around 5 years old with pneumonia during the summer. She didn't know if her brother had received any vaccinations at that time. She just thinks the vaccines did that to them but she doesn't know that. Someone gave her first brother the information on the pneumonia and flu vaccines he received prior to his hospitalization. She didn't have information regarding the details of the vaccines that her brother received.The facility where her first brother was vaccinated with flu and pneumonia vaccines would not give her the information on the vaccines that her brother received. Caller reported that it was a really hard time to fight the facility for that information and she was shocked the facility wouldn't give her the requested information. Caller reported that they wouldn't give her any medication records or anything. Caller reported that it was a bad time for her to fight it, and that she will eventually go back and tell them they have to give her the information.Her brother that she is a caregiver for and that was hospitalized after receiving the flu and pneumonia vaccines also had the Covid-19 vaccine on 16Mar2021. Caller reported that she had been more concerned about her brother having a reaction as he has serious health issues, including Type 1 Diabetes and a heart condition. Caller reported that her brother stated that he's fine and to the caller, her brother seems fine. Concomitant medication included levothyroxine. Patient has experienced that the Pfizer Covid-19 vaccine made her hypersensitive to light on 20Mar2021. She is losing vision on Mar2021 because of the hypersensitivity to light. On 20Mar2021, patient had a lot of dizziness and nausea. It is effecting all of her organs. She has had headaches, chest pain. The Covid-19 vaccine is affecting all of her organs. Yesterday, 30Mar2021, her lymph nodes were hurting a lot, at least she thinks it was her lymph nodes. All of her organs that have been affected by the Covid-19 vaccine and that it seems like it moves day to day. She is mostly sensitive to UV light but is also sensitive to artificial light. She thinks that the hypersensitivity to light has improved a little bit but it's still a problem. The hypersensitivity to light was the absolute worst on 20Mar2021. She doesn't know how much she is still dizzy when asked if it was still ongoing. She added she has been taking Benadryl and ginger for the dizziness and nausea and it helps a lot.She has been taking ginger for the nausea, and if she still has a little, it's not as much.Today is an overcast day and that it's an easy day for her. Caller reported that bright, sunny days are the worst.She was unsure of when the vision loss occurred but stated that she knew by 20Mar2021 that she had lost vision. She didn't know if she was continuing to lose vision but she can tell she lost vision. She did have a headache in the evening on 16Mar2021 after receiving the Covid-19 vaccine. She thinks the headache occurred in the evening on 16Mar2021.She may have had some headaches between 16Mar2021 and 20Mar2021, but that the headache she had on 20Mar2021 was a horrible headache.She is still getting headaches. She would say the headaches are a little better but she is still having them.She is having headaches that she doesn't think she would normally have. She wasn't having headaches before receiving the Covid-19 vaccine.She thinks she did have headaches between 16Mar2021 and 20Mar2021, but 20Mar2021 is when the headaches really hit her.The chest pain is intermittent and that the chest pain coincides with when the light is affecting her. When it's UV light, more so in the afternoon on sunny days, but technically the artificial light in the evening some days bothers her too.She doesn't think her lymph nodes were bothering her before 29Mar2021. Her lymph nodes are ok this morning, 31Mar2021.Different organs have hurt at different times. The effect on organs started within minutes of getting the Covid-19 vaccine.She could feel her eyes and that her eyes felt different within minutes of getting the Covid-19 vaccine. It felt like the Covid-19 vaccine was hydrating her eyes on 16Mar2021 but at the time it felt good. Afterward she was freaking out because she was concerned about her eyes.In the evening of 16Mar2021, it seemed like there was a film on her eyes and she had a headache.On 17Mar2021, 18Mar2021, and 19Mar 2021 she had headaches that she wouldn't have normally had.On 20Mar2021 different organs started hurting.Her biggest concern was the chest pain. After looking back on it, the chest pain may have started between 17Mar2021 and 19Mar2021 also.The effect on her organs from the Covid-19 vaccine occurs on different organs at different times on different days. The effect today isn't bad because it overcast outside and that her organs are really affected when she is exposed to a lot of light.She had 2 blood tests yesterday at her primary care doctor. The doctor ordered labs for VEGF and Leptin. She doesn't get vaccines.No Prior Vaccinations (within 4 weeks). The outcome of the event Photophobia, Nausea, Headache, Lymph node disorder was recovering; other events was unknown. Follow-up attempts are completed. No further information is expected.
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| 64 | 2021-04-20 | appendicitis, abdominal pain, abdominal discomfort |
Appendicitis; Abdominal pain/abdominal soreness; stomach started bothering her; not feeling well; ti...
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Appendicitis; Abdominal pain/abdominal soreness; stomach started bothering her; not feeling well; tired; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration, administered on the left arm on 25Mar2021 10:00 at a single dose for COVID-19 immunisation. Medical history included ongoing asthma (Never smoked a cigarette in my life), Hypothyroidism (started taking levothyroxine about 23 years ago), Diverticulitis (hospitalized for it once in 2015), allergy and environmental allergies. Concomitant medications included levothyroxine for hypothyroidism, loratadine for asthma is triggered by allergies, montelukast for allergy from 2017, fluticasone propionate, salmeterol xinafoate (SALMETEROL AND FLUTICASONE) taken for asthma from 2017, albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) taken for asthma attack and fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) taken for environmental allergies from 2017 all were ongoing. The patient previously received first dose of BNT162B2 on 03Mar2021 for COVID-19 immunization (IM left arm); flu vaccine (Received every year for the past 14 years) and pneumonia vaccine (gotten the pneumonia vaccine the year prior) both for Immunisation. On 26Mar2021, caller stated that she was not feeling well, her stomach started bothering her and she thought she was going to have diarrhea, but she did not. She was really tired, stating she had to take her mom to an appointment, which was about an hour away and patient slept in the car on the way, and noted that she never sleeps in the car. Felt really really tired. On 28Mar2021 her stomach pain started. She thought it was diverticulitis and that she has history of having diverticulitis years ago and being hospitalized for it once in 2015. She got very sick very quickly. She went to the emergency room on 28Mar2021 at about 1130 and they did a CT scan and found out it was her appendix and she was operated on that afternoon at which time they removed her appendix. Appendicitis require a visit to the emergency room. The patient was hospitalized for appendicitis from 28Mar2021 to 29Mar2021. The doctor told her that she was very fortunate, there was a slight perforation and there was no leakage and she was able to go home on early Monday evening. Shortly after the surgery she felt better. She still does not feel 100% still tired. Glad she got the surgery when she did and it did not rupture. Stated she did not need pain medication. There were no additional vaccines administered on same date of Pfizer suspect. Outcome of the events appendicitis and stomach started bothering her was recovered on 29Mar2021, not feeling well recovered on 28Mar2021, event tired as not recovered while unknown for the other event. Information on the lot/batch number has been requested.
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| 64 | 2021-04-21 | diarrhea |
Five days after receiving the Pfizer vaccine, I had a sudden onset of neck & shoulder pain on my lef...
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Five days after receiving the Pfizer vaccine, I had a sudden onset of neck & shoulder pain on my left side, radiating up into my left ear & across my chest. My chest was tight. It hurt in my neck and shoulder and chest to take a deep breath. Shortly after, I felt jittery inside & started getting chills. The backs of my legs were quaking against the chair and I got really cold. My blood pressure went up to 149/78. I also had one bout of diarrhea.
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| 64 | 2021-04-24 | abdominal pain upper, vomiting, nausea |
stomach ache; Day two past out; bodyaches; vomited; Headache; nauseous; fever; This is a spontaneous...
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stomach ache; Day two past out; bodyaches; vomited; Headache; nauseous; fever; This is a spontaneous report from a contactable consumer (patient). A 64-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: Ew0151), via an unspecified route of administration, administered in left arm on 05Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 15Mar2021 for COVID-19 immunization. The patient had no other vaccine in four weeks. It was reported that on day two (06Apr2021), the patient past out and vomited. The patient also experienced headache, nauseous, fever, bodyaches on 06Apr2021; and stomach ache on 10Apr2021. No treatment was received for the events. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. The outcome of the events was not recovered.
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| 64 | 2021-04-24 | indigestion |
Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms las...
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Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing; Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing; Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing; Headache; distorted facial sensory; slight torso rash; tremor; spasticity; cognitive fog; fatigue; joint/tendon stiffness/inflammation; joint/tendon stiffness/inflammation; slightly increased temp; sensory distortion; cutaneous vasculitis on feet (aka "COVID toes"); slow digestion; This is a spontaneous report from a contactable consumer. A non-pregnant 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on right arm on 10Mar2021 13:00 (Batch/Lot Number: EN6200) at single dose (at the age of 64 years old) for COVID-19 immunisation. Medical history included known allergies: oats, also saturated fats (trigger multiple sclerosis symptoms), intolerant of many drugs but not allergic, Multiple sclerosis/fibromyalgia, systemic rheumatoid disease, Raynaud's, underweight and very low bone density . Concomitant medications included naltrexone taken for an unspecified indication, start and stop date were not reported. On 11Mar2021, the patient experienced headache and distorted facial sensory, slight torso rash, flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing. Includes tremor, spasticity, cognitive fog, fatigue, joint/tendon stiffness/inflammation, sensory distortion, cutaneous vasculitis on feet (aka "COVID toes"), slow digestion, slightly increased temp. No new symptoms yet. Postponed 2nd dose due to flare. The patient received no treatment. The outcome of the events was recovering.
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| 64 | 2021-04-24 | nausea |
passed out two times; Left arm shoulder and neck completely numb; Left lower section of my head seve...
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passed out two times; Left arm shoulder and neck completely numb; Left lower section of my head severe pain; dizziness; vertigo; nauseous; heavy sweats; my head feels very foggy; Having spots of memory issues; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 30Mar2021 11:30 (Batch/Lot Number: EM9810) as single dose for covid-19 immunization. Medical history included asthma, neuropathy, high cholesterol, and several allergies from an unknown date. The patient has no history of COVID prior vaccination. She was not COVID tested post vaccination. Concomitant medications included duloxetine hydrochloride (CYMBALTA) taken for an unspecified indication. The patient previously received the first dose of BNT162B2 (Lot number=EN6200) on 09Mar2021 12:15, on left arm for COVID-19 immunization. The patient experienced having left arm, shoulder and neck completely numb for four days since 30Mar2021, 19:00. Left lower section of her head with severe pain; she had dizziness, vertigo and was nauseous. She started having heavy sweats and passed out two times. She reported it has been a week since she had the shot and she was still dizzy and her head feels very foggy. She was also having spots of memory issues. The events were experienced on 30Mar2021, 19:00. No treatment was received for the events. The outcome of the events was not recovered from dizziness, and recovered with sequela from "Left arm shoulder and neck completely numb" on 03Ape2021, and recovered with sequelae on an unspecified date for other events..
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| 64 | 2021-04-25 | vomiting, abdominal pain |
my auntie, who was trying to be supportive and to get vaccinated just passed away like this is not w...
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my auntie, who was trying to be supportive and to get vaccinated just passed away like this is not worse it. My auntie, passed away the next two days after she got her Pfizer Covid vaccine. My auntie, who is 65 years old, got her Pfizer vaccine the the morning of April 22 2021. She told us he was completely find on the day of the vaccine. But the next morning around 9 am, she told us she has severe abdominal pain, has the need to have a bowel movement, but she was defecated. She also told us that she vomit couple times already, then she has no more energy to talk. She got into the hospital and she was announced right after midnight at 12:04 April 25th. The reported death reason is due to Bowel Ischemia with Perforation and it has nothing to do with Pfizer vaccine that she got. But I believe it is her post Pfizer covid vaccine reaction that result in Bowel Ischemia with Perforation. My auntie lived with a very healthy life style. She walked every morning, and has a shorter walk in the evening. She has no blood pressure, no blood sugar, everything is fine with her medical check. My auntie had a kidney transplant 20+ years ago and she is on the track for monthly doctor visit. When she asked her general doctor if she could get the vaccine, her general doctor asked her to consult her kidney doctor. She then went to ask her kidney doctor and her kidney doctor call her general doctor to discuss her health conditions. Both of her doctor decided that she could take the vaccine and one of the doctor registered her for the vaccine on April 15 2021. The she nurse told her to came in for vaccine on Apr 22, and she is now death after the Pfizer vaccine. I only read about people with recent organ transplant is not recommended to take the Covid vaccine. But there is no information about people that ever had kidney transplant shouldn?t take the vaccine. My auntie, who was trying to be supportive and to get vaccinated just passed away like this is not worse it without a clear explanation. I would like you to contact health department to follow up on this case and find out the real root cause. If the vaccine is not recommended for people that ever got kidney transplant, CDC should publish the information so that there won?t be more victims. Please take necessary action ASAP. Thank you!
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| 64 | 2021-04-27 | diarrhea, abdominal pain upper, vomiting |
? Tuesday, April 6th ? Patient receives the 2nd Pfizer vaccine shot ? Thursday, April 8th ? Patient ...
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? Tuesday, April 6th ? Patient receives the 2nd Pfizer vaccine shot ? Thursday, April 8th ? Patient is sick with vomiting and diarrhea ? Friday, April 9th ? Patient is delirious and still sick with vomiting and diarrhea. She is also has pain in her stomach. An ambulance is called to take her to the hospital. The hospital determines her white blood count is elevated, indicating an infection. Blood sugar is very high ? approximately 400. Covid test is negative. She is restless upon arrival. She tries to climb out of bed continuously. She is restrained. o Saturday, April 10th ? Patient is running a fever and is in pain. She is also confused and doesn?t recognize her oldest sister. Meds are administered to handle both items. (Toradol?). Blood sugar around 200. She continuously counts and calls for Mother and Father. Patient continues to be restless o Sunday, April 11th - at request of family, a CT scan is done of her stomach and abdomen. Nothing is found. Potassium was at 3.2 (normal is 3.5) so she received an IV drip to help with potassium levels. Sugar ? 206. Later drops to 176. Patient calms down some. She is still confused and doesn?t recognize her oldest sister. ? Monday April 12th ? the hospital attempts to do an MRI, but patient panics. This is a closed MRI and her 1st husband died in one. The MRI isn?t done. ? Tuesday, April 13th ? she is asked by the doctor to state her name and wiggle her toes. She complies. Doctor orders speech therapy. She is sedated for an MRI and a CT scan. Both are successfully completed. She sleeps for the rest of the day. Blood sugar ? 274 @ 5:09pm. ? Wednesday, April 14th ? Patient was asleep all day. Most of the day she isn?t responsive when nurses come in and do things like take blood. She normally responds even if she is asleep. Around 5pm she starts to respond and make noises; she briefly opens her eyes then falls asleep. She continues to run a temperature. ? Thursday, April 15th ? Patient is asleep most of the day. She is responsive when nurses do things like take blood. A spinal tap is performed. There was mention of dementia. Hospital is sharing little information, varying from she is retreating into herself vs. something worth isolating is going on. Temp was 102.3 at 7:37, but later dropped to 99.3 without meds. Dr. (neurologist) provides an update to the family. Tests so far are negative. EEG showed sleeping brain (she was asleep during test). MRI showed nothing. Spinal tap negative so far. No infection or anything has shown up. Orders another EEG and MRI ? Friday, April 16th ? Patient tried to open her eyes. ? Saturday, April 17th ? a met code was called on her and she was moved to ICU. A circulation issue was found in right leg. Occlusion was really bad. Initially the doctor was concerned about blood clots. None were found, just swelling. Pressure was relieved. Blood pressure issues. She was put on 2 blood pressure meds, at least. She was dehydrated and acidic. Diabetic ketoacidosis was mentioned. A cytokine storm was expected. ? Sunday, April 18th ? blood pressure not stable. She was put on dialysis. Peripheral circulation was worse. ? Monday, April 19th ? she coded around 5am. Doctors were trying to save her. She passed away about 30 minutes later .
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| 64 | 2021-04-30 | decreased appetite, diarrhea, nausea, vomiting |
Patient presented to ED on 3/28/21 with the following information: patient reports home daughter wa...
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Patient presented to ED on 3/28/21 with the following information: patient reports home daughter was diagnosed with COVID-19 infection a few days ago. For about a week now the patient herself has had severe fatigue, loss of taste, loss of appetite, nausea, vomiting and diarrhea. She denies fevers. She has however had a persistent cough and over the last few days has been short of breath. Tested positive for COVID-19 on 3/27/2021 at outside facility. Last night patient had multiple episodes of diarrhea making her fatigue significantly worse today. Has been drinking a lot of free water. Additionally noted increased cough and shortness of breath. Patient was admitted to the hospital with COVID-19 pneumonia on 3/28/21 and expired on 4/13/21.
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| 64 | 2021-05-02 | diarrhea | diarrhea, severe muscle aches, headache, extreme fatigue |
| 64 | 2021-05-03 | diarrhea, nausea, vomiting |
Angioedema; Shock; stridor; dry cough; Hoarse voice; Sneezing; Rhinorrhea; Dizzy; nausea; Hypotensio...
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Angioedema; Shock; stridor; dry cough; Hoarse voice; Sneezing; Rhinorrhea; Dizzy; nausea; Hypotension; Weakness feeling; Generalized erythema; Generalized pruritus with skin rash; Generalized pruritus with skin rash; Diarrhoea; Vomiting; Throat closed in; the sides of the throat, down my neck , straight over my chest felt as if someone was squeezing me, chest felt heavy; Potential anaphylactic reaction; Difficulty breathing; severe brain fog; Severe chest pain hard to breath felt as if being smothered; difficult to sleep nights before as felt wired after the shot; bp slightly elevated 140/80; Became very groggy; eyes heavy, had about 3 sleep attacks; 3 sleep attacks; This is a spontaneous report from a contactable Health Care Professional (patient). A 64-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EN4206) at single dose, intramuscularly, in the left arm, on 05Mar2021 at 10:00 AM, for COVID-19 immunization. The patient also received hylan g-f 20 (SYNVISC), via an unspecified route of administration, in knee, on 04Mar2021, at single dose, for an unspecified indication. Relevant medical history included narcolepsy from an unspecified date, in 1973, cataplexy from an unspecified date, complex regional pain syndrome (CRPS) from an unspecified date, in 2003, osteoporosis from an unspecified date, gastrooesophageal reflux disease (GERD) from an unspecified date, hypertension from an unspecified date and arthritis from an unspecified date, in 2003. Concomitant medications included methylphenidate hydrochloride (RITALIN), imipramine, baclofen, atenolol, rosuvastatin calcium (CRESTOR), ezetimibe (ZETIA), imipramine hydrochloride (TOFRANIL), montelukast sodium (SINGULAIR), acetylsalicylic acid (BABY ASPIRIN) and clonidine, all taken for an unspecified indication, start and stop date were not reported. The patient reported allergy for drugs like lisinopril, spirolactone, ghb (gamma-Hydroxybutyric acid), epinephrine and all seizure type medications. The patient became very groggy, felt eyes heavy, had about 3 sleep attacks, on 06Mar2021, at 13:00. Also reported difficulty to sleep nights before as felt wired after the shot (insomnia) and bp was slightly elevated 140/80 on 07Mar2021. On 27Mar2021 at 13:00, throat closed in, felt the sides of the throat, down her neck, straight over her chest felt as if someone was squeezing her, chest felt heavy (severe chest pain hard to breath, felt as if being smothered, throat closing in severe chest heaviness). Severe brain fog. Potential anaphylactic reaction and difficulty breathing were reported. On an unspecified date, the patient experienced angioedema, shock, stridor, dry cough, hoarse voice, sneezing, rhinorrhea, dizzy, nausea, hypotension, weakness, generalized erythema, generalized pruritus with skin rash, diarrhoea and vomiting. Decrease level of consciousness and loss of consciousness were not reported. The patient underwent lab tests and procedures which included oxygen saturation: normal on 06Mar2021 and blood pressure measurement: 140/80, slightly elevated, heart rate: 99, respiratory rate: 20 on 07Mar2021. The patient was not hospitalized and was not admitted to an Intensive care unit. The patient did not have COVID prior to vaccination and the patient did not test COVID post vaccination. The patient recovered from throat constriction, chest heaviness, potential anaphylactic reaction and difficulty breathing. Clinical outcome of angioedema, shock, chest pain, stridor, dry cough, hoarse voice, sneezing, rhinorrhea, dizzy, nausea, hypotension, weakness, generalized erythema, generalized pruritus, skin rash, diarrhoea and vomiting was unknown. Outcome of the other events was reported as recovering. Follow up attempts are completed. No further information is expected. Follow up (26Mar2021): New information received from a contactable Health Care Professional includes: adverse events added, clinical course and case seriousness updated from non-serious to serious. Follow-up (20Apr2021): New information received from a contactable Health Care Professional includes: medical history, concomitant medications details and additional adverse events added (Potential anaphylactic reaction and difficulty breathing added as additional adverse events). Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on known safety profile and/or temporal association, the contribution of the suspect drug to the onset of serious events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 64 | 2021-05-07 | vomiting, abdominal pain upper, diarrhea, nausea |
feeling so bad; couldn't hold anything down/Vomiting that wouldn't stop/vomiting; Diarrhea; Nauseous...
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feeling so bad; couldn't hold anything down/Vomiting that wouldn't stop/vomiting; Diarrhea; Nauseous; It was just bile coming up; Headache; Was passing clots/were clots/in the vaginal area; Was passing clots/were clots/in the vaginal area/vaginal bleeding; Being dehydrated; couldn't hold her own weight up; stomach pain; So sick; White blood cell count and kidney and liver function were all elevated; White blood cell count and kidney and liver function were all elevated; White blood cell count and kidney and liver function were all elevated; A sharp pain in her side; Stools were dark tarry stringy stuff; Stools were dark tarry stringy stuff; Passing blood in her urine; allergic internal reaction; Weighing 130 pounds but lost about 4 pounds during this illness, so 4 pounds lighter; This is a spontaneous report from a contactable consumer (patient herself). A 64-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, at age 64 years, administered in left arm on 05Apr2021 10:30 (Batch/Lot Number: ER8734) as single dose, for COVID-19 immunization, in order to go back to normal, without a mask so she was told she had to have one. Medical history included hysterectomy, anxiety, disorder in thyroid and cholesterol. Patient had family history of dementia, had to stay home and take care of her mom who is a heart patient and has dementia. Patient had no history of previous immunizations. Patient's concomitant medication includes unspecified medications one is for thyroid, one is for cholesterol and the other 2 are for anxiety. Patient had no prior vaccinations within 4 weeks. No additional vaccines administered on the same date. Patient's symptoms started with a headache the morning after the shot (05Apr2021), was on and off for a couple of days, lasted 3 days or so for a couple days and she took paracetamol (TYLENOL). On 09Apr2021, Friday morning, patient woke up so nauseous she couldn't hold anything down. It was just bile coming up, and she had severe diarrhea and so sick vomiting that wouldn't stop, stomach pain, couldn't hold her own weight up. She got medication at a walk in clinic and that didn't stop it. She started out at acute/urgent care, where she was taken by her daughter on Sunday, 11Apr2021, because she was feeling so bad and was tested for COVID and they said if it does not get better to go to the Emergency Room and she continued having problems. It was not COVID. They said she was dehydrated and send her home to push fluids and drink Pedialyte. Monday or Tuesday (Apr2021) she was in the ER all night (she does not remember the day because all of her days are mixed up). They did CAT scans on her abdomen and ran blood work. They didn't see anything in her abdomen. Her white blood cell count and kidney and liver function were all elevated and they said it was from being dehydrated from diarrhea and vomiting. They gave her fluids and sent her home. Within another 48 hours she still had vomiting and diarrhea, it was a clear bile and a sharp pain in her side. Her stools were dark tarry stringy stuff so she went back to the ER and waited in the lobby for 9 hours. In that 9 hours as she was waiting, she felt like she had to go to the bathroom. She was then wheeled into the bathroom and started passing blood. It wasn't coming from the urethra. It must have come form the vagina, she doesn't have a uterus. There were clots. She started passing blood in her urine but most was in the vaginal area but she has already had a hysterectomy. She was passing clots and her doctor who works in the healthcare field looked at it and said they were clots. Very shortly after, she passed the clot and the pain went away. The pain was passing clots/were clots/in the vaginal area at one point went away but she still have nausea and diarrhea and they gave her more fluids and sent her home. They didn't really want to address the vaginal bleeding. Patient have not been back and was not sure if she is still dehydrated. Patient was still pushing fluids and still not back to normal. Patient's daughter told her that since it was 5 days later it was not a reaction. Patient was thinking maybe it was an allergic internal severe reaction. Patient was weighing 130 pounds but lost about 4 pounds during this illness, so 4 pounds lighter. She stated her daughter-in-law was doing research and found a blog and there are woman the caller's age complaining of these symptoms (unexplained bleeding) after the vaccine. She asked if this was from the vaccine. She stated she was so sick that if there is even a chance then she doesn't want the second dose. She asked if this is a coincidence or has it been reported. She stated she is trying to make a decision on if she should get the second dose because she heard other people have symptoms and take the second shot. The outcome of the events passing clots/were clots/in the vaginal area, headache, a sharp pain in her side, passing blood in her urine, passing clots/were clots/in the vaginal area/vaginal bleeding was recovered on Apr2021, while for the other events, it was unknown.
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| 64 | 2021-05-10 | abdominal pain, nausea | Abdominal pain, chest pain, nausea, and dizziness |
| 65 | 2021-01-01 | diarrhea | Diarrhea for 3 hours |
| 65 | 2021-01-03 | diarrhea |
Jan 3, 2021 mild pain at injection site, diarrhea all day, chills in morning , no fever, temp 97.6 J...
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Jan 3, 2021 mild pain at injection site, diarrhea all day, chills in morning , no fever, temp 97.6 Jan 4, 2021 significant arm pain at injection site (awakened by it at 3 am) with chills, temp 99.6. Took One tablet ALEVE followed by temp 98.6
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| 65 | 2021-01-04 | decreased appetite |
Pain, Edema and erythema in 4 cm circumference around injection site; Pain, Edema and erythema in 4 ...
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Pain, Edema and erythema in 4 cm circumference around injection site; Pain, Edema and erythema in 4 cm circumference around injection site; Pain, Edema and erythema in 4 cm circumference around injection site; Myalgia; headache; anorexia; fatigue; weight loss; sweats; This is a spontaneous report from a contactable physician (patient). A 65 years old years female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EM9899) via an unspecified route of administration at Left arm on 22Dec2020 01:15PM at single dose for COVID-19 immunization. The patient's medical history included hypertension, body mass index (BMI) 30, hypothyroidism and Covid-19. Known allergies: penicillin, sulpha drugs, seasonal allergies. No other vaccine in four weeks. The concomitant was reported as hydrochlorothiazide, losartan potassium (HYZAAR), levothyroxine sodium (SYNTHROID), Metformin. The patient experienced pain, edema and erythema in 4 cm circumference around injection site myalgia, headache, anorexia, fatigue, weight loss, sweats, all started from 24Dec2020. No treatment received for events. The outcome of the events was recovering.
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| 65 | 2021-01-04 | diarrhea |
She thought maybe she had food poisoning bc of the weird symptoms; headache; achy muscles; loose sto...
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She thought maybe she had food poisoning bc of the weird symptoms; headache; achy muscles; loose stools; sore arm; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EH9899), on 20Dec2020 at single dose for covid-19 immunisation. Medical history included None. There were no concomitant medications. The patient experienced loose stools on 25Dec2020, headache on 26Dec2020, achy muscles on 26Dec2020, sore arm on 20Dec2020, she thought maybe she had food poisoning bc of the weird symptoms on an unspecified date. She initially had a sore arm and the usual effects which she expected. Then, about six days into it she started having a headache and achy muscles. It all started with loose stool. She did get a COVID test because of signs of COVID. But it was negative. She thought maybe she had food poisoning bc of the weird symptoms. The headaches were bad, but they were not as bad currently. She had a loose stool that lasted a couple of days. The headaches were really mild currently. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 28Dec2020. Outcome of loose stools, sore arm was recovered in Dec2020, headache was recovering, achy muscles was not recovered, other was unknown.
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| 65 | 2021-01-04 | nausea |
I had a temperature of 103.8; nauseated and dizzy; eyes hurting; headache; chills; tired; nauseated ...
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I had a temperature of 103.8; nauseated and dizzy; eyes hurting; headache; chills; tired; nauseated and dizzy; pain at the site; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 23Dec2020 at 10:30 as single dose for covid-19 immunization. Medical history included covid-19 from May2020. The patient's concomitant medications were not reported. The patient reported that " I had a temperature of 103.8 " on an unspecified date with outcome of unknown; pain at the site on 23Dec2020 with outcome of unknown; tired on 24Dec2020 with outcome of unknown; nauseated and dizzy on 24Dec2020 with outcome of unknown; chills on 24Dec2020 with outcome of unknown; eyes hurting on an unspecified date with outcome of unknown; headache on 24Dec2020 with outcome of unknown. The patient underwent lab tests and procedures which included body temperature: 101.8 Fahrenheit; temperature: 102.4 Fahrenheit; temperature: 101.3 Fahrenheit; temperature: 100.6 Fahrenheit; temperature: 99.2 Fahrenheit; temperature: 103.8 Fahrenheit on 24Dec2020; sars-cov-2 test: positive in May2020, sars-cov-2 test: negative in 23Dec2020. Therapeutic measures were taken as a result of " I had a temperature of 103.8 ". Details were as follows: the nurse received the vaccine on a Wednesday 23Dec2020 at 10:30am. That night at her night shift, she had pain at the site. After midnight, the patient felt tiredness and felt like she had to lay down. At 6:00 she felt nauseated and dizzy. She had a temperature of 103.8. Thursday night, she went home at 7:10 and called her private doctor. The temperature was 101.8 and then it went down. The nurse had been administered the first of 2 dose series of Pfizer BioNTech COVID-19 Vaccine on 23Dec2020. She had received mandatory COVID-19 testing on 23Dec2020, prior to being administered the vaccine; she received the negative results of that COVID-19 testing on 25Dec2020. After being administered the vaccine she was monitored for 15 minutes and then went home. She was fine, had no allergy or anything. She reported that after she was administered the vaccine, she had pain, was really tired, nauseous, chills, high temperature, and her eyes hurting. She mentioned history of COVID-19 in May2020. She works as nightshift nurse at a rehab facility. She woke up that night of 23Dec2020 around 9:00pm-10:30pm and had onset of pain in right arm at injection site which she did not take too seriously because when you get a shot you get pain. Around midnight that night 24Dec2020, she went to work and had onset of being really tired like she just wanted to sit or lay down; she felt like she had to sit down and could not stand well. She continued working that shift on 24Dec2020 but kept getting so tired and had onset of chills and was supporting herself with her med cart. She drank a little sip of ginger tea she brought to work think maybe that would help her feel better. She felt that if she drank more ginger tea she would throw up because she felt nauseous. She was really busy at work 24Dec2020 so she did not check her temperature until after 6:00am which was 103.8 degrees Fahrenheit; and thought no wonder she feels like throwing up. She finished her shift at like 7:00am. For 2 days her temperature was turning high temperature so every 6 hours she was taking Motrin 2-200mg and that would make her temperature go down. Then temperature would go back up to like 102.4 degrees Fahrenheit, she would take ibuprofen (MOTRIN) again, temperature would come down to like 101.3 degrees Fahrenheit. She continued feeling nauseated, having chills, headache and feeling nauseous which she felt all of which could be related to the temperature. She reported to her employee health at work. She thinks it's better. Saturday morning of 26Dec2020, she woke up with temperature of 100.6 degrees Fahrenheit at 7:00am which was the first time her temperature had gown down like that so she did not take the ibuprofen. She checked it again later at like 1:00 pm and temperature was 101.8 degrees Fahrenheit so she took 2 Motrin again. After that her temperature did not go up like that anymore, it was like 99.2 degrees Fahrenheit. As soon as she came from work on 24Dec2020 she called her doctor's office and was seen by Nurse Practitioner who let her out of work for like 2 days. She reported her eyes also have been hurting, mostly her right eye is still hurting, the top is hurting like when you have a small pimple so she keeps checking but does not see anything with her eye. She couldn't even put a cold compress on for the temperature because of her headache and her eyes hurting. She could not even put cold compress to bring her temperature down. Seriousness criteria of all events was unknown. The patient has had no rash, no breathing problems, no coughing, no sore throat or other serious events. She was scared because she wondered if she had COVID-19 again with these events. She mentioned if people do not know these are side effects they would be scared, but she knows from the information she got with the Pfizer BioNTech COVID-19 Vaccine that these are normal for everyone. The only thing she wondered about is if the tiredness she is having is serious or not. She reported prior to getting the COVID-19 vaccine she tested positive for COVID-19 in May2020 and was very sick at that time because she works in a health field with COVID-19 patients. Pfizer BioNTech COVID-19 Vaccine. The patient indicated that she was fine before she got the vaccine; she had no cold, no coughing, no sore throat. The ibuprofen tablet was administered as 200 mg, 2 of the tablets at a time. : The outcome of all the events was unknown. The relatedness of the event, pain to the suspect drug was reported as related from the reporter using the assessment; relatedness of the event, really tired to the suspect drug was reported as related from the reporter using the assessment; relatedness of the event, nauseous to the suspect drug was reported as related from the reporter using the assessment; relatedness of the event, chills to the suspect drug was reported as related from the reporter using the assessment; relatedness of the event, high temperature to the suspect drug was reported as related from the reporter using the assessment; relatedness of the event, eyes hurting to the suspect drug was reported as related from the reporter using the assessment. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
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| 65 | 2021-01-04 | nausea |
fever; chills; headache; nausea; General malaise 22Dec./ On 24Dec malaise; This is a spontaneous rep...
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fever; chills; headache; nausea; General malaise 22Dec./ On 24Dec malaise; This is a spontaneous report from a contactable Nurse (patient). A 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in left arm on 21Dec2020 17:30 at single dose for COVID-19 immunization. Medical history included Crohns disease, Penicillin allergy. The patient previously took nystatin and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, the patient received other unspecified medications within 2 weeks of vaccination. The patient experienced general malaise 22Dec2020. On 23Dec2020, experienced fever, chills, headache, and nausea. On 24Dec2020, experienced malaise. No treatment received for the adverse events. Events outcome was recovered on Dec2020. Information about lot/batch number has been requested.
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| 65 | 2021-01-05 | nausea | Fever, chills, headache, nausea. |
| 65 | 2021-01-05 | vomiting, nausea |
Dizziness, Headache, NauseaVomiting, terrible vertigo 2 days after vaccine, also very nauseated Narr...
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Dizziness, Headache, NauseaVomiting, terrible vertigo 2 days after vaccine, also very nauseated Narrative: Did not have to seek any medical attention, symptoms began to resolve after 3 days, but was off of work for a day. Mostly recovered, just slight vertigo.
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| 65 | 2021-01-06 | nausea, vomiting, abdominal pain, abdominal distension |
NauseaVomiting Narrative: Received vaccine on 12/28/2020 . Was doing well until one hour before the...
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NauseaVomiting Narrative: Received vaccine on 12/28/2020 . Was doing well until one hour before the call. C/O of abdominal cramp, distention, nausea. No vomiting, temperature was 99.7F. No similar episodes before. No rash.
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| 65 | 2021-01-07 | abdominal pain |
Abdominal cramps; "someone's pulling my hair"; headache; muscle pain; feeling sick; feeling warm; Th...
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Abdominal cramps; "someone's pulling my hair"; headache; muscle pain; feeling sick; feeling warm; This is a spontaneous report from a contactable Nurse reporting for herself. A 65-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899), via an unspecified route of administration in the left arm on 02Jan2021 12:00 at single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medication included amlodipine (unknown manufacturer) and multivitamins. On 02Jan2021 at 03:00 AM the patient experienced abdominal cramps, "someone's pulling my hair", headache, muscle pain, feeling sick, feeling warm with outcome of recovering. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19. No follow up attempts are possible. No further information is expected.
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| 65 | 2021-01-07 | decreased appetite | Body aches, bone pain and extreme fatigue, loss of appetite |
| 65 | 2021-01-07 | nausea | awake most of the night, body aches, muscle pain, joint pain, chills, nausea, HA, ok today |
| 65 | 2021-01-09 | nausea |
Vaccinated at 8 am,at about 7 pm I had site and muscle pain 12/31/20,then 48 hours I had loss of s...
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Vaccinated at 8 am,at about 7 pm I had site and muscle pain 12/31/20,then 48 hours I had loss of smell and taste,body aches,I was itchy all over,could not sleep that nite,I called did the Conversation at work and told me not to go to work,the next day 1/3 /21,employee health called me to get tested and tested positive on 1/4/21,I was place on quarantine for 10 days,I tried calling your office with 800 number and left my number nobody called me,I also experienced eye irritation,cough ,short of breath,low grade fever,nausea fatigue
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| 65 | 2021-01-09 | nausea | 2 days after injection, nausea, projectile vomiting, 1 episode of unwitnessed syncope |
| 65 | 2021-01-10 | gastrointestinal disorder, vomiting, diarrhea |
I developed rigors with high fever 39.4 C. I was coughing, non-productive cough, pain at the base o...
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I developed rigors with high fever 39.4 C. I was coughing, non-productive cough, pain at the base of my lungs from coughing, running nose, muscle pain, GI problems- vomited once and stool foul smelling, loose. I developed hematuria- visit to Patient first, placed on an antibiotic. Continued with high fever and shivers- went to Emergency Department, admitted. Started on cefuroxime- fever and symptoms subsided. Discharged home. One week at home- getting stronger by day. Back to work January 11, 2021
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| 65 | 2021-01-10 | nausea | Headache, dizziness, nausea, body aches |
| 65 | 2021-01-10 | nausea |
Headache, fever (101.7), nausea, lethargy for several hours on day after vaccine was administered. F...
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Headache, fever (101.7), nausea, lethargy for several hours on day after vaccine was administered. Fever broke during the night. Energy level was still low second day after, slight headache that morning.
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| 65 | 2021-01-11 | diarrhea, nausea |
non stop diarrhea; nausea; chills; joint pain; sore at the injection site; This is a spontaneous rep...
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non stop diarrhea; nausea; chills; joint pain; sore at the injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration on 02Jan2021 07:30 at single dose for covid-19 immunization. The patient's medical history was none, and there were no concomitant medications. The first dose patient received on 02Jan2021 morning, and she just had symptoms she expected, she was sore at the injection site and she had some joint pain on 03Jan2021, but those disappeared on 04Jan2021. On 05Jan2021, she woke up and had non stop diarrhea with a little bit of nausea. Patient had not had a fever, but did feel chilled. Patient didn't think she ate anything bad. She was suspecting this may be a side effect of the vaccine. Patient didn't have a prescribing doctor. She got it at the hospital she worked at. She received it the 02Jan2021 7:30 am. Patient started the diarrhea on 05Jan2021 morning at 8:30. The nausea was on and off, but started this morning as well. Patient didn't take any ongoing medication. Outcome of events sore at the injection site and joint pain was recovered on 04Jan2021, outcome of event diarrhea was not recovered, and outcome of events nausea, and chills was recovering.
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| 65 | 2021-01-11 | diarrhea | Chills with fever, Acute diarrhea |
| 65 | 2021-01-11 | nausea |
headache; chills; nausea; This is a spontaneous report from a contactable nurse (patient). A 65-year...
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headache; chills; nausea; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 21Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache, chills, and nausea on an unspecified date. The patient asked if she is going to get the same reaction on the second dose. The outcome of events was unknown. Information on the Lot/Batch number has been requested.
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| 65 | 2021-01-12 | diarrhea | chills, low grade fever, diarrhea |
| 65 | 2021-01-14 | difficulty swallowing |
Patient presented with history of anaphylaxis to shellfish. Nurse advised patient of need for 30 min...
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Patient presented with history of anaphylaxis to shellfish. Nurse advised patient of need for 30 minute wait post covid 19 vaccine. Patient complied. After initial 30 minute wait, patient complained her mouth was dry and asked for water. Water provided, patient denied other symptoms. Based on history patient advised to wait another 20 minutes, and notify staff prior to leaving. 5-10 minutes later husband alerted nurse that she was feeling worse. Upon assessment, patient complained of swollen tongue, and difficulty swallowing. Adverse reaction protocol initiated. Client laid on cot, vitals taken, EMS called. Tourniquet applied above vaccination site, distal pulse check every 5 minutes. Nasal cannula, 4L applied. Blood pressure high, patient became flushed, complained of worsening in swallowing. Epi pen given in right thigh, Benadryl given IM in right deltoid. EMS arrived and took over care. Patient transported to hospital.
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| 65 | 2021-01-17 | vomiting | Felt fine for the first 18 hours post-dose then woke up at 3am and had a violent episode of vomiting |
| 65 | 2021-01-18 | appendicitis, nausea, vomiting |
Appendicitis; Vomiting; Nausea; Chills; This is a spontaneous report from a contactable consumer. A...
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Appendicitis; Vomiting; Nausea; Chills; This is a spontaneous report from a contactable consumer. A consumer reported that her 65-year-old mother received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number Unknown), into the arm at single dose on 31Dec2020 for COVID-19 immunization. The patient did not have any medical history and did not receive any concomitant products. On 31Dec2020 the same evening of vaccination, the patient experienced vomiting, nausea and chills that were considered flu like. On 03Jan2021 or 04Jan2021 her appendix ruptured. She entered emergency room on 07Jan2021 and was diagnosed with appendicitis. She was admitted to hospital on 07Jan2021. She has been given hospital care for past four days. She will have surgery in 6 weeks to repair and right now they are cleaning ruptured area. Her care team is wondering if she should get second dosage. The patient is currently hospitalized. The patient recovered from the event vomiting on 31Dec2020, recovered from the events Nausea and Chills on 07Jan2021 and was Recovering from the appendicitis. Information on the lot/batch number has been requested.
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| 65 | 2021-01-18 | diarrhea, abdominal pain | Runny nose, diarrhea, headache, fatigue, abd pain. |
| 65 | 2021-01-18 | nausea, diarrhea, vomiting | Fever, chills, nausea, h/a, fatigue, vomiting lasting > 48* |
| 65 | 2021-01-19 | nausea | Felt hot; chest tightness; nausea; metallic taste in her mouth |
| 65 | 2021-01-19 | nausea | fever, myalgia, rash, headache, nausea, fatigue |
| 65 | 2021-01-19 | retching, abdominal discomfort, decreased appetite |
Very upset stomach, could not eat anything in the AM and broth at lunch time. Dry heaving. Ate ver...
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Very upset stomach, could not eat anything in the AM and broth at lunch time. Dry heaving. Ate very little all day and went to bed at 6:30pm Lasted about 24 hours
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| 65 | 2021-01-19 | vomiting, nausea |
passed out; dizzy; hit the ground; nausea; pain at injection site; fever; chills; tired; severe head...
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passed out; dizzy; hit the ground; nausea; pain at injection site; fever; chills; tired; severe headache; vomiting x 2; cold; experienced orthostatic hypotension; This is a spontaneous report from a contactable other HCP. A 65-years-old female patient started to receive bnt162b2 (BNT162B2; Lot # EK9231) vaccine , intramuscular in the left arm on 07Jan2021 11:00 at single dose for Covid-19 immunisation . Medical history included rubber sensitivity (Latex). The patient's concomitant medications were not reported. On 09Jan2021 12:00 the patient experienced orthostatic hypotension , passed out with outcome of recovered , dizzy with outcome of recovered , hit the ground with outcome of recovered. These events were considered serious because medically significant. On 09Jan2021 12:00 the patient also experienced the following non serious events: nausea with outcome of recovered , pain at injection site with outcome of recovered , fever with outcome of recovered , chills with outcome of recovered , tired with outcome of recovered , severe headache on with outcome of recovered , vomiting twice with outcome of recovered , cold with outcome of recovered. The reporter stated the patient attempted to get out of bed and she passed and hit the floor. Caller states she think she may have experienced orthostatic hypotension. Caller stated if she had stayed in bed she probably would not have fallen. Her husband found her laying in vomit The patient underwent lab tests and procedures which included body temperature: 99.6 fahrenheit on unknown date.; Sender's Comments: Based on a chronological temporal association a causal relationship between events orthostatic hypotension , passed out dizzy and falling down and BNT162B2 vaccine cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 65 | 2021-01-20 | abdominal pain upper | Severe chills, fever, lower stomach pain, headache, injection site pain |
| 65 | 2021-01-20 | nausea |
Flushed face; Severe nausea; This is a spontaneous report from a contactable consumer (patient). A ...
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Flushed face; Severe nausea; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right arm on 11Jan2021 10:00 at single dose for COVID-19 immunisation. Medical history included hypertension and gastrooesophageal reflux disease. The patient previously took lisinopril and experienced drug hypersensitivity and anaphylactic reaction, diphenhydramine (BENADRYL) and experienced drug hypersensitivity and urticaria. Concomitant medication included propranolol hydrochloride (PROPRANOL), chlorthalidone (unknown manufacturer), rabeprazole sodium (ACIPHEX), vitamin c (unknown manufacturer). The patient experienced flushed face and severe nausea on 11Jan2021 13:00 with outcome of not recovered. It was unknown f treatment was performed. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19. Information on the Batch/Lot number has been requested.
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| 65 | 2021-01-20 | vomiting, nausea |
In less than 60 seconds, I became Diaphoretic, had substernal chest pain radiating to back, nausea a...
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In less than 60 seconds, I became Diaphoretic, had substernal chest pain radiating to back, nausea and eventual vomiting. This lasted for a long period of time, I asked to go to ER because I was so alarmed. I felt great all day prior to injection. I had been at work as a nurse with Mobile County Public School System, until I came to get vaccination .
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| 65 | 2021-01-21 | diarrhea, abdominal discomfort | HAD GI UPSET AND DIARRHEA |
| 65 | 2021-01-21 | diarrhea | fever 4 days later and diarrhea |
| 65 | 2021-01-21 | difficulty swallowing |
Angioedema, which consisted of tingling/pressure in lips, chin, roof of mouth, tongue, and pharynx; ...
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Angioedema, which consisted of tingling/pressure in lips, chin, roof of mouth, tongue, and pharynx; feeling of swelling and burning in throat; slight difficulty swallowing; hoarseness; pruritus
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| 65 | 2021-01-21 | nausea |
Patient began to experience nausea, dizziness, generalized weakness, and an elevated BP (209/101) ap...
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Patient began to experience nausea, dizziness, generalized weakness, and an elevated BP (209/101) approximately 5 minutes after receiving the 2nd dose of the COVID vaccine. The patient was taken to the emergency department for further workup. In the ED, the patient was given acetaminophen and ondansetron with resolution of all symptoms except generalized weakness and fatigue. Workup in the ED was negative, and the patient was discharged home.
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| 65 | 2021-01-21 | nausea | ACHES/ HEADACHE/ FATIGUE/ NAUSEA. LASTED UNTIL 1/14 AFTERNOON. TOOK ADVIL AND REST |
| 65 | 2021-01-21 | nausea |
Nausea on 1/19. Awoke on 1/20 with extreme muscle aches and fatigue, more nausea in evening, fatigu...
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Nausea on 1/19. Awoke on 1/20 with extreme muscle aches and fatigue, more nausea in evening, fatigue,. Got up on 1/21 still slightly achy but headache all day. Slept a great deal and took advil.
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| 65 | 2021-01-21 | nausea |
Approx 5.5 days after receiving her first COVID-19 vaccine, reporter developed a low-grade fever of ...
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Approx 5.5 days after receiving her first COVID-19 vaccine, reporter developed a low-grade fever of 99.1-99.4F, headache, light nausea, and fatigue. Noted profuse sweating upon waking on 1/21/21.
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| 65 | 2021-01-21 | nausea |
Patient began to experience nausea, dizziness, generalized weakness, and an elevated blood pressure ...
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Patient began to experience nausea, dizziness, generalized weakness, and an elevated blood pressure (209/101) approximately 5 minutes after receiving the 2nd dose of the COVID-19 vaccine. The patient was taken to the emergency department for further workup. In the ED, the patient was given acetaminophen and ondansetron. Workup was negative, and the patient was discharged home.
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| 65 | 2021-01-22 | nausea | Severe nausea, syncope, headache |
| 65 | 2021-01-23 | diarrhea |
Reported fever of 101 degrees F yesterday with joint pains and today diarrhea with continued joint p...
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Reported fever of 101 degrees F yesterday with joint pains and today diarrhea with continued joint pains. Has had BM five times already. Temp decreased to 100 degrees F. along with diarrhea and joint point
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| 65 | 2021-01-24 | diarrhea | Diarrhea Chills Muscle aches Extreme fatigue |
| 65 | 2021-01-24 | nausea |
At 53 hours after injection experienced piercing headache throughout different parts of head, face ...
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At 53 hours after injection experienced piercing headache throughout different parts of head, face and neck accompanied by nausea though no vomiting or fever. Tylenol did not touch it. Slept on and off. Lasted 24 hours and then disappeared.
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| 65 | 2021-01-24 | vomiting |
I had two shots one 12/30 and the other 1/20 had side effects from each. First shot fever, chills, e...
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I had two shots one 12/30 and the other 1/20 had side effects from each. First shot fever, chills, exhaustion for 4 days. shot given on Wednesday and not able to shower or get up till Sunday Second shot symptoms more severe. Headache, sick to my stomach vomited, and exhaustion same thing shot given on Wednesday and not able to get up till Sunday. First 24 hours of the second shot I was so weak I good not get up even to get a drink.
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| 65 | 2021-01-25 | nausea |
Headache not too bad but hot nauseated 24 hours after injection; Headache not too bad but hot nausea...
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Headache not too bad but hot nauseated 24 hours after injection; Headache not too bad but hot nauseated 24 hours after injection; Headache not too bad but hot nauseated 24 hours after injection; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284) intramuscular in the right arm on 11Jan2021 07:30 AM at a single dose for Covid vaccine. Medical history included high BP. The patient had no known allergies. Concomitant medications included lisinopril, colecalciferol (VITAMIN D), vitamin B complex (B COMPLEX), calcium, and cetirizine hydrochloride (ZYRTEC) (other medications in two weeks). The patient had no other vaccine in four weeks. The patient experienced headache not too bad but hot nauseated 24 hours after injection on 12Jan2021 08:00 AM. Treatment was not received for the events. The patient had no Covid prior to vaccination. She did not have Covid tested post vaccination. The outcome of the events was not recovered.
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| 65 | 2021-01-25 | vomiting | Vertigo and vomiting for about 1 hour on 1/26. A bit dizzy this am, but much better. |
| 65 | 2021-01-26 | abdominal discomfort, decreased appetite, nausea |
1/20/21: Headache; slight nausea with flip-flop stomach feeling; no appetite; sore arm injection are...
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1/20/21: Headache; slight nausea with flip-flop stomach feeling; no appetite; sore arm injection area 1/21/21: Lingering headache but only slight; sore arm injection area 1/22/21: Lingering sore arm but dramatically decreased
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| 65 | 2021-01-27 | nausea | Dizziness, nausea, headache, loss of taste |
| 65 | 2021-01-27 | nausea | Nausea, Continuous headache, Exhaustion for THREE days |
| 65 | 2021-01-28 | nausea |
Patient vaccinated @ 10:14 on 1/29/2021 then placed in observation for 30mins. At 10:19 c/o dizzines...
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Patient vaccinated @ 10:14 on 1/29/2021 then placed in observation for 30mins. At 10:19 c/o dizziness, shortness of breath, nausea, shaking. patient is clammy & pale, a&o x4, lungs clear bil all lobes, pulse normal, cap refill <3, V/S @ 10:20, b/p 140/90, r22, p72, t 99.7, unable to obtain o2 stat via pulse ox r/t pt shaking. Patient states that temp normal runs 96.8. Monitoring pt while obtaining health history. 10:40 V/S t 99.8, b/p 160/74, p113, 02 88% on RA, r 24, o2 placed on pt 15l nonrebreather, o2 91%. 10:50 EMS arrived, pt a&ox4, no change in condition, V/S 100/60, 100% on 15L nonbreather, p90, r22. 10:55 still nausea, 4mg sublingual zofran given. 11:04 pt transferred to stretcher with assisit, a&Ox4, V/s 132/69, p80, 94% o2 on 10l via nasal cannula, r26 co2 33. pt transferred via ambulance, pt request to be taken to hospital.
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| 65 | 2021-01-28 | vomiting | Terrible vertigo. Vomiting. Dizziness. Woke up with it have had it severely all day. |
| 65 | 2021-01-31 | abdominal pain |
Body aches, random shooting pains through body. Upper back pain, abdominal pain, severe coughing th...
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Body aches, random shooting pains through body. Upper back pain, abdominal pain, severe coughing that evening, headache, sore arm. Took Tylenol.
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| 65 | 2021-01-31 | diarrhea |
Diarrhea began 2pm on day of i hection. 1 episode. Then beginning 4:00a.m. Saturday morning the 30t...
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Diarrhea began 2pm on day of i hection. 1 episode. Then beginning 4:00a.m. Saturday morning the 30th. And I'm still having episodes today, February 1st.
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| 65 | 2021-02-01 | nausea |
headache; nausea; fatigue; sore arm; This is a spontaneous report from a contactable consumer report...
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headache; nausea; fatigue; sore arm; This is a spontaneous report from a contactable consumer reporting for herself. A 65-year-old female patient (not pregnant), received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283), via an unspecified route of administration, on left arm on 16Jan2021 14:15 at single dose for COVID-19 immunization. Medical history included Diverticulosis, hypothyroid, osteoarthritis, vitiligo, psoriasis, anxiety/depression, known allergies: Iodine, sulfa, bivalve shellfish, garlic, onions. Concomitant medications included first dose of pneumococcal vaccine polysacch 23v (PNEUMOVAX) on 23Dec2020 on left arm, celecoxib (CELEBREX), sertraline, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), levothyroxine sodium (SYNTHROID), liothyronine sodium (CYTOMEL). The patient experienced fatigue, sore arm the day after vaccine was administered on 17Jan2021. Two days after administration on 18Jan2021, patient experienced fatigue, headache, nausea. No treatment received for all events. The outcome of the events were resolving.
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| 65 | 2021-02-02 | diarrhea, nausea |
nausea, diarrhea, dizziness, aches & pains all over body, feeling weird, tired, can't get up, all l...
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nausea, diarrhea, dizziness, aches & pains all over body, feeling weird, tired, can't get up, all lasting 3 days
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| 65 | 2021-02-02 | diarrhea, vomiting | Projectile vomiting and diarrhea from 11:00 PM ? 4:00 AM, fever through late afternoon on Tuesday. |
| 65 | 2021-02-02 | diarrhea |
in addition to previous adverse events I reported, I failed to mention that my ears have a buzzing n...
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in addition to previous adverse events I reported, I failed to mention that my ears have a buzzing noise and it sometimes keeps me awake at night it is so loud. This happened immediately and is ongoing. Also, I had diarrhea the next day. See #280380 submission. I had spoken with others who had taken the Moderna vaccine, and they said they had no reactions to their vaccine. So, I was very taken off guard when I had the reaction approx 5 minutes after the vaccine was given. It was pretty scary.
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| 65 | 2021-02-02 | difficulty swallowing |
severe ringing to ears for four days; throat was a bit congested; difficulty of swallowing; somethin...
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severe ringing to ears for four days; throat was a bit congested; difficulty of swallowing; something stuck in the throat; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date: unknown), via an unspecified route of administration on 16Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient wanted to ask if it is normal to have severe ringing to ears especially in the morning. The patient received the COVID 19 vaccine last 16Jan2021. The patient reported symptoms which she has been experiencing for 4 days now with the COVID 19 vaccine, Pfizer's. She experienced severe ringing to ears for four days since 16Jan2021, it has been happening for four days, and usually happens in the morning and also, in Jan2021, there was something stuck in the throat, like her throat was a bit congested with difficulty of swallowing. The throat was being ok now, it's getting better, but the severe ringing to her ears was her main concern. The patient was recovering from the events "something stuck in the throat", "throat was a bit congested" and "difficulty of swallowing" while the event "severe ringing to ears for four days" had not resolved. Information on the lot/batch number has been requested.
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| 65 | 2021-02-04 | nausea |
fever, headache, bp 155/79 (usdually in 110's 120's/ baseline), and nausea. Caller wanted to know i...
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fever, headache, bp 155/79 (usdually in 110's 120's/ baseline), and nausea. Caller wanted to know if any interaction with APAP. Advised no interaction between Pfizer covid Vaccine and APAP, increase fluid intake as well, PIC will call back to f/u at later time.
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| 65 | 2021-02-04 | nausea |
a few hours after injection my arm was unusually sore past; my elbow chills that lasted for about 6 ...
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a few hours after injection my arm was unusually sore past; my elbow chills that lasted for about 6 hrs; temp of 100.6; body aches; nausea; This is a spontaneous report from a contactable consumer. A 65-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3302), via an unspecified route of administration in the left arm on 21Jan2021, at 08:00 a single dose for covid-19 immunization. Medical history included breast cancer stage one from Oct2019. There were no allergies to medications, food, or other products. Concomitant medication included rosuvastatin (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN), benazepril (MANUFACTURER UNKNOWN). The patient experienced the following event on 21Jan2021, at 03:00: a few hours after injection my arm was unusually sore past, my elbow chills that lasted for about 6 hrs, temp of 100.6, body aches and nausea. The patient underwent lab tests and procedures which included body temperature: 100.6 Fahrenheit on 21Jan2021. Details were as follows: a few hours after injection, the patient noted that her arm was unusually sore past elbow chills that lasted for about six hours. Temp of 100.6 body aches nausea. It was reported that treatment was not received for the events; however she used a heating pad to relieve the pain. The events were non-serious. No diagnosis of COVID-19 prior to vaccination was noted. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events, a few hours after injection my arm was unusually sore past, my elbow chills that lasted for about 6 hrs, temp of 100.6, body aches and nausea was recovered in Jan2021.
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| 65 | 2021-02-04 | nausea |
On 01/26/2021 I received my second dose of COVID vaccine. 02/04/2021 I awoke at 3am and could see ...
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On 01/26/2021 I received my second dose of COVID vaccine. 02/04/2021 I awoke at 3am and could see fine. At 7am I awoke again and was seeing double from my left eye. Was seen my an ophthalmologist and dx w 4th nerve palsy- Left eye. I have no underlying medical conditions to explain this, ie no diabetes, HTN etc.. At this time 02//05/2021 I continue to have double vision , the image is sloping downward, head movement and keeping my left eye open results in this woozy feeling of imbalance and nausea.
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| 65 | 2021-02-05 | nausea |
Vaccine 10 am- fine all day and evening. Awoke at 3:40 am and rolled off of arm where injection giv...
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Vaccine 10 am- fine all day and evening. Awoke at 3:40 am and rolled off of arm where injection given and a wave of pain and nausea and malaise overwhelmed me. I passed completely out still lying in bed (so out that I wet myself in bed) and gradually came to, still feeling horrible. Got up, changed clothes, and major chills when I returned to bed. Around 6am I felt nauseous, got up to vomit, but instead passed completely out on the bathroom floor for about 15 minutes. Remainder of day I felt very stiff, low energy and slightly woozy. By afternoon, energy was returning (I vacuumed the house). Minimal pain in arm this time compared to previous.
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| 65 | 2021-02-05 | nausea |
Soreness at injection site, Extreme chills and fatigue, beginning about 8am Feb 5, chills continued ...
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Soreness at injection site, Extreme chills and fatigue, beginning about 8am Feb 5, chills continued until evening but were not as bad in afternoon. Low grade fever, migraine and nausea began around 2:00. Woke up with migraine at 6:30 am on February 6 which has subsided since taking sumatritam. Some fatigue and lethargy this morning but ok otherwise
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| 65 | 2021-02-05 | vomiting, nausea | Vomiting Nausea Dizzy Possible seizure while sleeping |
| 65 | 2021-02-06 | diarrhea | Diarrhea 02/04/21;Headaches 02/04/22;Headaches 02/05/21;Headaches 02/06/21 |
| 65 | 2021-02-07 | abdominal pain upper, nausea, abdominal pain |
Severe Nausea- early morning. At night upon going to bed , severe stomach, abdominal and back pain. ...
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Severe Nausea- early morning. At night upon going to bed , severe stomach, abdominal and back pain. Lasted all night long - could not get into a position to lessen pain. Got out of bed in the morning and sat for a while. Went back to bed a couple hours later, propped myself up on bed, pain subsided after a couple hours. Spoke with the nurse at my doctors-she advised most likely effects from the second COVID shot
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| 65 | 2021-02-07 | decreased appetite |
Chills, headache, body aches, joint pain , neck and low back pain, eye and mouth pain, skin sore to ...
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Chills, headache, body aches, joint pain , neck and low back pain, eye and mouth pain, skin sore to touch all over, excessive tiredness, lethargy, loss appetite.
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| 65 | 2021-02-07 | nausea |
she used to be 6'2 but she thinks she has shrunk a little; nauseous/she is still just a little queas...
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she used to be 6'2 but she thinks she has shrunk a little; nauseous/she is still just a little queasy; tried to get out of bed, and the whole world tilted on her/everything turned upside down; sore arm; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EL1283), via an unspecified route of administration in the right arm on 17Jan2021 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included Breast cancer in 2003 or 2004, for which the patient was in three clinical trials following that time. The patient reported that she requested to have the vaccine administered into her right arm because she is a breast cancer survivor. The patient has no concomitant medications. The patient confirmed that she did not have any other vaccines on the same day as the COVID vaccine. The patient previously received Letrozole for breast cancer and provided that she has not taken letrozole or any or medications, not even vitamins, for the last three years. On 18Jan2021 the patient experienced sore arm, which was not severe per the patient. On 21Jan2021 at around 03:00, the patient was nauseous and when the patient tried to get out of bed, the patient felt like the "whole world tilted on her". The patient reported the same thing continued a few times when she tried to get up, she just couldn't because everything turned upside down. So the patient went back to sleep, and she got up at 11:00AM, and she feels much better now, and now she is just having a little bit of remaining queasiness, like she can't go on a run right now, she is not 100%. The patient inquired if these are known side effects of the product. The patient also reported that she that she used to be 6'2 but she thinks she has shrunk a little from an unknown date. The patient stated that her PCP was not aware that she received the vaccine. The clinical outcome of the sore arm was recovered on 19Jan2021. The clinical outcome of the nauseous/she is still just a little queasy, tried to get out of bed, and the whole world tilted on her, and thinks she has shrunk a little was unknown.
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| 65 | 2021-02-07 | nausea |
With the second does I experienced headaches . blurred vision I would not say that these are adverse...
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With the second does I experienced headaches . blurred vision I would not say that these are adverse events but I experienced nausea and chills. as well.
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| 65 | 2021-02-07 | nausea |
Woke up with vertigo. Felt dizzy, nauseated and cold. Around noontime this feeling had passed, alt...
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Woke up with vertigo. Felt dizzy, nauseated and cold. Around noontime this feeling had passed, although still feeling a bit sluggish.
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| 65 | 2021-02-08 | decreased appetite |
She felt same the way but worst; Lack of appetite; Passed out; Chills; Aches; Headache; Had no energ...
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She felt same the way but worst; Lack of appetite; Passed out; Chills; Aches; Headache; Had no energy; Tired; Feeling sick; She was shaky, cold; She was shaky, cold; She had the flu; This is a spontaneous report from a contactable consumer reporting for herself. A 65-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL1284), via an unspecified route of administration left arm single dose on 18Jan2021 17:30 for covid-19 immunisation. Medical history was none. There were no concomitant medications. No other vaccine was received in four weeks. The patient experienced passed out on 20Jan2021 14:00, tired on 18Jan2021 21:00, feeling sick on 18Jan2021 21:00, chills on 19Jan2021 09:00, aches on 19Jan2021 09:00, headache 19Jan2021 09:00, had no energy on 19Jan2021 09:00, lack of appetite on 22Jan2021 09:00, she was shaky in Jan2021, cold in Jan2021, she had the flu on Jan2021, she felt same the way but worst on an unspecified date. The outcome of the events was recovered on 22Jan2021
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| 65 | 2021-02-08 | diarrhea |
my body collapsed and I had a Pulmonary embolism/I have clot in my lung; I have behind my knee like ...
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my body collapsed and I had a Pulmonary embolism/I have clot in my lung; I have behind my knee like a deep wide black spot and it is hard; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medication included amlodipine, metformin and propranolol. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization and experienced severe headache and diarrhea. On 13Jan2021, the patient reported that: "my body collapsed, I had a pulmonary embolism. I had to go to the hospital in ambulance. When I was there, they find out that I have clot in my lung. I was in an intensive care for 2 days or 3 days and about 5 days in the hospital (from 13Jan2021 to 17Jan2021). I have behind my knee like a deep wide black spot and it is hard, my body did not have anything like that". Therapeutic measures were taken as a result of event pulmonary embolism/ clot in lung and included treatment with "some medications", one of which ELIQUIS. The patient outcome of pulmonary embolism and "clot in lung" was recovered on an unspecified date and of deep wide black spot was unknown. The information on the batch number has been requested.
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| 65 | 2021-02-09 | abdominal pain upper, nausea, diarrhea |
Stomach pain; Nausea; headache; Joint pain; did not feel good; more tired than usual; redness/arm wa...
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Stomach pain; Nausea; headache; Joint pain; did not feel good; more tired than usual; redness/arm was red; arm was hurting; arm red with a red bump; diarrhea; she has arthritis and her pain has gotten worse; This is a spontaneous report from a Pfizer-sponsored program. A nurse aide (consumer or other non hcp) reported for herself that the 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: E13302), intramuscular injection in the left arm on 20Jan2021 at single dose for COVID-19 prophylaxis. Medical history included ongoing arthritis from an unknown date. Concomitant medication included duloxetine hydrochloride (CYMBALTA) and ibuprofen for arthritis. The patient got the vaccination on 20Jan2021 and experienced redness, pain and nausea on an unspecified date in Jan2021. She said that that night (on 20Jan2021) and the next morning her arm was hurting and it was red with a red bump. On Thursday (21Jan2021) and Friday (22Jan2021), she felt joint pain, no fever, and did not feel good. The patient experienced more tired and did not feel good on 21Jan2021. The patient experienced headache on 23Jan2021. Saturday (23Jan2021) she was more tired than usual and on Sunday (24Jan2021) she was home and felt completely tired and had stomach pain, joint pain, nausea, headache, but did not have a fever. She was feeling the same today (on 25Jan2021) and worse. The patient said that her arm was not red anymore, but it still had a small bump. Stomach pain comes and goes. She stated that she had some diarrhea, but not much in Jan2021. Her nausea comes and goes as well. She said that it was like you want to throw up, but she had not thrown up. She said that you just know that something was not right. She said that her headache was like a heaviness on top of her head and forehead. She said that it was bothering her but it was not terrible. Next dose is due on 10Feb2021. The patient said that she worked in a facility with elderly people. She said that she has arthritis and her pain has gotten worse in Jan2021. She said that even with the medication. She did not take her medication until Thursday evening to see if she had any effects from the vaccine. She took Ibuprofen 800mg and CYMBALTA for her arthritis. She said that her tiredness had nothing to do with her medications. She said that it was very rare that she even had a headache. The reason that she called was to see if she should she do anything, is it safe for her to go back to work. Event Joint pain, more tired and did not feel good were reported as worsened. The outcome of event arm was red was recovered on an unspecified date in Jan2021. The outcome of events arm was hurting, arm with a red bump, diarrhea was recovering. The outcome of events Joint pain, did not feel good, more tired than usual, Stomach pain, Nausea, headache was not recovered. The outcome of the other events was unknown.
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| 65 | 2021-02-09 | abdominal pain upper |
On the 8th day after vaccine, I had 24 hours of stomach ache, chills, fatigue, headache, backache, h...
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On the 8th day after vaccine, I had 24 hours of stomach ache, chills, fatigue, headache, backache, hip ache, and then stomach ache for a few days, and then totally fine; On the 8th day after vaccine, I had 24 hours of stomach ache, chills, fatigue, headache, backache, hip ache, and then stomach ache for a few days, and then totally fine; On the 8th day after vaccine, I had 24 hours of stomach ache, chills, fatigue, headache, backache, hip ache, and then stomach ache for a few days, and then totally fine; On the 8th day after vaccine, I had 24 hours of stomach ache, chills, fatigue, headache, backache, hip ache, and then stomach ache for a few days, and then totally fine; On the 8th day after vaccine, I had 24 hours of stomach ache, chills, fatigue, headache, backache, hip ache, and then stomach ache for a few days, and then totally fine; On the 8th day after vaccine, I had 24 hours of stomach ache, chills, fatigue, headache, backache, hip ache, and then stomach ache for a few days, and then totally fine; This is a spontaneous report from a contactable nurse (patient). A 65-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 11Jan2021 14:00 at SINGLE DOSE on Right arm for covid-19 immunisation. Medical history was none. No-covid-prior-vaccination. No Known- allergies. Concomitant medication included atenolol (TENORMIN), clonazepam (KLONOPIN), sertraline hydrochloride (ZOLOFT), atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]). No-other-vaccine-in-four weeks. Since 19Jan2021, On the 8th day after vaccine, I had 24 hours of stomach ache, chills, fatigue, headache, backache, hip ache, and then stomach ache for a few days, and then totally fine. AE-resulted-in: [Doctor or other healthcare professional office/clinic visit]. No treatment received. Covid-test-post-vaccination: included Nasal Swab, Pixel by Labcorp, covid test date on21Jan2021 was Negative. The event recovered in Jan2021. Information about lot/batch number has been requested.
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| 65 | 2021-02-09 | decreased appetite |
feeling pretty bad/ feel awful; she doesn't want to eat; her back hurts; she's irritable; depressed;...
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feeling pretty bad/ feel awful; she doesn't want to eat; her back hurts; she's irritable; depressed; pain in the injection site; joint pain; muscle pain; fatigue; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL3247), via an unspecified route of administration on 19Jan2021 at a single dose for COVID-19 immunization. The patient thinks she could have COVID last Mar2020. She was not sure because her doctor's office was close for around a month and she couldn't get tested. There were no concomitant medications. On that day, 19Jan2021, after she received the vaccine she started feeling pain in the injection site, joint pain, muscle pain and fatigue. On 25Jan2021, she was feeling pretty bad, she doesn't want to eat, her back hurts, she's irritable and depressed. The patient would like to know if these side effects could be associated with the vaccine in someone who had the virus. She felt awful and she felt like she has gone right back to where she was 8 months ago, 10 months ago and started over with fatigue and everything. It was awful. She thinks she could have had COVID in Mar2020 and the symptoms she was having now, she had then and when she has had basically the whole time and that would just come back worse. There was no treatment received for the events. The outcome for the events was unknown.
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| 65 | 2021-02-09 | diarrhea |
Diarrhea; With the first one I had was severe headache; This is a spontaneous report from a contacta...
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Diarrhea; With the first one I had was severe headache; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on 18Dec2020 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included amlodipine (AMLODIPINE), lansoprazole (LANSOPRAZOLE), metformin (METFORMIN) and propranolol (PROPRANOLOL). The consumer stated, "I had this number to call. After I took the vaccine, the Pfizer vaccine on 18Dec2020, with the first one I had was severe headache on 19Dec2020 and I had some diarrhea on an unspecified date too. So, the headache started like from Saturday night sometimes until Monday and then after that it goes away, it went slowly but it goes away, severely, it was for two days." The outcome of the event headache was recovered on 21Dec2020 while the other event was unknown. Information about batch/lot number has been requested.
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| 65 | 2021-02-09 | nausea |
I felt dizzy; nauseated; This is a spontaneous report from a non-contactable consumer (patient). Thi...
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I felt dizzy; nauseated; This is a spontaneous report from a non-contactable consumer (patient). This 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL9261), via an unspecified route of administration on 20Jan2021 14:15 at single dose on the right arm for COVID-19 immunization. The patient medical history was none. No known allergies. The patient's concomitant medications were not reported. No other vaccine received in four weeks. Within 15 mins of being vaccinated, patient felt dizzy and nauseated. Patient believed these symptoms would have been less severe had she eaten something and drunk sufficient fluids prior to the injection. The symptoms went away within a couple of hours after eating and drinking. No COVID prior vaccination. No COVID tested post vaccination. No treatment received. Outcome of the events was recovered in Jan2021. No follow-up attempts are possible. No further information is expected.
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| 65 | 2021-02-09 | retching, vomiting, nausea |
On 01/30/2021 at 08:00 had an extreme headache. Then having extreme difficulty keeping my eyes open...
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On 01/30/2021 at 08:00 had an extreme headache. Then having extreme difficulty keeping my eyes open, like I was trying to drift off to sleep. Immediately there after, I started vomiting. These symptoms lasted 4 days extremely fast and hard. Tylenol was take for the headache and helped very little. I slept a lot and I couldn?t eat or drink anything witching vomiting it back up. Even my regular meds with a little water came back up. The evening of the 4th day, I was able to keep clear broth down and crackers helped with the nausea some. The following week, I still didn?t feel quite right and kept fighting off sleep. Today is the 10th of February and toe nausea has returned. Getting out of bed, I dry heaved for an hour. I feel if I eat anything it?s going to come back up. My theory is that the side effects didn?t go away the week I felt somewhat better and had resurfaced, starting out slowly like before. I called my primary at the VA and we discussed what I was already doing i.e. a bland diet until I feel better.
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| 65 | 2021-02-09 | vomiting, nausea |
vomited; chills; headache; had some itching, ongoing soreness and lump at site; had some itching, on...
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vomited; chills; headache; had some itching, ongoing soreness and lump at site; had some itching, ongoing soreness and lump at site; had some itching, ongoing soreness and lump at site; nauseous; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL9262), via an unspecified route of administration in the left arm on 22Jan2021 19:00 at a single dose for COVID-19 immunization. She takes thyroid daily (as reported) as it was removed when she was 20. The patient was not pregnant at the time of vaccination. The patient had no COVID prior to vaccination. The patient had not been tested for COVID post vaccination. The patient has not received any vaccine in 4 weeks. Concomitant medication included teriparatide (FORTEO) daily injection, diphenhydramine hydrochloride (BENADRYL). The patient previously took codeine and experienced allergies: codeine. The patient reported that no one knew if she should inject with teriparatide. On 22Jan2021, she received teriparatide at 4pm and bnt162b2 at 7pm. She took a diphenhydramine and had some itching, ongoing soreness and lump at site. She took teriparatide at 3:30pm at about 7pm she was nauseous and vomited. She had chills but felt better afterwards. She went to bed and have headache, not sure if she should discontinue teriparatide or discontinue before next shot. According to the reporter, the events started on 23Jan2021 19:00; vomited started on 23Jan2021 21:00. The outcome of the event was recovering.
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| 65 | 2021-02-09 | vomiting, nausea | Extreme headache, nausa,low grade fever, vomiting |
| 65 | 2021-02-09 | vomiting |
Headache; chills; fever; Vomiting; exhaustion; This is a spontaneous report from a contactable other...
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Headache; chills; fever; Vomiting; exhaustion; This is a spontaneous report from a contactable other healthcare professional. A 65-years-old female patient received bnt162b2 (BNT162B2; lot number=EL8982) second dose, via an unspecified route of administration on 20Jan2021 10:30 AM at SINGLE DOSE left arm for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing. No allergies to medications, food, or other products. Concomitant medication included venlafaxine hydrochloride (EFFEXOR) 75 mg for hot flasjes. Historical vaccine included first dose of Pfizer COVID 19 vaccine (lot number=EL1284) on 30Dec2020 10:00 AM at left arm for covid-19 immunisation. The patient experienced headache, chills, fever, vomiting and exhaustion, all on 20Jan2021 20:00 with outcome of recovered with sequelae (recovered with lasting effects). Reported as headache, chills, fever, vomiting, and exhaustion the exhaustion lasted more than 3 days and it was severe. Patient had reactions after each short. No treatment received for the adverse event. All events reported as non-serious. Patient was not pregnant at the time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient had not been tested for COVID-19.
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| 65 | 2021-02-10 | nausea, vomiting | Severe pain in left arm muscle-icing, Tylenol, Advil Headache Nausea, vomitX1 |
| 65 | 2021-02-10 | nausea | Sore arm nausea headaches chills fever |
| 65 | 2021-02-10 | nausea |
Flu like symptoms began 12 hours or so after injection: headache, lethargy, naseau, felt "unwell". ...
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Flu like symptoms began 12 hours or so after injection: headache, lethargy, naseau, felt "unwell". Symptoms continued for 3-4 days. Noted that I previously had COVID infection in April 2020 for which I was hospitalized for a week on oxygen.
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| 65 | 2021-02-11 | diarrhea, abdominal pain upper, nausea, flatulence |
Tues: sore arm, sore glands in neck, hurt to turn. Thurs. 2 am.started with Stomach cramps and di...
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Tues: sore arm, sore glands in neck, hurt to turn. Thurs. 2 am.started with Stomach cramps and diahrea also chills . Fri. Am stomach still not feeling great. Some cramping and gas and a little nausea. Feel cold
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| 65 | 2021-02-14 | abdominal discomfort |
Sore arm, slightly red at injection site. The shot hurt more than the first one. Had small waves of ...
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Sore arm, slightly red at injection site. The shot hurt more than the first one. Had small waves of stomach upset, headache, chills, lethargy but none lasted longer than an hour. All symptoms are gone now, 3 days later.
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| 65 | 2021-02-14 | diarrhea |
Diarrhea started Wednesday 2/10 and continues, headache Saturday 2/13, muscle aches entire body Sund...
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Diarrhea started Wednesday 2/10 and continues, headache Saturday 2/13, muscle aches entire body Sunday 2/14.
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| 65 | 2021-02-14 | nausea | tiredness, headache, muscle pain, chills, joint pain, nausea, feeling unwell |
| 65 | 2021-02-14 | nausea |
Swelling of tissue above and under eyes; Swelling of left cheek; Pressure in lymph nodes; Nausea; Th...
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Swelling of tissue above and under eyes; Swelling of left cheek; Pressure in lymph nodes; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264), via an unspecified route of administration in the right arm on 03Feb2021 at 12:00 (at the age of 65-years-old) as a single dose for COVID-19 immunization. Medical history included high creatinine levels and shellfish allergy; all from unknown dates and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included acetylsalicylic acid (BAYER ASPIRIN) and simvastatin (MANUFACTURER UNKNOWN); all taken for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Feb2021 at 13:00, the patient experienced swelling of tissue above and under eyes, swelling of left cheek, pressure in lymph nodes, and nausea; all serious for being life threatening. The patient was treated with diphenhydramine hydrochloride (BENADRYL). The clinical outcomes of swelling of tissue above and under eyes, swelling of left cheek, pressure in lymph nodes, and nausea were recovering.
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| 65 | 2021-02-14 | nausea |
Injection site soreness; headache (front of forehead across top of head all the way back to ears); s...
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Injection site soreness; headache (front of forehead across top of head all the way back to ears); sinus ache under eyes; muscle ache across shoulders; hint of nausea; early morning awoke to profuse sweating; tired.
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| 65 | 2021-02-15 | difficulty swallowing |
Waited 1/2 hour and left. On way home, 10 minutes out, throat started to close up. Took 25 mg of ...
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Waited 1/2 hour and left. On way home, 10 minutes out, throat started to close up. Took 25 mg of Benadryl and got home. Could talk and breath ok but increasingly difficult to swallow.
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| 65 | 2021-02-15 | nausea |
She was eating after the vaccine which started as a stiffness, down both of her shoulders and into h...
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She was eating after the vaccine which started as a stiffness, down both of her shoulders and into her waist, severe nauea and headache. She felt like her feet were in cinderblocks. She took some Tylenol, and woke up at 4:00 AM and had two severe headaches and nausea since Sunday. That night she felt as though she could not stand it any longer. Went to UC and they tested her for the virus which was negative, and still having symptoms. She thought the symptoms would get less, but it has been quite a few days. She takes a short walk and the intense pain in her arms, and legs are terrible. Her PCP told her that there was nothing they could do, and what she had been doing what she needed to do. They also told her to go back to UC if she did not improve.
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| 65 | 2021-02-15 | nausea | Low grade fever Nauseated Headache |
| 65 | 2021-02-18 | abdominal discomfort, blood in stool |
Blood in stool; Stomach discomfort; This is a spontaneous report from a contactable consumer reporti...
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Blood in stool; Stomach discomfort; This is a spontaneous report from a contactable consumer reporting for herself. A 65-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer BioNTech, Lot# FL9264), via an unspecified route of administration, on 04Feb2021 at 13:00, at single dose, for COVID-19 immunisation. Medical history was none. Concomitant medications were not reported. Patient did not have vaccinations within 4 weeks prior. The patient experienced blood in stool and stomach discomfort both on 05Feb2021 with outcome of recovering.
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| 65 | 2021-02-18 | diarrhea |
Day one after vaccine, swelling and soreness of the arm that was vaccinated. 10 days after the vac...
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Day one after vaccine, swelling and soreness of the arm that was vaccinated. 10 days after the vaccine: muscle aches, hand/wrist swelling and pain, and diahrrea on day 13. This has lasted 3 days and has started to subside with the use of ibuprofen every 4 hours. Reported to Dr. on Day 12.
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| 65 | 2021-02-18 | nausea, vomiting |
I got up around 9:00 am and felt weak. I ate breakfast and began to feel achy and nauseous so I went...
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I got up around 9:00 am and felt weak. I ate breakfast and began to feel achy and nauseous so I went back to bed. For the rest of the day I experienced: Feaver 102.4 Feaver 100.6 Severe vomiting 3x chills sweats body aches pain behind my eyeballs headache extreme weakness I continued to rest and take Tylenol all day to break the fever. The next morning, 2/17/2021 I woke up with a fever of 100.4 and took Tylenol. All other symptoms were gone by 2/17 except for low grade fever and fatigue. Fatigue continues still as of this reporting 2/19/21
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| 65 | 2021-02-18 | nausea, vomiting |
Woke up morning after with headache. By noon was nauseous and began throwing up. Threw up for 10 hou...
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Woke up morning after with headache. By noon was nauseous and began throwing up. Threw up for 10 hours.
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| 65 | 2021-02-18 | nausea |
1 PM I received the vaccine and withing 5 minutes had a slight pain on the left side of my head whic...
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1 PM I received the vaccine and withing 5 minutes had a slight pain on the left side of my head which then continued to a pain in my neck. also left side, then back pain, then slightly short of breath. I remained in the waiting area for over a half hour and felt no worse, but did report it to the young woman at the exit who said that was odd and seemed the kind of response with the second dose. I presumed it might be due to my already having antibodies. As I continued my day those symptoms quickly dispersed and I felt fine, albeit with a light soreness at the site on my left arm. At approximately 6pm I felt very fatigued and rested until 10pm, when I began to have chills, a headache and nausea. My left arm was also so sore I could not lay comfortably. I took Tylenol and aspirin both at 11:30 pm and attempted to sleep, which was fitful and disturbing. I had strange neurological events, such as odd visions in my half sleep and bizarre semi dreams but could not waken. At 4:00 AM I finally was able to pull out of this state and the last thing in my mind was a conversation with someone trying to explain what was happening to me, in my mind not vocal, that was in Italian. That is my second language. All day I had unwanted words, ideas etc. floating about in my brain. I could no longer sleep and was very weak, had terrible head and body aches and my legs also ached terribly. I was also slightly nauseous.These were all symptoms, minus the disturbing neurological one, that I had with Covid. I was too weak to leave the bed until much later in the day. I am still having effects but much less and I am at the 72 hour mark. I remained at rest all day and ran a low fever, then again a fever
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| 65 | 2021-02-18 | nausea |
Patient expressed to Clinical Site RN that she was feeling nausea and flushing 15 minutes after admi...
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Patient expressed to Clinical Site RN that she was feeling nausea and flushing 15 minutes after administration of COVID vaccine. Upon assessment, patient's blood pressure was 187/110. Patient began to develop rash across chest and arms. Mobile response called and patient was escorted to ED.
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| 65 | 2021-02-18 | retching, diarrhea |
Extreme dizziness Diarrhea Dry heaves Tingling in arms and legs Extremely weak Chills and hot Hus...
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Extreme dizziness Diarrhea Dry heaves Tingling in arms and legs Extremely weak Chills and hot Husband cared for me. Spoke to nurse at my doctor?s office. Water. Eventually bland food. Condition improving. She told me to go to ER if extreme dizziness recurs.
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| 65 | 2021-02-18 | vomiting, nausea |
Dizziness started early afternoon and got worse thru evening, when nausea began. At about 11:00 PM,...
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Dizziness started early afternoon and got worse thru evening, when nausea began. At about 11:00 PM, I vomited 4 times. After that, shaking chills set in. I did not take anything for it. When I woke up the next morning, I felt fine.
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| 65 | 2021-02-21 | nausea, diarrhea |
Feeling mostly normal but tired fell asleep at 11PM day of second vaccine. Woke up 1 hour later and...
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Feeling mostly normal but tired fell asleep at 11PM day of second vaccine. Woke up 1 hour later and got up to go to the bathroom but felt fine. Went out to the hall bathroom so as not to wake husband in Master bath. Urinited and got up slowly as I always do and walked out to the hallway to go back to bed. I lost consciousness and came to when my husband who heard a thud came and found me out having fallen down the stairs.. head on the landing and feet above the landing. I have no recollection of it once leaving the bathroom and i would have headed away from the stairs which was just to the left of the bathroom doorway. I didn't feel any pain. Later found a bump on my forehead of the right side of my face and a bruised lip. He said my back was wet with sweat and I took a couple minutes to come to. After returning to the bed.. i immediately had to empty bowels. Diarrhea.. then the rest of the night in Chills. No fever. Slept most of the next day and night. Headache and joint aches and swelled lymph nodes in neck.. Fatigue through 20th. Mostly better by the 21st. Still today on 22 I am being careful when going from prone to standing. I feel more head pressure getting up and maybe I notice a little nausea when rising. I may just be worried about fainting again. It has never happened to me before. I do have very good blood pressure on the lower side so I was always careful to get up slowly but never fainted. Neck is sore.. Not sure if lymph nodes or something to do with fall.
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| 65 | 2021-02-22 | nausea |
78 hours after injection I got dizzy and had fairly severe vertigo , nausea and threw up 4 times. I ...
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78 hours after injection I got dizzy and had fairly severe vertigo , nausea and threw up 4 times. I felt hot and chilled... I am not sure it was related to the injection. It resolved on sat Feb 20th 2021. I still have mild nausea but am on Ozempic which gives me nausea some of the time. I did not feel well but finally fell asleep and slept until AM.
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| 65 | 2021-02-23 | decreased appetite, nausea |
Shaking from being cold. Chills, left ear pain, nausea, very tired and rundown fir 3 days afterwar...
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Shaking from being cold. Chills, left ear pain, nausea, very tired and rundown fir 3 days afterwards. Couldn?t eat for / days afterwards. Bad dry cough still persists now 2 weeks later. Took Tylenol nothing helps the dry cough
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| 65 | 2021-02-23 | diarrhea |
pfizer jan 29 pfizer feb 19 Pfizer #1 EL 9263 Pfizer #2 EL 9267 low grade fever of 99.0, palpitatio...
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pfizer jan 29 pfizer feb 19 Pfizer #1 EL 9263 Pfizer #2 EL 9267 low grade fever of 99.0, palpitations, and diarrhea yesterday. Recommended that she see her primary provider if symptoms worsen.
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| 65 | 2021-02-23 | diarrhea | 1 day of fever, chills and bad diarrhea |
| 65 | 2021-02-23 | nausea | Almost immediate nausea, light headed, elevated blood pressure, arm pain |
| 65 | 2021-02-23 | vomiting, abdominal pain |
sudden onset severe mid abdominal pain x hours, one episode of vomiting, then persistent pain which ...
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sudden onset severe mid abdominal pain x hours, one episode of vomiting, then persistent pain which then also radiated to back. Whole episode lasted about 12 hours.
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| 65 | 2021-02-24 | decreased appetite |
No discomfort until 2:00 a.m. on 2/11. Woke up in intense pain in right arm, shoulder, front right ...
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No discomfort until 2:00 a.m. on 2/11. Woke up in intense pain in right arm, shoulder, front right bodice, up the back of my neck and head on only the right side. I took Tylenol, placed hot packs on the area and drank fluids. I took Advil at 4:00 a.m. Fell asleep and woke up at 8 a.m. I had no temperature but headache was intense. I ate a small breakfast and stayed quiet with hot packs on all areas - 5 p.m. I was feeling much better - went to bed at 7:00 p.m. next morning I was ok.
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| 65 | 2021-02-24 | nausea | Tiredness, headache, muscle pain, chills, fever, nausea, feeling unwell |
| 65 | 2021-02-24 | vomiting, nausea |
Monday, February 22, in the evening, I started feeling lightheaded, then more debilitating dizzy, ...
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Monday, February 22, in the evening, I started feeling lightheaded, then more debilitating dizzy, worsening, nauseas . Went home from work that evening around 9:30 p.m. I Vomited as soon as I got home. Felt better but still lightheaded, dizzy, not as bad. No fever. Couldn't sleep. Tuesday, February 23 felt pretty weak, tired some lingering lightheadedness. Stayed home from work. Next day, Wednesday, my right arm around the injection site was pretty sore. Hard to sleep last night. Took Tylenol for arm. Still somewhat sore today, Thursday.
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| 65 | 2021-02-25 | difficulty swallowing |
anaphylactic reaction; having issues breathing/didn't have normal respiratory support; swallowing, w...
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anaphylactic reaction; having issues breathing/didn't have normal respiratory support; swallowing, weakness, unable to take anything by mouth/had lost ability to swallow; swallowing, weakness, unable to take anything by mouth; affected my lungs, gut, muscles, everything.; still having lung issues; This is a spontaneous report from a contactable consumer(patient). A 65-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number RM9809), via an unspecified route of administration on 03Feb2021 at the 65 years old at single dose for COVID-19 immunization. The medical history included Muscular dystrophy. The concomitant medications included unspecified multiple medications. The patient received the first dose on 03Feb2021. Immediately after the vaccine on 03Feb2021 she had an anaphylactic reaction, received an Epipen, went to the ER was given steroids and sent home. Next day, still having symptoms, received second Epipen administration, went to Urgent Care, was admitted to hospital 04Feb2021. The patient stated she had a history of muscular dystrophy. She stated she was having issues breathing, swallowing, weakness, unable to take anything by mouth, didn't have normal respiratory support in Feb2021. It had affected her lungs, gut, muscles, everything. She may leave here on hospice. She wanted to know if there were others who had reported side effects such as hers. She had anaphylactic reaction to the mineral. She was still in the hospital. She had lost ability to swallow and she was still having lung issues in Feb2021. She was a disabled rehab healthcare worker. She did not have an address right now in the hospital but if sent her something later once she get out she will be able to do that but she did not have it now. She takes multiple medications. Right now she cannot take medications she need orally. She had gone to hospital getting meds via primarily IV. She had acute anaphylactic reaction immediately after the vaccine and went by ambulance to hospital and was given steroids, care basically and sent home and she still had issues the next day and it kept going from home to urgent care to admission at the hospital. She had done lot of lab tests in Feb2021. She was very concerned that this was not going to be a temporary issue. She had form of muscular dystrophy and now what was happening was the week before she got the vaccine totally independent in her home, feeling ok, medications okay and now she was at IV medications not being able to swallow. She talked to someone yesterday and they told she should be calling and reporting what happened and that was why she had been on the phone all day. She just want make sure she did not feel like the healthcare was reaching out to their own vaccination department and she want to make absolutely sure that not only does Pfizer know that have a horrid reaction but she want the healthcare firm that she had a horrid reaction and she want the CDC to know that she had a horrid reaction because right now she would tell all her friends with the severe form of muscle dystrophy she had not going to be vaccinated even though the researchers were telling her to get vaccinated. It was going to take a while to stop the efficacy again and having to be on the phone everyday when she was barely breathing. The patient underwent lab tests and procedures, which included Lab test unknown result in Feb2021. The outcome of the events was unknown.
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| 65 | 2021-02-25 | difficulty swallowing |
On February 23 (1 week after 2nd vaccine), I experienced sudden onset of swollen lymph node in left ...
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On February 23 (1 week after 2nd vaccine), I experienced sudden onset of swollen lymph node in left side of neck and sore throat, headache, difficulty swallowing, fatigue, some sinus symptoms and stuffy ears. Today is February 26 and I am still experiencing the same symptoms, somewhat less intense than initially. I called my primary care doctor's office and was told by the receptionist that this was a reaction to the vaccine and should subside in a few days and if not to call back.
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| 65 | 2021-02-25 | nausea, vomiting, diarrhea |
15 minutes after vaccination: stomach queasy and burning in esophagus 12 hours after vaccination: v...
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15 minutes after vaccination: stomach queasy and burning in esophagus 12 hours after vaccination: vomiting and diarrhoea and sore arm
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| 65 | 2021-02-26 | diarrhea | Diarrhea |
| 65 | 2021-02-26 | nausea, abdominal pain, vomiting |
Once day after receiving 2nd COVID Vaccine developed diffuse abdominal pain and Intractable nausea w...
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Once day after receiving 2nd COVID Vaccine developed diffuse abdominal pain and Intractable nausea with vomiting.
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| 65 | 2021-02-27 | nausea |
103.1 Fever, Extreme Migraine Headache, Chills, Extreme Body Aches, fatigue, Nausea and on second da...
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103.1 Fever, Extreme Migraine Headache, Chills, Extreme Body Aches, fatigue, Nausea and on second day: 101 fever, chills, terrible fatigue and a red rash over entire body.
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| 65 | 2021-02-28 | abdominal pain |
Body aches/random shooting pains throughout body; Fatigue; Upper back pain; abdominal pain; severe c...
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Body aches/random shooting pains throughout body; Fatigue; Upper back pain; abdominal pain; severe coughing that evening; headache; very sore arm; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EK9231), via an unspecified route of administration on the right arm on 14Jan2021 08:30 at a single dose for COVID-19 immunization at a hospital. Medical history included very chemically sensitive and drug sensitive, interstitial lung disease, and interstitial cystitis. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medication included vitamin D, zinc, and an unspecified thyroid medication. On 14Jan2021 13:00, the patient experienced body aches, fatigue, random shooting pains throughout body, upper back pain, abdominal pain, severe coughing that evening, headache, and very sore arm. Treatment included self prescribed paracetamol (TYLENOL). Since the vaccination, the patient has not been tested for COVID-19. The patient has not yet recovered from the events.
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| 65 | 2021-02-28 | decreased appetite |
shaking; chills; loss of appetite; fever; joint pain; headache; This is a spontaneous report from a ...
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shaking; chills; loss of appetite; fever; joint pain; headache; This is a spontaneous report from a non-contactable consumer. A 65-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: not available/provided to reporter at the time of report completion), via an unknown route of administration on 25Jan2021 at 10:00 AM at a single dose at the age of 65 years old for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included levothyroxine sodium (SYNTHROID). Historical vaccine included at the age of 64 years, first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in Dec2020 for COVID-19 immunization. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. On 25Jan2021 at 22:00, after receiving 2nd dose of COVID-19 vaccine in morning, patient experienced chills, shaking, fever, joint pain, loss of appetite, and headache later that evening. She stayed home from work for 2 days and felt better 48 hours later. The reporter assessed the events as non-serious. No treatment was received in response to the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown since the vaccination, if patient was tested for COVID-19. The patient recovered from the events on an unspecified date in Jan2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 65 | 2021-02-28 | difficulty swallowing |
Difficulty swallowing, chest discomfort severe about 6 hrs day of vaccine lingering difficulties t...
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Difficulty swallowing, chest discomfort severe about 6 hrs day of vaccine lingering difficulties throught 3 days .continued . saw dr. march 1st soft foods for now
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| 65 | 2021-02-28 | vomiting, nausea |
Within a couple hours I had nausea my are hurt and I just didn't feel good. I woke up in the night w...
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Within a couple hours I had nausea my are hurt and I just didn't feel good. I woke up in the night with fever, chills, bad headache and body aches head to toe. Took Tylenol. Woke in the morning with fever (101.8), chills, bad headache, body aches head to toe, joint aches and nausea. Took Tylenol. Too sick to get up all of Saturday. Saturday afternoon vomited. Saturday evening fever broke and began feeling a little better. Sunday still had a bad headache, body aches and joint aches. Today, Monday, feeling better but still have a mild headache, body aches and joint aches. I also feel really week and tired.
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| 65 | 2021-03-01 | abdominal pain upper |
Started having stomach pain less than 24 hours after my Second vaccine. It?s been 3 days and I am s...
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Started having stomach pain less than 24 hours after my Second vaccine. It?s been 3 days and I am still having issues.
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| 65 | 2021-03-01 | diarrhea, abdominal pain upper, vomiting, abdominal discomfort |
patient started feeling dizzy and sweaty about 5 minutes after vaccine given and was sitting in cha...
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patient started feeling dizzy and sweaty about 5 minutes after vaccine given and was sitting in chair and falling to the side. I tried talking to her and getting her attention and she would look at me and then close her eyes like she was going to pass out. She started talking to me and after a couple minutes then began to complain about a sick stomach and started vomiting and diarrhea on and off for about an hour. Patient would seem to feel better but then vomit again. After about an hour she had us call her daughter to come get her to take her home. Daughter came to get her and she was still complaining her stomach hurt. I called patients daughter a few hours later and she said her mom was still feeling sick and I told her to call her doctor or take her to the ER if she didn't start feeling better soon.
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| 65 | 2021-03-01 | nausea | Fever, chills, joint and muscle pain, headache, nausea, exhaustion,dizziness |
| 65 | 2021-03-01 | nausea |
Fever 100 - 101.5 24+ hours Chills 3.5 hours at noon 2-28, dizziness, nausea 2-3 hours one episode s...
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Fever 100 - 101.5 24+ hours Chills 3.5 hours at noon 2-28, dizziness, nausea 2-3 hours one episode syncope with fall, no injury extreme lassitude 24 hours
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| 65 | 2021-03-02 | diarrhea, nausea |
Pronounced pain at injection site started around 6pm, the day of the shot, 3/2/2021. After 8pm, sta...
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Pronounced pain at injection site started around 6pm, the day of the shot, 3/2/2021. After 8pm, started going downhill with chills and some sneezing. Managed to get to sleep, but woke up at 1:15 am and could not get back to sleep. Feeling chilled all night. At 5:30 am, got out of bed to take Tylenol and experienced dizziness (briefly blacked-out), sweats, nausea (vomited) and slight diarrhea. After that episode, started to feel a little better, though still a bit woozy and exhausted from lack of sleep.
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| 65 | 2021-03-02 | diarrhea |
Low grade fever; headache; cough; fatigue; diarrhea; This is a spontaneous report from a contactable...
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Low grade fever; headache; cough; fatigue; diarrhea; This is a spontaneous report from a contactable consumer (patient). This 65-year-old female received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3247) via an unspecified route of administration on 28Jan2021 at 14:30 (at the age of 65-years-old) as a single dose in the right arm for COVID-19 immunization. The patient had no medical history (as reported). The patient was not pregnant at the time of vaccination. Prior to vaccination the patient was diagnosed with COVID-19 on an unspecified date. Concomitant medications included levothyroxine from an unspecified date for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient did not have any allergies to medications, food, or other products. On 01Feb2021, the patient experienced low-grade fever, headache, cough, fatigue, and diarrhea. The events were reported as non-serious. The patient did not receive any treatment for the events. The patient was not hospitalized for the events. The outcomes of low-grade fever, headache, cough, fatigue, and diarrhea were recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
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| 65 | 2021-03-02 | nausea |
Nausea; Dizziness; she feels like the whole house is turning around; slight headache; Chills; overal...
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Nausea; Dizziness; she feels like the whole house is turning around; slight headache; Chills; overall tiredness; overall not feeling good; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262, expiration date: May2021), via an unspecified route of administration on the left arm on 29Jan2021 09:49 at single dose for COVID-19 prophylaxis. Medical history included ongoing hypertension (Stated that it is under control with her medication), prevent heart attack, high cholesterol, hepatitis B in 1996, Rubella/measles in 1996. Concomitant medication included ongoing acetylsalicylic acid, ascorbic acid (ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]) to prevent heart attack, hydrochlorothiazide, losartan potassium (LOSARTAN/HCTZ), simvastatin for high cholesterol. The patient previously took Flu shot for flu vaccination. She stated that she has had adverse events to previous vaccines. She stated that she had a rash and feeling bad. Profuse bleeding with her menses and stated that it lasted a week. Whenever she takes the Flu shot it disrupts her system for a while. Patient also previously took Hepatitis B in 1996 and a booster in 1997, Rubella/measles in 1996 and a booster in 1997, Tdap in 1996, OPV in 1996, Polio in 1996, TD 0.5mg in 2006. The patient experienced chills and overall tiredness on 29Jan2021; slight headache on 30Jan2021; nausea, dizziness and she feels like the whole house is turning around on 31Jan2021. Patient reported that she received the vaccine on Friday 29Jan2021 and said that she has had most of the events that were reported. Patient reported that she had chills, overall tiredness, nausea, slight headache, and overall not feeling good, like unwell feeling. She said that she had dizziness too. She said that she was wondering if she should call the doctor also. She was hoping her symptoms would go away. She said that she feels awful. She said that she feels like the whole house was turning around. She said that she cannot even drive. She said that she had a little bit of soup for lunch and she was nauseous. She said that she took Benadryl after she got home from getting the injection because she was not feeling good. She stated that she went to bed and slept and felt good when she woke up and said that feeling good was short lived. Chills: She said that she had to sleep with 2 layers of clothes. Noticed the chills at 9-10 pm that evening. She stated that she is still feeling chilly, but reported that the temperature is chilly outside. Tiredness: Started that evening after she received the vaccine. She said that she can still work, but she can hardly concentrate. She has to use a lot of focus to get the tasks done. Nausea: She noticed the nausea on Sunday. Slight Headache: She noticed the headache on Saturday 30Jan2021 and said that last night she had to take a Advil for her headache. Overall not feeling good: She thought it would have improved, but it is still there as of today. She said that she just wants to rest and she feels tired. Dizziness: Dizziness started yesterday 31Jan2021 and stated that it was awful yesterday. Patient said that it has slightly improved. The patient was recovering from chills and dizziness; not recovered from slight headache and nausea; unknown outcome for she feels like the whole house is turning around.
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| 65 | 2021-03-02 | nausea |
Severe headache, joint pain, nausea, muscle pain, tiredness, chills with second shot. four days la...
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Severe headache, joint pain, nausea, muscle pain, tiredness, chills with second shot. four days later: itching, redness and welts on over both elbows, knees and ankles.
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| 65 | 2021-03-03 | nausea | Nauseous, pain at injection site, fatigued, feeling unwell. |
| 65 | 2021-03-04 | diarrhea, nausea |
nausea; diarrhea; Could not lift her head because her eyes were hurting. When she opened them it gav...
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nausea; diarrhea; Could not lift her head because her eyes were hurting. When she opened them it gave her a headache; Feeling cold; chills; muscle pain; joint pain; fever; headache/Headaches was reported as worsened; Tiredness; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient (also the age at vaccination) receive the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9263), via an unspecified route of administration at the left arm on 26Jan2021 11:00 AM SINGLE DOSE for covid-19 immunization (reported also as To protect herself). Medical history included that she had a heart cath under anesthesia about two weeks prior to getting the vaccine. She clarifies it was on 30Dec2020. There were no concomitant medications. There was no additional vaccines administered on same date. There was no prior vaccinations (within 4 weeks). No family medical history relevant to AE(s) reported. The patient was vaccinated at a Clinic. The patient previously had a flu shot in Oct2020 and the shingles vaccine in Aug2020 (for immunization). It was reported that the patient had headache, fever, chills, muscle pain, joint pain, nausea and diarrhea after the first dose of the pfizer covid 19 vaccine. The patient wanted to know how long these side effects will last. It was also asked if she should get the second dose of the covid 19 vaccine because she had side effects to the first dose and if the side effects to the second dose or worse than the first dose. It was further reported that the patient got her first shot last Tuesday (26Jan2021). Starting Friday (29Jan2021) she got symptoms. Should she be concerned? She has had tiredness, headaches, (on 27Jan2021) and this morning (01Feb2021) she could not lift her head because her eyes were hurting. When she opening them it gave her a headache. She also had muscle and joint pain (on 29Jan2021) and chills (on 30Jan2021) and fever (on 28Jan2021). She got so cold she covered up with blankets and fell asleep (on 01Feb2021). Then when she woke up it was gone. How long should these side effects last? Should she be concerned? Should she contact her doctor? The reporter also says that most of her symptoms started Friday 29Jan2021. Then she clarifies that actually her symptoms started small before then, on Wednesday 27Jan2021. As the week went on more symptoms came and became other things. It was added that she felt like Friday 19Jan2021 is when she felt the infusion all of a sudden hit her body. That is when she felt the virus hit her with symptoms. Right now her head still hurts. She is not taking as many Tylenol or staying on it regularly like she was. Maybe she should do that again. Could not lift her head because her eyes were hurting. When she opened them it gave her a headache: She says she still has dull pain behind her eyes. She no longer has chills but is feeling cold (on 01Feb2021). Like she chest was frozen on the same side that she got the shot in. They told her to take Tylenol to get relief. But she got concerned as the days went on. She is supposed to get the second dose on 16Feb2021. It was added that it was unknown specific times that these occurred. Friday she would say that she felt it all hit her bad around 11 AM after lunch. The outcome of the event headache, Muscle and joint pain was not recovered; for the event Could not lift her head because her eyes were hurting. When she opened them it gave her a headache and Feeling cold were recovering; for the event nausea, fatigue and diarrhea was unknown; and recovered for the events Chills on 31Jan2021, Fever on 29Jan2021. The AE(s) did not require a visit to Physician office nor ER. Case was considered as non-serious.
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| 65 | 2021-03-04 | indigestion |
Client c/of heartburn and dryness to back of throat. Client seen and assessed by EMT and Vitals are...
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Client c/of heartburn and dryness to back of throat. Client seen and assessed by EMT and Vitals are: B/P 156/90, HR 89, O2 99. Client continued being monitored for30 min. and cleared by EMS after she stated that she no longer felt sensation.
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| 65 | 2021-03-04 | nausea, vomiting |
very bad nausea; Throwing up mucus 5 times last sat.; 99.1 temp; dizzy/ think the dizziness was for...
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very bad nausea; Throwing up mucus 5 times last sat.; 99.1 temp; dizzy/ think the dizziness was for the need of a blood transfusion, which I got Tues after vaccine; head ache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration (at the age of 65-years-old) on 28Jan2021 10:30 at a single dose in right arm for COVID-19 immunization. Medical history included anemia with blood transfusions, fat, diabetic, constipation, sinus, and manic depression, allergies, immune compromise. Concomitant medication included cyclosporine, lithium, metformin, omeprazole (OMPRAZOLE), paroxetine hydrochloride (PAXIL [PAROXETINE HYDROCHLORIDE]). The patient reported, "I am immune compromise. I have had some of these health complaints ongoing. The vaccine made the problems worst. Can you tell me what the 2nd dose will do to me? I think the dizziness was for the need of a blood transfusion, which I got Tues after vaccine." The patient experienced very bad nausea, throwing up mucus 5 times last Sat., 99.1 temp, dizzy/ think the dizziness was for the need of a blood transfusion, which I got Tues after vaccine, head ache; all on 30Jan2021 with outcome of not recovered. The patient underwent lab tests and procedures which included body temperature: 99.1 on 30Jan2021, SARS-CoV-2 test: negative on 01Feb2021. Unknown if treatment received for the adverse events. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse events resulted Emergency room/department or urgent care. The case was assessed as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 65 | 2021-03-04 | nausea, vomiting |
Six days after receiving my second vaccine at a mass drive-thru site (on 2/25), I experienced plugge...
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Six days after receiving my second vaccine at a mass drive-thru site (on 2/25), I experienced plugged ears -- a feeling of congestion, pressure and mild pain. Then three days after that, on 2/28, I became dizzy and nauseous, causing vomiting and a feeling that I may faint. My husband took me to Urgent Care where I was diagnoses with BPPV and prescribed meclizine and ondansetron. I have been doing the Epley maneuver and my condition has improved somewhat, but I still feel fatigued and the pressure in my ears has not subsided. I cannot hear correctly out of my left ear. I am concerned that I now have Meniere's disease, which can be caused by "abnormal immune response" -- the vaccine? I have an appointment with an ENT specialist on 3/25 and hopefully can get some answers at that time.
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| 65 | 2021-03-07 | diarrhea | Headache within 1 hour chills diarrhea Lasted til 10 P M. Felt fine next day |
| 65 | 2021-03-07 | nausea | Headache, chills, nausea, fatigue, soreness at injection site |
| 65 | 2021-03-07 | nausea |
slept from Friday pm through Saturday about 2pm,exhausted, slept until 10am Sunday. nightmares, mi...
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slept from Friday pm through Saturday about 2pm,exhausted, slept until 10am Sunday. nightmares, minor sweating. on Sunday began nausea, headache, neck and shoulder aches, fluish, minor sore throat. knew I would sleep heavily again and did.
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| 65 | 2021-03-07 | vomiting |
High Blood Preaseure 183/79, headache, disorientation, temporary forgetfulness, vomit. All these hap...
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High Blood Preaseure 183/79, headache, disorientation, temporary forgetfulness, vomit. All these happened around 9:00 p.m. As soon as those signs appeared we rushed her to the ER. The results showed Brain bleed. She was transfered to Hospital where she was valorated again and other series of test were performed. On Tuesday, 02/16/2021 she was discharged from the hospital with Discharge Diagnoses: //Bilateral subarachnoid hemorrhage //Intractable headache //Essential hypertension, uncontrolled//Generalized anxiety disorder. Thursday 03/04/2021 we follow up with the neurologist. Saturday 03/06/2021 she went to the ER with blood preasure of 189/83.
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| 65 | 2021-03-08 | abdominal pain upper | Migraine headache, chills, fever, body ache, stomach ache |
| 65 | 2021-03-08 | decreased appetite |
Fever of 3 degrees, muscle aches and pains, chills, some loss of hearing, brain processing slowness,...
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Fever of 3 degrees, muscle aches and pains, chills, some loss of hearing, brain processing slowness, headache, loss of appetite, dizziness.rash and itchiness of arm.
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| 65 | 2021-03-08 | difficulty swallowing |
difficulty swallowing, tongue swelling was administered epi-pen .30 mg IM, VSS, 911 called and tran...
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difficulty swallowing, tongue swelling was administered epi-pen .30 mg IM, VSS, 911 called and transported to ER
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| 65 | 2021-03-08 | nausea |
Strange feeling in head. Felt like wave rushing then sudden intense feeling to have bowel movement. ...
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Strange feeling in head. Felt like wave rushing then sudden intense feeling to have bowel movement. Started to black out and went down but not unconscious. Then bowel movement and nausea at same time and started dripping sweat profusely. Soaked my clothes. So weak could not get up or felt as though will pass out. Then got the chills and loud ringing in my ears. Whole episode lasted about 20-30 minutes then went to bed at 7:30 p.m. felt so exhausted and fatigued. Woke up about 4a.m. arm hurt but felt okay. Little off balance, fatigued, weak all day. Next day arm sore but improving. Now fine. Saw doctor today, he advised me to report and wait to see advice from Pfizer as to get2d dose or not.
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| 65 | 2021-03-08 | nausea |
approximately 1 1/2 hours after vaccination, I developed transient nausea, followed by a strange sen...
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approximately 1 1/2 hours after vaccination, I developed transient nausea, followed by a strange sensation in my head, fullness in the ears, ringing associated with nausea, the following day it was worse, upon waking and walking my legs felt rubbery which spontaneously resolved after briefly walking, the nausea, supratentorial symptoms, fullness in the ears persisted, no vomiting, today is the 4th day post injection without improvement. Injection site pain lasted 2 days-not bothersome. Consider my symptoms moderate and interfering with daily activities.
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| 65 | 2021-03-09 | nausea, diarrhea, vomiting |
That night I didn't feel well, I went to bed early. Chills in mddle of night. I didn't go to work (w...
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That night I didn't feel well, I went to bed early. Chills in mddle of night. I didn't go to work (wasn't planning on it) and I didn't get up and I realized I couldn't get out of bed. I somehow got up and put leggings on and I couldn't stand up and I unlocked the door because a repair man was going to be coming to fix the dishwasher. I fell asleep after he left - he had to bring me my checkbook - never took my prednisone for the day - I had chills and fever all day. I had fever - 104. I had nausea, body aches, vomiting, diarrhea and my husband gave me 20 mg of steroids when he got home and two of my Florinef and two ice chips to swallow. He carried me upstairs - I was not cognizant of what was going on. I wasn't cognizant the whole day of Wednesday. He gave me soup later and more doses of steroids. I didn't have a fever - or else it was down to 100. I still had diarrhea, nausea, headaches, body aches and I only ate the BRAT diet. I couldn't go to the office Thursday or Friday. On Friday, I still had a horrible headache. I was still doubling up on my steroids that day as I still felt so horrible. That Friday night, I finally felt wonderful. But I had taken a lot steroid after all that.
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| 65 | 2021-03-09 | nausea, vomiting |
Patient developed severe nausea, vomiting on day of vaccination and subsequently developed bloody d...
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Patient developed severe nausea, vomiting on day of vaccination and subsequently developed bloody diarrhea. Diagnosed with non-specific colitis. Awaiting colonoscopy,
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| 65 | 2021-03-10 | nausea, vomiting |
Dizziness in the morning that wore off, followed by late night nausea, vomiting lasting 2 hours. Na...
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Dizziness in the morning that wore off, followed by late night nausea, vomiting lasting 2 hours. Nausea still present but improving.
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| 65 | 2021-03-10 | nausea |
I was slightly dizzy about 5 minutes after but then was fine. 10 days later I was fatigued, dizzy, n...
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I was slightly dizzy about 5 minutes after but then was fine. 10 days later I was fatigued, dizzy, nauseous and had the chills. Body ache and fatigue only lasted a few days but the dizzy and nausea remained on and off for next few weeks. Today it has been 38 days later and the dizzy has subsided over past week but I continue to experience nausea on and off and this is very worrisome. Due to this I have not had the second shot because I feel unwell. I saw my primary doctor and did not find anything wrong. I also have not heard of anyone who has had this same experience so I am scared to have the other shot even though I know I need it. I just need some answers. Thanks for responding.
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| 65 | 2021-03-10 | nausea | Chills, sweats, massive headache, body aches, nausea |
| 65 | 2021-03-10 | vomiting | chills, fever, vomiting, muscle spasms, extreme fatigue, for three days; fatigue lasting 7 days |
| 65 | 2021-03-11 | difficulty swallowing |
About 10 minutes after the shot I felt a warm sensation inside my arm running all the way down to my...
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About 10 minutes after the shot I felt a warm sensation inside my arm running all the way down to my arm and my hand went numb . I waited a few more minutes then I was released. Then 1/2 hour later my eyes were very sensitive to light I wore sunglasses. Then five hours after the shot I had chest discomfort on left side of my chest which felt like I was having a heart attack pain subsided then every 2 hours it came and went until the middle of the night. Then next day still having same chest pain. Then I had difficulty swallowing was choking so I called my doctor. I also had trouble breathing. Dr. Advised to go to ER if I needed to. I rested and rested and monitored myself. Blood pressure fluctuated somewhat. Still had chest pain and discomfort 24 hours after the vaccine. I had never had chest pain or discomfort before. It was quite alarming. Not being able to swallow was alarming also. Several years ago I had an allergic reaction to a cleaning problem some of the same symptoms it was very scary no heart or chest pain with that allergic reaction to a cleaning product that had bleach in the product.
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| 65 | 2021-03-11 | nausea, vomiting |
Extreme migraine. Head pain, neck pain, nausea, vomiting,, dizziness, overall weakness, light sensit...
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Extreme migraine. Head pain, neck pain, nausea, vomiting,, dizziness, overall weakness, light sensitivity. I have migraine disease but since I began Aimovig injections nearly a year ago I have very few migraines, Those I have had have been extremely mild, just headache usually relieved by otc meds. Additionally I have not had nausea and vomiting with any migraine episode for many years. When I woke at yesterday morning, I was in extreme pain across the right side and back of my head and down to my neck and shoulders. 9 out 10. I took my prescription, Eletriptan .5 mg at 5:45 and went back to bed. It gave little relief of symptoms. I was unable to sleep and at about 7 a.m. I was hit with waves of nausea and extreme violent vomiting. This last for several minutes. At approximately 9 a.m. I took a 2nd dose of Eletriptan and slept a little. Again at about 11: a.m. I was hit with another round of extreme nausea and vomiting which lasted about 5-6 minutes. I slept a bit and around 3 p.m. was finally able to drink a little water. Still very weak but pain had subsided significantly, down to about a 4 / 10. By 6 pm. I was almost pain free ? symptom free though very weak still. Ate a little at about 7 p.m. I know this was a migraine which I am diagnosed with but it was extreme even for me, and especially in recent years. It was very unusual in timing and severity and I felt it needed reporting.
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| 65 | 2021-03-12 | abdominal discomfort, nausea |
1 hour after receiving vaccine became dizzy. It passed within an hour. Following day had severe lowe...
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1 hour after receiving vaccine became dizzy. It passed within an hour. Following day had severe lower burning back pain.. it resolved following day. The next day Feb 11, was severely nauseated all day. Feb 12 nausea resolved. Feb 18 nausea returned. Stomach upset for over 2 weeks then began to resolve. Called Dr . He rec delay 2nd vaccine 1-2 weeks.. Saw Dr on March 8 to discuss 2nd vaccine. Had 2nd vaccine March 11. Same symptoms again but much milder. Also had fatigue for weeks after 1st vaccine and again after 2nd vaccine. .
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| 65 | 2021-03-12 | nausea |
March 12, 2021 @ 12:01 am. Developed Severe headache, nausea, body aches. Headache worsened when lay...
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March 12, 2021 @ 12:01 am. Developed Severe headache, nausea, body aches. Headache worsened when laying down. Self treated with over the counter Dimenhydrinate 3 times. For nausea. Tylenol 1. Headache did not go away after 4 hours. Took a Butalb/asa/caff/codeine 30mg at 4am. (PRN order for migraines) Headache eased up a lot. Felt flushed through the night. March 12, 2021- About mid afternoon on started a painful swelling under left armpit. (Injection was in left arm). Treated with Ice packs. March 13, 2021- swelling under left armpit worsening. Cannot put my arm down. Treating with ice packs. Nausea, headache are better. Body aches are reduced.
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| 65 | 2021-03-13 | diarrhea |
Slight headache right after. I took Tylenol. After 12 hrs, rash on chest, stomach and legs. I too...
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Slight headache right after. I took Tylenol. After 12 hrs, rash on chest, stomach and legs. I took Benadryl. 2nd Day, Next morning: headaches. Tylenol. Foggy and not clear headed. L arm hot and hurts, Hip, knee and ankle on L side painful. Very tired. Rash is gone. Mid day: anxiety and feeling down. Called Dr. and got nurse and then called therapist. headache still continues. I took a nap, I never take naps unless very sick. Eve: Rash came back. Benedryl Headache. Tylenol 3rd day: Diarrhea. headache, still foggy and tired.
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| 65 | 2021-03-13 | nausea |
The minute I stood up after vaccine, I was very dizzy and my heart started pounding. Then I got naus...
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The minute I stood up after vaccine, I was very dizzy and my heart started pounding. Then I got nausea. Was sent to Urgent Care office where I got EKG, which showed no problems with my heart. Went home, weak. Woke at 2:00 am with night sweats. When I got up I noticed swelling on face, throat, hands & feet. Faint pink rash ran up both fore arms and I had welts rising on my wrists. Nurse line I called said to to to ER asap, Took me a few hours to find a ride, my throat was closing up more by that point. I could tell over a few hours that my throat was swelling up. Went to nearest ER where I was very mentally confused. They gave me a shot of steroids and Benedryl. Later that night I got chills and was VERY weak. Had night sweats again. After a few days of rest, am still weak.
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| 65 | 2021-03-13 | nausea |
Some arm soreness and dizziness 12 hours after vaccine. Awoke with chills 18 hours after vaccine. Fl...
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Some arm soreness and dizziness 12 hours after vaccine. Awoke with chills 18 hours after vaccine. Flu-like symptoms from that time for another 12 hours or so: body aches, tiredness, nausea.
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| 65 | 2021-03-14 | diarrhea, nausea |
Full anaphylaxis, Vertigo, Blood Pressure spike to 200 and it lingered there. Sent immediately to ...
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Full anaphylaxis, Vertigo, Blood Pressure spike to 200 and it lingered there. Sent immediately to Hospital. Was administered IV Benadryl and Prednisone. Slept for three hours. BP dropped to 165 and was released with Benadryl and Prednisone to take for the next four days. Next several days of nausea, diarrhea, fever, weakness, shakes. No energy. Not feeling well until March 14th.
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| 65 | 2021-03-14 | difficulty swallowing |
9:40 am - Husband states patient has lip swelling and itching. 9:45 am - Patient states mouth and th...
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9:40 am - Husband states patient has lip swelling and itching. 9:45 am - Patient states mouth and throat itching, lips swelling. Given sip of water - difficulty swallowing but denies difficulty breathing. Patient states she is allergic to multiple meds. 9:55 am - Itching in multiple places and repeatedly clearing throat with difficulty swallowing. Lip swelling noted - patient now moved to a bed and 911 is called. 10:00 am - Fire medics arrive and patient assessed. Patient taken to hospital via ambulance.
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| 65 | 2021-03-15 | decreased appetite, abdominal discomfort |
Prior to vaccine took 2 acetominophen. Upon injection had sensation of an angry bee sting that subs...
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Prior to vaccine took 2 acetominophen. Upon injection had sensation of an angry bee sting that subsided in a few minutes. Left shoulder, neck & arm very sore, iced injection site within 1 hour of receiving. Early evening, didn't feel well-- upset stomach, loss of appetite, head ache, lethargic. Ended up sleeping abnormal amount over next 3 days with aches in joints, specifically in hands & knees.
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| 65 | 2021-03-15 | nausea, abdominal pain upper |
COVID-19; COVID-19; Fatigue; general achiness; respiratory symptoms; loss of taster intermittent los...
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COVID-19; COVID-19; Fatigue; general achiness; respiratory symptoms; loss of taster intermittent loss of smell; loss of taster intermittent loss of smell; coughing; congestion; sore throat; headache; Exposure to SARS-CoV-2; Nausea; injection site pain; lightheadedness; Stomach pain; extreme exhaustion; This is a spontaneous report received by Pfizer from Agency, (Mfr. Control No: 2020US004529) through a contactable physician. A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 29Dec2020 (at the age of 65-year-old) as a single dose for Covid-19 immunisation and also started to receive abaloparatide (TYMLOS, Formulation: injection, Lot number: RT01102, Expiration date: Dec2022) via subcutaneous from 20Dec2020 to an unknown date, at 80 ug, once a day for osteoporosis. The patient medical history, included autoimmune disease-Behcet's disease causing ulcers, osteoporosis and constipation, and all were ongoing. The patient concomitant medication was not reported. On 29Dec2020, the patient experienced injection site pain, fatigue, nausea, Stomach pain and Light headness and the patient believed these symptoms were due to the vaccine. On 04Jan2021, the patient was Exposure to SARS-CoV-2. It was also reported that on 16Jan2021, the patient experienced coughing, fatigue, lost taste/smell, congestion, sore throat, headache, respiratory symptoms, general achiness and also had COVID-19 on an unknown date. It was reported that general achiness and respiratory symptoms possibly related to Covid-19 which resulted in emergency room visit on 16Jan2021. The cough was treated with benzonatate pearls. The following relevant laboratory tests were performed: Rapid COVID-19 (12Jan2021), negative, COVID 19 PCR test (15Jan2021), negative, and chest x-ray (16Jan2021), clear, negative. The action taken in response to the events for abaloparatide was unknown. The outcome of the events COVID-19, light headedness, stomach pain, exposure to sars-cov-2 was unknown, for the events nausea, general achiness, respiratory symptoms, loss of taster intermittent loss of smell, coughing, congestion, sore throat, fatigue, headache was not recovered and for the events injection site pain, extreme exhaustion was recovered on 31Dec2020. Information on batch/lot number was requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 29Dec2020, and contracted COVID on an unspecified date. No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection. Further information like COVID infection date needed for a full meaningful medical assessment.
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| 65 | 2021-03-15 | nausea, vomiting |
Patient felt like going to pass out and she did then, she was probably out less than in a minute; Se...
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Patient felt like going to pass out and she did then, she was probably out less than in a minute; Severe headache; Nauseous; Throwing up/Vomiting; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient (weight: 81.65 kg, height 170 cm) received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN6201) at single dose, on 22Feb2021, for COVID-19 immunisation. Relevant medical history included thyroid disorder form an unspecified date. Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid disorder. On 22Feb2021, the patient experienced sore arm. On 25Feb2021, the patient developed severe headache, nauseous, and vomiting (throwing up) and the patient felt like going to pass out and she did then, she was probably out less than in a minute. The patient described as following: so, on 25Feb2021, the headache increased throughout the day and her nauseousness continued throughout the day and in the afternoon with the pain of the headache she thought she passed out, she vomited that gave her little bit of relief but then she took "two (not clarified) Advil and went to bed". Clinical outcome of the adverse events was unknown at time of this report. Patient asked if should be expected the same kind of reaction when she got her second shot.
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| 65 | 2021-03-16 | abdominal pain upper |
1st day after-fatique/headache/weakness/chills 2nd day- better 3rd day- dizziness started late nigh...
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1st day after-fatique/headache/weakness/chills 2nd day- better 3rd day- dizziness started late night, subsided next morning. 4th day- same as 3rd 5th day- extreme dizziness at night, continued next day with sick feeling, stomach pain, leg weakness. Heart palpitations and racing(during night) Symptoms continued following 6th-10th days. Went to hospital emergency room 11th day due to doctor concerns of possible aFib. Admitted in Observation Unit overnight with IV fluids & heart monitor. Heart attack ruled out. Tachycardia event with follow up at cardiologist.
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| 65 | 2021-03-16 | nausea |
Vertigo, nausea, migraine headache, weakness, 4 days of hearing/feeling blood pressure/pounding in 1...
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Vertigo, nausea, migraine headache, weakness, 4 days of hearing/feeling blood pressure/pounding in 1 ear, but no fever or redness or pain in ears. No other infections or symptoms thereof. ER visit with blood and urine tests and an MRI revealed nothing definitive. Response to symptom-alleviating shots was less than desirable, hence the MRI. Sent home with anti-vertigo and anti-nausea prescriptions and referral to an ENT specialist (appt set for Mar 21). Patient unable to do anything but lie down. Efficacy of prescriptions is pending. Symptoms are projected to gradually subside and eventually disappear.
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| 65 | 2021-03-16 | nausea |
Pt was in COVID-19 Observation area pt complained of Headache , shakyness, and Nausea. B/P @ 128/53 ...
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Pt was in COVID-19 Observation area pt complained of Headache , shakyness, and Nausea. B/P @ 128/53 P-82. Doctor available in Observation area to evaluate pt and pt taken to Clinic via W/C by R.N..
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| 65 | 2021-03-16 | vomiting, abdominal pain, nausea | Headache, then subsequent nausea, vomiting, and abdominal pain several hours after vaccine |
| 65 | 2021-03-16 | vomiting |
Severe vomiting within 45 minutes of receiving vaccine. I had 4 distinct vomiting episodes, vomitin...
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Severe vomiting within 45 minutes of receiving vaccine. I had 4 distinct vomiting episodes, vomiting 3 or 4 times during each episode. I took a single dose of Zofran at about 2 pm and had last vomiting episode around 4 pm. Vomiting episodes lasted a total of about 6 hours. I had chills for about an hour right after 1st vomiting episode. I had significant left arm pain that prevented use of arm for 2 days. I also had extreme weakness the 1st day, I couldn?t get out of bed except to vomit. I got the vaccine on Wednesday and didn?t feel fully recovered until Sunday.
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| 65 | 2021-03-17 | abdominal discomfort, nausea |
The morning after the shot I began to feel achy in joints, headache, upset stomach and slight nause...
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The morning after the shot I began to feel achy in joints, headache, upset stomach and slight nausea, my arm hurt at the site, Temp 98.9 temporal. I took Ibuprofen, worked and 6 hours later felt the same so repeated Ibuprofen and then it was over with. No further untoward problems. The injection site still hurt 2 days and was bruised 3 days.
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| 65 | 2021-03-17 | nausea |
general malaise and sore arm on March 16th. Wednesday felt better but not perfect. March 18th got ...
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general malaise and sore arm on March 16th. Wednesday felt better but not perfect. March 18th got up with headache, nausea and dizziness.
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| 65 | 2021-03-17 | nausea |
Fever 100.7; chills; headache; nausea; injection site pain redness & swelling; injection site pain r...
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Fever 100.7; chills; headache; nausea; injection site pain redness & swelling; injection site pain redness & swelling; injection site pain redness & swelling; exhaustion; This is a spontaneous report from a contactable 65 reporting for herself. A 65-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN6201/expiration date: not provided), via an unspecified route of administration, on 12Feb2021 at 11:00 (at the age of 65 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included Hashimoto's hypothyroidism. The patient has allergies to halibut and sea kelp. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL8982/expiration date: not provided), via an unspecified route of administration, on 22Jan2021 at 03:30 PM (at the age of 65 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included levothyroxine sodium (SYNTHROID), rosuvistatin, acetylsalicylic acid (ASPIRIN), probiotic, and vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Feb2021 at 23:00, the patient experienced fever 100.7, chills, headache, nausea, injection site pain redness and swelling, and exhaustion. The events did not require hospitalization. The outcome of the events fever 100.7, chills, headache, nausea, injection site pain redness and swelling, and exhaustion was recovering. Since the vaccination, the patient had not been tested for COVID-19.
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| 65 | 2021-03-17 | nausea |
Asymptomatic other than short-lived nausea lasting 1 hour; Abnormally elevated LFTs done 48 hours af...
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Asymptomatic other than short-lived nausea lasting 1 hour; Abnormally elevated LFTs done 48 hours after vaccination
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| 65 | 2021-03-17 | vomiting, nausea |
Began as H/A and some overall achiness, nausea, moved quickly to severe chilling for several hrs, di...
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Began as H/A and some overall achiness, nausea, moved quickly to severe chilling for several hrs, did hv small episode of vomiting. Took Tylenol ES 2 caps+ 1 generic maximum strength acid reducer ice chips, comforter blankets and heating pad. By Midnite, chilling, n/v subsided. Just remained for the nite w/multiple blankets. Woke up in am w/o issue
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| 65 | 2021-03-18 | abdominal pain upper, gastrointestinal disorder, abdominal pain, diarrhea |
Severe abdominal cramps and diarrhea for 2 days and then mild stomach pain and intestinal issues sin...
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Severe abdominal cramps and diarrhea for 2 days and then mild stomach pain and intestinal issues since then and continuing through today. It?s been 1 week and 3 days.
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| 65 | 2021-03-18 | flatulence, decreased appetite, diarrhea | Fever, headache, chills, joint pain, gas, diareah, loss of appetite, anger |
| 65 | 2021-03-18 | nausea |
Blurry vision, difficulty with memory, nausea, brain fog, weakness right hand, weakness both legs...
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Blurry vision, difficulty with memory, nausea, brain fog, weakness right hand, weakness both legs, pis and needles sensation toes, slight headache, sore arm
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| 65 | 2021-03-18 | nausea |
Mild soreness below injection site the day of injection. Fever started day after injection lasting 5...
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Mild soreness below injection site the day of injection. Fever started day after injection lasting 5 days, above 100 everyday, 101 to 102.2 on the 4th and 5th days, then back to normal (97.8). Chills and shaking on 3rd and 4th days. Mild nausea and dizziness. Stayed in bed 2nd to 4th day with fatigue. Coughing mostly when temperature was high. Still some coughing now after 10 days. Severe allergic reaction with rash starting at groin area the day after injection, moving up sides to underarms the 3rd day, then hands and feet the 4th day. Dermatologist recommended not getting 2nd shot.
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| 65 | 2021-03-18 | nausea | TERRIBLE HEADACHE, NAUSEA, BODY ACHES, SINUS CONGESTION |
| 65 | 2021-03-18 | nausea | Headache, fever, chills, nausea, body aches and pains, tiredness. |
| 65 | 2021-03-18 | nausea | Dizziness, nausea, blurred vision, elevated blood pressure, tightness in neck muscles |
| 65 | 2021-03-18 | vomiting, nausea, retching |
Seizures; throat swelled up; Troponin level increased; Mild heart attack; arm was hurting; breathing...
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Seizures; throat swelled up; Troponin level increased; Mild heart attack; arm was hurting; breathing issues; Dry heaves; Mucus to come out; Nauseous; Dizzy; Headache; Ears became hypersensitive; Senses heightened; Throwed up; This is a spontaneous report from a contactable other health professional (patient). A 65-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on 27Feb2021 (lot# EN6205), as 0.3 ml single, for COVID-19 immunisation. Medical history included seizure from 2017 (she hasn't had a seizure in 8 months), allergy (to a lot of things). Concomitant medications were not reported. The patient did not have other vaccinations in 4 weeks prior. Within 15 minutes from having the vaccination at the center the patient experienced the first seizure that lasted about an hour. The seizure was really bad, she had breathing issues, dry heaving like she was trying to throw up, mucus to come out. The paramedics checked her out, they stayed around until she came out of the seizure. The patient went home and then at 07:50 PM she started heavy shallow breathing, was nauseous, dizzy, had a headache, which also happened at the center. Ears became hypersensitive, it was so noisy like loud, but her husband and the paramedics said it wasn't loud but she could hear it, all of her senses were heightened. She had a second seizure and didn't known how long it lasted. Patient had another seizure at 08:25 PM, at 08:40 PM she had another one, at 09:00 PM patient was coming back around and had another seizure and her throat closed up and that's when she went to the hospital, when her throat started to close up. While the patient was in the emergency room (ER) she had another seizure, she had 6 total seizures, she has never had this many before so she knows it was an adverse event to this vaccination. The seizures also increased the patient's heart enzymes- troponin levels. The patient has an EEG, was given 4 baby chewable Aspirin, as she had a mild heart attack. She thought the seizure increased her troponin. The patient mentioned that during the first event at the center, she was so into the seizures, she remembers grabbing her left shoulder, her arm was hurting. She was so into the seizure and trying to throwing up that it didn't dawn on her. The hospital didn't tell her she had a mild heart attack, it just dawned on her because her troponin levels were up mildly and she thought the seizures were triggering something in her heart, not just her seizures. The patient got another headache and was dizzy and had shallowing breathing. Seizures recovered on 28Feb2021. The patient underwent lab tests and procedures which included chest x-ray: normal, it didn't show pneumonia or fluid on the lungs on 27Feb2021, electrocardiogram (EKG): normal on unspecified date, electroencephalogram (EEG): normal on 27Feb2021, troponin: increased on 27Feb2021. Follow-up attempts are completed. No further information is expected.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 65 | 2021-03-20 | diarrhea |
4 bouts of diarrhea from 4:00pm to 8:00pm, occurring on the second day after vaccination. No medica...
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4 bouts of diarrhea from 4:00pm to 8:00pm, occurring on the second day after vaccination. No medical treatment needed. Hydrated with smart water (electrolytes) and slept 10 hours that night, with no further diarrhea in the night. Ate light for the rest of Thursday and all day Friday.
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| 65 | 2021-03-20 | nausea |
March11,12,13 injection site pain /March14 -21 tiredness,severe headache,muscle pain chills, joint p...
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March11,12,13 injection site pain /March14 -21 tiredness,severe headache,muscle pain chills, joint pain, fever,nausea, feeling unwell
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| 65 | 2021-03-20 | nausea |
After Dose 1, that night, sore arm, pressure headache in top of head, fatigue. Everything improved w...
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After Dose 1, that night, sore arm, pressure headache in top of head, fatigue. Everything improved with exception of lingering headache for about 2 weeks. Evening after Dose 2, sore arm, worse headache, next day burning eyes, felt like flu. After 48 hours all improved but headache lingered in top of head pressure and nausea. On 3/3/21 8:15 am full blown sharp pain left side of head and then vise grip type headache like top of head was going to explode, severe shaking uncontrollable jerking, stuttering, worst headache ever, high BP over 200/170. Went to ER. CTA head wi 3D reconstruction, labs, etc. gave Toradol, Ativan Zofran Compazine and Fluids, Released after several hours, unspecified headache. Slept for 11 hours, next day severe brain fog and fatigue. On 3/6/21 awoke with same dull headache, but seemingly more jitteriness, by 10:40, another full blown extremely painful headache pins/needles from head to toe. Ambulance arrived BP 208/160ish. Transport to hospital. Ran many tests CT, etc. Gave Morphine, sent home after 5 hours. Saw Neurologist 3/17
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| 65 | 2021-03-20 | vomiting |
About 12 hours after my 2nd dose of Pfizer vaccine I had extreme chills, fever of 102 degrees, vomit...
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About 12 hours after my 2nd dose of Pfizer vaccine I had extreme chills, fever of 102 degrees, vomiting, and severe headache. Most lasted about 36 hours and all gradually went away. Severe headache was the last symptom to go away but receded about 6 hours after other symptoms . About a week after 2nd dose my injection site became very sore for 3 days. Had not been very sore prior.
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| 65 | 2021-03-21 | diarrhea | Persistent loose stools since the vaccine |
| 65 | 2021-03-21 | nausea |
delirium; Bone freezing chills; left arm, shoulder and neck intense pain; left arm, shoulder and nec...
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delirium; Bone freezing chills; left arm, shoulder and neck intense pain; left arm, shoulder and neck intense pain; left arm, shoulder and neck intense pain/soreness in neck; debilitating headache; pounding heart; feeling like body will explode from inside out; unable to get up; nausea; soreness in neck and armpits; This is a spontaneous report from a contactable consumer (patient herself). A 65-year-old female patient, not pregnant, received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm, on 03Mar2021 09:15, at a single dose, for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took codeine and experienced allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) administered on the left arm on 10Feb2021 09:15 for covid-19 immunization at the age of 65-years-old. The patient did not receive other vaccines in four weeks and did not have other medications in two weeks. The patient did not have covid prior vaccination. The patient experienced the following adverse events on 03Mar2021 at 18:00 - bone freezing chills; delirium; left arm, shoulder and neck intense pain; debilitating headache; pounding heart; feeling like body will explode from inside out; unable to get up; nausea; continued soreness in neck and armpits and; headache for 3 days. The patient recovered from headache on 06Mar2021 18:00. The patient recovered from all the other remaining adverse events on Mar2021. The patient took ibuprofen as treatment for all the reported adverse events. The patient was not covid-tested post-vaccination. No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.
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| 65 | 2021-03-21 | vomiting, decreased appetite, nausea |
Presented to ED on 3/14/21 with shortness of breath. She started feeling sick march 6th, with fatigu...
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Presented to ED on 3/14/21 with shortness of breath. She started feeling sick march 6th, with fatigue and no appetite. She developed a cough, loss of taste/smell, and then nausea/vomiting. She tested positive for Covid-19 on the 11th. She hasn't been able to hold down meds for the last week. She is having intermittent chest pains which she attributes to not being able to take her cardiac meds. Was started on supplemental oxygen and admitted to hospital. Is still admitted at time of writing.
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| 65 | 2021-03-21 | vomiting, nausea |
experienced body aches, skin sensation to touch, nasal drainage, injection site tenderness, eyes wat...
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experienced body aches, skin sensation to touch, nasal drainage, injection site tenderness, eyes watering, headache, vomiting x6 over period of 10 hrs. Spent all day March 18 in bed due to vomiting , and above symptons. Continued with low grade nausea and HA on March 19. Felt fine on March 20. Treated self with Tylenol and restarted routine meds March 19 PM. Unable to take any meds on March 18 due to vomiting. Did not require seeing healthcare.
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| 65 | 2021-03-21 | vomiting | fever (spiking at 101.7), vomiting, body ache, heart racing and blood pressure raised |
| 65 | 2021-03-22 | nausea, vomiting |
Started 10 min post vaccine, began to feel chills, nauseous with body aches. Next day, symptoms wors...
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Started 10 min post vaccine, began to feel chills, nauseous with body aches. Next day, symptoms worse with vomiting. PCP prescribed zofran to use as needed. Denies fever. Symptoms resolved as of 3/21/2021, except for nausea. Follow up with PCP as needed.
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| 65 | 2021-03-22 | vomiting, diarrhea | Roaring headache, vomiting and diarrhea. Duration 2 hours. |
| 65 | 2021-03-22 | vomiting, nausea |
Patient received dose 1 of COVID vaccine on 1/4/2021. On 1/18/2021 developed body aches, nasal cong...
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Patient received dose 1 of COVID vaccine on 1/4/2021. On 1/18/2021 developed body aches, nasal congestion, and nasuea/vomiting. Tested positive for COVID.
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| 65 | 2021-03-23 | nausea, decreased appetite |
Couldn't eat, very sore over whole body, needed to sleep most of days, very weak, nauseous, headache...
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Couldn't eat, very sore over whole body, needed to sleep most of days, very weak, nauseous, headaches, felt at times I might have been having a heart attack, very hard to breathe deep & felt like chest constricting. Lasted for a full 5 days.
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| 65 | 2021-03-23 | nausea, vomiting |
Friday @ 1am started throwing up and could not stop for 7 hrs. Very Nauseous through Sat and part o...
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Friday @ 1am started throwing up and could not stop for 7 hrs. Very Nauseous through Sat and part of Sunday . Had hot and cold chills through Sunday. Legs and arms were feeling fatigue. Started eating again by Monday afternoon. Tues just arms and legs feeling like wet noodles. Today Wednesday feeling 50% better then day before.
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| 65 | 2021-03-23 | nausea |
Felt outside of my body, hazy, not myself, now I am nausous, sweaty, for the last two days (3/21 - ...
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Felt outside of my body, hazy, not myself, now I am nausous, sweaty, for the last two days (3/21 - 3/22) Just feel yucky. Have not gone to work.
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| 65 | 2021-03-24 | abdominal pain upper, diarrhea |
Soreness at injection site A few days after 2nd dose stomach cramps with diarrhea. Two weeks after ...
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Soreness at injection site A few days after 2nd dose stomach cramps with diarrhea. Two weeks after still having stomach pain and diarrhea
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| 65 | 2021-03-24 | nausea, decreased appetite, vomiting |
Started about 3am Saturday Morning March 6 with extreme pain between shoulder blades. Took 2 Advil a...
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Started about 3am Saturday Morning March 6 with extreme pain between shoulder blades. Took 2 Advil and was able to go back to sleep. Woke in the morning feeling fine. Then started becoming ill early afternoon. Fever every day for 2 weeks. Nausea, vomiting, lose of appetite, extreme fatigue, headache, light sensitivity, rash, nagging slight cough and some nasal stuffiness mostly when talking (this might be because of the pollen) We were told it was an unidentified virus that would have to "run its course". Even though we are vaccinated, we continue to quarantine because we provide child care for my grandson. There was virtually no circumstance where I would have been exposed to a virus. Also, my husband had to care for me because I could do almost nothing for myself and he did not contract the virus.
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| 65 | 2021-03-24 | stomatitis |
I tested positive for Covid in early December, 2020. 5 days after I received the vaccine, I woke up...
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I tested positive for Covid in early December, 2020. 5 days after I received the vaccine, I woke up to extreme dizziness with the room just spinning. My blood pressure increased to around 212/101 for much of the day. Normal is around 120/70. The dizziness finally subsided later in the day and the blood pressure went down to about 168/85 by evening. Then I minor developed a headache. I also developed sores in my mouth and on my tongue. I still have those today (the day after).
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| 65 | 2021-03-24 | vomiting, nausea | Vomiting, nausea, headache, muscle aches and muscle weakness, chills for several days after vaccine |
| 65 | 2021-03-25 | nausea |
103.9 fever, excruciating headache, lymph nodes under both arms swollen and hurt, fatigue, hurt all ...
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103.9 fever, excruciating headache, lymph nodes under both arms swollen and hurt, fatigue, hurt all over my body, nausea, injection site sore
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| 65 | 2021-03-28 | abdominal discomfort, diarrhea, nausea |
Dehydration, hospitalized/dehydrated; My fever broke on Monday; Cruel, incapacitating headache/have ...
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Dehydration, hospitalized/dehydrated; My fever broke on Monday; Cruel, incapacitating headache/have such a painful headache that I can't eat; Eye pain; Aversion to food/ can't eat; Constant watery diarrhea despite not much food/diarrhea I have so bad; Constant nausea; Utter and complete lassitude/ exhausted; Being in bed, low energy; Stomach upset; Cough; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female consumer patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in the left arm on 04Mar2021 16:00 as a single dose for COVID-19 immunisation. Medical history included, in the 1990's, was diagnosed with systemic sclerosis (limited, used to be called CREST scleroderma), pretty severe Raynaud's syndrome, telangiectases, fatigue and sometimes joint aches. Patient was healthy despite this. Patient was not pregnant. The patient was not diagnosed with COVID prior vaccination. Concomitant medications in two weeks included amlodipine besylate, escitalopram oxalate (LEXAPRO), and clonazepam (KLONOPIN). The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 11Feb2021 04:00 PM and felt unwell but went to work and was fine in 2 days. On 04Mar2021, it was very different, the patient began having symptoms within 4 hours after receiving vaccine at 9 o clock that night. The patient stated "symptoms worsened and it is one week today and I am still sick. My fever broke on Monday. I still have cruel, incapacitating headache, eye pain, aversion to food (extremely weird for me), constant watery diarrhea despite not much food, constant nausea, utter and complete lassitude, dehydration (hospitalized, 2 liters of fluids), pain meds and anti-nausea meds. I have missed a week of work and this is a serious issue for many. I am OK but using precious sick time." Events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Patient stated "I missed whole week to work and I'm still sick. I have had so many different symptoms and some have gone away like my fever is gone but I have such a painful headache that I can't eat, nausea and constant diarrhea, you get the idea. I'm not against the vaccine but I think it would be good if people like me, people that have had my experience know, I hope it's within the normal range, I still don't know I would love to talk to somebody and find out if what I am experiencing is in the normal range, but it's not, people saying they experience so far the kind of the level of being in bed, low energy, unable to eat, fever, headache, stomach upset, I didn't have a cold, I had respiratory, I had a cough that has cleared up. I was hospitalized yesterday with fluids to become hydrated. It's important for us, you know, I mean, I leave the work that not good, people need to be prepared, it should be sick time I think it's important there is a follow up, absolutely. I was very happy I got the vaccine but I am so sick and it's been a week today so, that's why I decided to call and I was in the hospital yesterday, getting fluids dehydrated and I was admitted (reason for hospitalization was not clarified). I wasn't admitted, I was in the hospital for the day on IV fluids, anti-nausea medication, pain medication also, 3 things they gave me in an IV. They sent me home but the diarrhea I have so bad, I'm exhausted, but I have to spent all my time in the toilet, I thought today might be, I might wake up it would be healing today but I'm still pretty sick." Outcome of fever and cough was recovered, and of remaining events was not recovered. The patient underwent COVID-19 virus test via nasal swab on 03Mar2021 with negative result. Information about lot/batch number has been requested.
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| 65 | 2021-03-28 | diarrhea, nausea |
received 1st dose 1/15/21, complaints of cough, nausea, diarrhea started 1/20/2021. Presented to th...
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received 1st dose 1/15/21, complaints of cough, nausea, diarrhea started 1/20/2021. Presented to the ED on 1/24/2021 with the same symptoms; COVID-19 test came back +. Per ED physician, "On repeat evaluation she is resting comfortably in the room. O2 saturation remains in the low 90s on room air. Vital signs otherwise stable. Her Abbott Covid test was positive. CBC does show leukopenia otherwise unremarkable. BMP shows mildly elevated creatinine, no other significant abnormalities. Chest x-ray unremarkable. Patient was ambulated with pulse oximeter and O2 saturation dropped into the mid 80s. Recommended she be admitted and she agrees. Case discussed with hospitalist who agrees to meet the patient. We will give her Decadron here". Admitted to the RCU where she received ceftriaxone and azithromycin for bacterial pneumonia. Transferred to healthcare facility on 2/1/2021.
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| 65 | 2021-03-28 | diarrhea | shortness of breath/diarrhea |
| 65 | 2021-03-28 | nausea, diarrhea |
then everything went black &collapse but not unconscious; felt slightly dizzy; sudden strange feelin...
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then everything went black &collapse but not unconscious; felt slightly dizzy; sudden strange feeling in head like wave washing over; Then intense feeling of sudden diarrhea; nausea; profuse sweating soaks clothes; weak all over; shaking with chills; shaking with chills; can't get up or will black out again; ringing in ears; Exhausted/fatigued; arm hurt; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6198, expiry date not reported), via an unspecified route of administration, administered in right arm on 04Mar2021 13:15 at a single dose for COVID-19 immunization. Medical history included migraine with aura, vertigo vestibular nueronitis, osteoporosis, TIA (transient ischaemic attack), B12 deficiency, IBS (irritable bowel syndrome), all from an unknown date and unknown if ongoing. The patient was not pregnant at the time of the report and vaccination. The patient had no covid prior vaccination. Concomitant medications included acetylsalicylic acid (ASPIRIN 81, 81 mg tablet) at 81 mg, once a day; cyanocobalamin (B12-VITAMIN), and colecalciferol (D3), all taken for an unspecified indication, start and stop date were not reported. The patient previously took antihistamines, cephalexin (CEFALEXIN), amoxicillin but experienced allergies. The patient had no other vaccine in four weeks. Few minutes after shot, 04Mar2021 at 07:15 PM, patient felt slightly dizzy for few seconds then felt fine until 6 hrs after injection while sitting watching tv, wherein sudden strange feeling in head like wave washing over, then intense feeling of sudden diarrhea. Patient went to toilet, nothing happened, then everything went black and collapse but not unconscious. Patient went back on toilet, normal BM, no diarrhea, with nausea, profuse sweating soaks clothes, weak all over, shaking with chills, couldn't get up or will black out again, ringing in ears. These lasted total 20-30 minutes. Patient was also exhausted, fatigued, went to bed, and woke up 4 a.m. Her arm hurt but felt ok (Mar2021). Patient was weak, fatigued all day. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatments for the events reported. The patient was not tested for COVID post vaccination. The outcome of the events was reported as recovered in Mar2021.
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| 65 | 2021-03-28 | nausea |
30 min post vaccine, patient developed slight dry cough and feeling of tightness in back of throat. ...
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30 min post vaccine, patient developed slight dry cough and feeling of tightness in back of throat. Noted hoarseness of her voice. Brought to medical area where she then noted flushing, warmth of skin on face, neck, upper arms and chest. Slight nausea. On exam, no abnormalities except flushed skin. Vitals remained normal and stable. Monitored vital signs, had epi pen ready and elected to send her to ED via EMS for further monitoring, esp given her long hx of anaphylaxis. No other tx provided at site.
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| 65 | 2021-03-28 | nausea |
feeling sick to my stomach ended up fainting onto bathroom floor; feeling sick to my stomach; arm fe...
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feeling sick to my stomach ended up fainting onto bathroom floor; feeling sick to my stomach; arm felt mildly painful as injection went in; severe chills; fever; fatigue; restless sleep; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 65-years-old via an unspecified route of administration on 08Mar2021 08:15 (lot number: EN6203) as single dose for covid-19 immunisation. Medical history included covid-19 (covid prior vaccination: yes) from 10Jan2021 to an unknown date. There were no known allergies. Concomitant medication included acetaminophen taken for an unspecified indication, start and stop date were not reported. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 65-years-old, administered on the left arm on 15Feb2021 08:15 (lot number: EL9264) for covid-19 immunisation and experienced very painful injection site, chills, fever and fatigue. The patient reported that when she had her second vaccine on 08Mar2021, her arm felt mildly painful as injection went in, as though never healed from previous shot. This time, within 3 hours of vaccine, she began to feel fatigue, then began to experience chills and fever. She drank plenty of fluids, and took acetaminophen about 6 hrs after injection. In the evening her temp was up to 101.2 (her normal 97.2) and she took Acetaminophen at bedtime. Had very restless sleep, and at 5 AM on 09Mar2021, she got up feeling sick to her stomach ended up fainting onto bathroom floor. Luckily uninjured, and felt better upon "coming to". She was very fatigued rest of day, then normal next day. The patient underwent lab tests and procedures which included body temperature: 101.2 on 08Mar2021. No treatment was received for the events. The patient recovered from the events on an unspecified date.; Sender's Comments: Linked Report(s) : Same reporter,patient,product/ 2nd dose;US-PFIZER INC-2021269674 Same reporter,patient,product/ 2nd dose
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| 65 | 2021-03-30 | diarrhea |
fever of 100.2; body aches; diarea; This is a spontaneous report from a contactable other health car...
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fever of 100.2; body aches; diarea; This is a spontaneous report from a contactable other health care professional (patient). A 65-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown, expiration date unknown), via an unspecified route of administration, administered in left arm on 31Jan2021 20:45 at the age of 65 years old as single dose for COVID-19 immunisation. Medical history included physciatrist. There were no allergies to medications, food, or other products. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included gemfibrozil (LOPID), dexlansoprazole (DEXILANT), estradiol, paroxetine hydrochloride (PAXIL), desvenlafaxine succinate (PRISTIQ) and trifluoperazine hydrochloride (STELAZINE). The patient received other medications within 2 weeks of vaccination. On 01Feb2021, 03:30, the patient experienced fever of 100.2, body aches, diarea. The patient assessed the events as non-serious. The adverse event resulted in emergency room. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient has not recovered from the events.
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| 65 | 2021-03-30 | diarrhea |
hallucination; stomach had been getting harder all day long; severe diarrhea; numbness in her hand/n...
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hallucination; stomach had been getting harder all day long; severe diarrhea; numbness in her hand/numbness in her feet up to her knees; little blue squares vibrating and pulsating on her wrists to her finger tips; Severe pain in her right hip; she was ready to pass out; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3302) via an unspecified route of administration, administered into the left arm on 06Mar2021 09:45 as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome. There were no concomitant medications. On 07Mar2021 at 17:30 patient's stomach had been getting harder all day long, she had severe diarrhea and when she was in the toilet she noticed numbness in her hand, numbness in her feet up to her knees, severe pain in her right hip. She also saw little blue squares vibrating and pulsating on her wrists to her finger tips, she was ready to pass out and thought that she might be having hallucination (AS REPORTED). She was trying to lift her hip off the toilet and just wanted to get to the floor to curl up in the fetal position. Then suddenly all these effects went away and she was fine the rest of the night and has been fine ever since. The patient was asking if these could be side effects of the vaccine or if it was just a part of her IBS. Outcome of events recovered on 07Mar2021.
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| 65 | 2021-03-30 | nausea, gastrointestinal disorder |
feeling strange; ill; headache; chills; intestinal issues; tiredness; nausea; This is a spontaneous ...
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feeling strange; ill; headache; chills; intestinal issues; tiredness; nausea; This is a spontaneous report from a contactable Consumer (patient herself). A 65-year-old female non pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown) via left arm on 09Feb2021 11:00, as a single dose for COVID-19 immunization in hospital. Patient's medical history included Multiple myeloma (in remission for the past seven years) and hemochromatosis. Concomitant medication include verapamil and reyvow. On 09Feb2021 12:00, the patient started feeling strange within one hour from receiving the vaccination. As the day progressed, the patient became ill and experienced horrible headache, chills, intestinal issues, tiredness nausea. Patient did not receive any treatment for the adverse event. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination was not diagnosed with COVID-19. Since the vaccination patient had not tested for COVID-19. Patient had not allergies to medications, food, other products. The outcome of the events was recovered on 11Feb2021. Information on the lot/batch number has been requested.
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| 65 | 2021-03-30 | nausea, vomiting |
fatigue; she threw up; her appetite is worse/lack of appetite; dizziness; nausea; This is a spontane...
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fatigue; she threw up; her appetite is worse/lack of appetite; dizziness; nausea; This is a spontaneous report from a contactable other hcp. A 65-years-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in Arm Right on 22Jan2021 (Batch/Lot Number: EL8982; Expiration Date: 31May2021) as SINGLE DOSE for covid-19 immunisation. Medical history included renal cancer from Sep2005 to an unknown date, nephrectomy from 05Oct2005 to an unknown date, spinal fusion surgery from 23Nov2020 to an unknown date, compression fracture from Dec2020 to an unknown date, spinal fusion surgery from 22Apr2020 to an unknown date, compression fracture from 2020 to an unknown date, neoplasm from an unknown date and unknown if ongoing, vertebral body replacement from an unknown date and unknown if ongoing, lung neoplasm malignant from an unknown date and unknown if ongoing, metastases to spine from an unknown date and unknown if ongoing. Concomitant medication(s) included fentanyl (FENTANYL) taken for pain from an unspecified start date and ongoing; oxycodone taken for pain, start and stop date were not reported; paracetamol (TYLENOL) taken for pain from 23Apr2020 and ongoing; calcium taken for supplementation therapy from an unspecified start date and ongoing; panax ginseng (GINSENGIN) taken for fatigue from an unspecified start date and ongoing; ascorbic acid, betacarotene, biotin, calcium, chloride, chromium, copper, folic acid, iodine, iron, magnesium, manganese, molybdenum, nickel, nicotinic acid, pantothenic acid, phosphorus, potassium, pyridoxine hydrochloride, riboflavin, selenium, silicon, thiamine, vanadium, vitamin b12 nos, vitamin d nos, vitamin e nos, vitamin k nos, xantofyl, zinc (CENTRUM SILVER WOMEN 50+) taken for supplementation therapy from an unspecified start date and ongoing; vitamin d3 (VITAMIN D3) taken for bone disorder from 02Jan2021 and ongoing; cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) taken for supplementation therapy from an unspecified start date and ongoing; vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for supplementation therapy from an unspecified start date and ongoing; tart cherry (TART CHERRY) taken for inflammation from an unspecified start date and ongoing. The patient experienced dizziness (non-serious) on 24Jan2021, nausea (non-serious) on 24Jan2021 with outcome of not recovered , she threw up (vomiting) (non-serious) on 28Jan2021, her appetite is worse/lack of appetite (appetite disorder) (non-serious) on 24Jan2021, fatigue (non-serious) on an unspecified date. The action taken in response to the event(s) for bnt162b2 was not applicable. Therapeutic measures were taken as a result of fatigue (fatigue). The outcome of the events dizziness, nausea, vomiting and appetite disorder were reported as not recovered, The outcome of the event fatigue was unknown.
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| 65 | 2021-03-30 | retching, nausea |
Seeing double; eye are puffy; high neutrophils; high sugar; Dizziness; Nausea; Dry heaves; The ER to...
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Seeing double; eye are puffy; high neutrophils; high sugar; Dizziness; Nausea; Dry heaves; The ER told them she had an allergic reaction; This is a spontaneous report from a contactable consumer (patient's husband). This 65-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6206), via intramuscular in the right arm, on 09Mar2021 (at 14:00) as single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9266) administered in the left arm on 15Feb2021 (at 14:00) for COVID-19 immunisation. Relevant medical history included psoriatic arthritis, chronic obstructive pulmonary disease (COPD), emphysema, blood pressure abnormal, blood cholesterol abnormal, blood potassium abnormal, sleep apnea (she used C-Pap machine). Past drug history included allergy to penicillin. Relevant concomitant medications included hydroxychloroquine sulfate (PLAQUENIL SULFATE) for psoriatic arthropathy, ixekizumab (TALTZ) for psoriatic arthropathy, levothyroxine sodium (SYNTHROID), rosuvastatin for blood cholesterol abnormal, ranolazine (RANEXA), losartan for blood pressure abnormal, carvedilol (COREG), clopidogrel bisulfate (PLAVIX), potassium chloride (KLOR-CON) for blood potassium abnormal, escitalopram oxalate (LEXAPRO) for blood pressure abnormal, furosemide, tiotropium bromide (SPIRIVA) for COPD, fluticasone propionate, salmeterol xinafoate (ADVAIR) for COPD, acetylsalicylic acid (ASPIRIN (E.C.)), salbutamol (ALBUTEROL HFA) for emphysema and COPD and oxygen. On 11Mar2021, the patient became dizzy and nauseous and it just got worse and worse. She had also dry heaves. On 12Mar2021, she took meclozine hydrochloride (ANTIVERT, NDC 65162 0441 10) and ondansetron hydrochloride (ZOFRAN, NDC 65862 0187 30). Finally, on 13Mar2021 she had dry heaves and felt like she was going to pass out so they took her to the emergency room (ER). At ER, a computerized tomogram (CT) of head was done and resulted negative and blood work was normal except for high neutrophils and high sugar due to her drinking ginger ale for the nausea. The ER treated her with a shot of ANTIVERT and ZOFRAN and then lorazepam (ATIVAN). ATIVAN helped her so they sent her home with a prescription for ATIVAN. On 15Mar2021 (on Monday), she was no better. She was still dizzy and nauseous although the nausea was getting better as she could keep food down; she couldn't get off the couch without getting dizzy; under her eyes are so puffy and she was seeing double this morning when she woke up. The ER told them she had an allergic reaction. She was not sick at all when she got the shots; she was perfect. She used a C-Pap machine for sleep apnea and had oxygen that she used as needed. The patient had recovered from dry heaves on 14Mar2021, from seeing double on 15Mar2021; the patient had not recovered from dizziness and eye are puffy. The patient was recovering from nausea while the outcome of the remaining events was unknown.
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| 65 | 2021-03-31 | vomiting, nausea |
Nausea; Vomiting; Feeling unwell; Severe fatigue/Fatigue extreme; she goes to bed at 6:30PM every ni...
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Nausea; Vomiting; Feeling unwell; Severe fatigue/Fatigue extreme; she goes to bed at 6:30PM every night and wakes up at 9:00AM the next day; like she had arthritis; Her hair has been falling out/Hair loss; Joint pain; Fingers were frozen; Couldn't eat; barely hydrated; Pain she had in her fingers/ Her toes hurt when she walks; It was hard for her to cook, wash clothes, and do anything; This is a spontaneous report from a contactable Nurse (Patient). A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2, intramuscular, administered in Deltoid Left on 16Feb2021, 13:15 (Batch/Lot Number: elg267) as SINGLE DOSE for covid-19 immunisation, at 65 years old. Medical history included ongoing Irritable bowel syndrome, she was diagnosed with IBS (irritable bowel syndrome) 15 years ago (unspecified date); Blood pressure high from 2000 and ongoing, High cholesterol from an unknown date (she has had high cholesterol for about 4-5 years or longer), depression from an unknown date (she was diagnosed with depression in her 30s after a car accident. She said she has had post-traumatic stress and depression for years); type 2 diabetes mellitus from an unknown date (she has had Type 2 Diabetes for a while. She said she couldn't take the diabetes medicine. She said she didn't say much to her doctor about the diabetes medicine. She said she tried all different medicines for her diabetes. She said her current doctor had been treating her Type 2 Diabetes for almost 4 years now); post-traumatic stress from an unknown date. Patient received the first dose of BNT162B2 on 29Jan2021 13:15, 65 years old, (lot number el9262) for covid-19 immunisation and experienced back pain, fatigue, alopecia, malaise, arthralgia, nausea, vomiting, feeling abnormal, musculoskeletal stiffness, arthritis, illness, hypersomnia and fluid intake reduced. There were no concomitant medications. The patient had her second COVID-19 vaccine on 23Feb2021. On 23Feb2021, patient experienced feeling unwell. She has never been so sick; and severe fatigue/fatigue extreme. She got her second COVID-19 Vaccine shot her tiredness was worse. Reported with the regular flu vaccine she had felt bad for maybe 3-4 days, but nothing like how she felt after getting the COVID-19 Vaccine. Reported after she received her second COVID-19 Vaccine on 23Feb2021, she didn't feel good. She said she had such severe fatigue that she goes to bed at 6:30PM every night and wakes up at 9:00AM the next day. She said her fatigue improved a little last week, but she had to take a nap after anytime she went to do something. Reported it had been 10-12 days since she had her second COVID-19 Vaccine, and she was still so tired. She is tired all of the time. Her tiredness was worse. She was tired and went to bed. She said the next morning she was tired, and then the next day she was really tired. She said the following day got so bad; she was in bed for 2 weeks. She said she only got out of bed to go to the bathroom and get something to drink and a few crackers to nibble on. She said she had such severe fatigue that she goes to bed at 6:30PM every night and wakes up at 9:00AM the next day. She said her fatigue improved a little last week, but she had to take a nap after anytime she went to do something. She said she had gone to her doctor yesterday and was exhausted when she got home. She said she didn't eat anything when she got home from her doctor appointment and went straight to bed. She said she woke up at 5:30AM today. She said she was exhausted from just going to a doctor's appointment. On 25Feb2021, patient experienced nausea and vomiting. She said she had severe nausea and vomiting, clarifying that the nausea and vomiting lasted 2 weeks. Treatment was Phenergan Syrup 6.25mg/5ml every 6 hours, as needed. She said the Phenergan was originally prescribed for IBS. She said the Phenergan Syrup was dispensed in a pharmacy bottle, and didn't have a NDC, Lot, and Expiration Date. She said the Phenergan prescription label only had a printed barcode. Zofran 4mg tablet, as needed, three times a day. On an unspecified date in Feb2021, the patient experienced her hair has been falling out / Hair loss. She reported that her symptoms while a little better she is still tired all of the time, her hair is still falling out reporting, "If I roll it up in a clump its the size of a golf ball". She said after she got her second COVID-19 Vaccine on 23Feb2021, her hair loss was really bad. Hair Loss Treatment: She said the first thing she started taking was 1 Vitafusion Extra Strength Biotin 5000mcg Hair, Skin, and Nails Support. She stated she also took 2 Vitafusion Vitamin C 282mg Gummies a day. She said the product label said to take 3 Vitafusion Vitamin C 282mg Gummies per day, but she only takes 2 Gummies; Reported she was taking a multivitamin with Biotin and antioxidants every day. She said her doctor knew she was taking more than one vitamin and supplement and told her to watch out because she may be taking more than what was recommended. She said she stopped taking the multivitamin and now takes a regular vitamin. She said she also takes D3. She said her Fingers were frozen in a half closed position when she woke up in the morning. She said she had to work to open her fingers up. She said her fingers were sore, and she had to massage her fingers to get her fingers to unstick; Couldn't eat and was barely hydrated. She said she didn't eat anything when she got home from her doctor appointment and went straight to bed; Pain she had in her fingers/ Her toes hurt when she walks, she never hand been like this before. She said every joint in her body ached like she had arthritis. She said her toes, ankles, knees, fingers, and arms ached. She said she still has the joint pain happening. She said her fingers were sore. Treatment: Reported when she was at her doctor appointment yesterday, she asked her doctor for a Prednisone prescription for her joint pain. She said her doctor gave her a 6 day prescription of Prednisone 50mg tablets. She said she was dispensed 6 Prednisone 50mg tablets and is to take 1 Prednisone 50mg tablet a day for 6 days; It was hard for her to cook, ash clothes, and do anything. She said she was just laying bed with an ice pack, or a heat pack, and taking pain pills. She said she told her doctor she had called the Health Department, and the CDC. She said the Health Department didn't want to tell her anything, and the CDC will only talk with someone who has had an anaphylactic reaction to the COVID-19 Vaccine. She said she asked her doctor how long she was going to have the side effects. She said her doctor said that all of her patients who had any reaction to the COVID-19 Vaccine, had mostly had called into her office to ask about the COVID-19 Vaccine side effects, and most of the patients COVID-19 Vaccine side effects resolved in a week. She said her doctor said not one of her other patients had ever told her about the kind of side effects she was having. She said her doctor told her she must be in the 2% group and to call Pfizer to report her side effects. She asked how long the events would last and what can she take. The patient underwent lab tests and procedures which included cardiac stress test: all was good right now (unspecified date). Therapeutic measures were taken as a result of her hair has been falling out/hair loss, like she had arthritis, nausea, vomiting, joint pain (arthralgia). Events did not require visit to emergency room. Outcome of the event hair loss was not recovered; outcome of feeling unwell, severe fatigue/exhausted, joint pain was recovering; nausea and vomiting was recovered on an unspecified date; and outcome of all other events was unknown. The patient considered the events as related. The reporter considered the events as serious - medically significant.; Sender's Comments: Based on a temporal association and known drug safety profile, the causal association between the events and the suspect drug BNT162B2 cannot be totally excluded. Possible contribution from patient's underlying medical condition is also considered. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated a part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees, and Investigators, as appropriate.
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| 65 | 2021-04-01 | nausea, vomiting |
Nausea; Vomiting; Feeling unwell; severe pain in all my joints, toes, ankles, knees and my arms shou...
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Nausea; Vomiting; Feeling unwell; severe pain in all my joints, toes, ankles, knees and my arms shoulders fingers; didn't feel good; her fingers were frozen in a half closed position when she woke up in the morning; her body ached like she had arthritis; she couldn't eat and was barely hydrated; Hair loss; she couldn't eat and was barely hydrated; Tiredness/Fatigue extreme; Backache; "I'm so tired I go to sleep at 18:30 in the evening and don't wake up until 09:00 the next morning; sick; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: el9262, Expiration Date: Unknown) via intramuscular route of administration in left deltoid on 29Jan2021 (at the age of 65-year-old) at 13:15 as a single dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: unknown, Expiration date: Unknown) via an unspecified route of administration on 23Feb2021 as a single dose, both the doses for COVID-19 immunization. The patient medical history included Irritable bowel syndrome diagnosed 15 years ago (ongoing), ongoing Blood pressure high from an unknown date in 2000, high cholesterol for about 4-5 years or longer, depression (diagnosed in her 30s after a car accident), Type 2 diabetes mellitus (she couldn't take the diabetes medicine. She said she tried all different medicines for her diabetes. She said her current doctor had been treating her Type 2 Diabetes for almost 4 years now), post-traumatic stress, she was bedridden for 2 weeks on an unknown date in feb2021 (only able to get up to go to the bathroom), it was hard for her to cook, wash clothes, and do anything on an unknown date in Feb2021. The patient underwent stress tests, and all was good right now. The patient did not receive any additional vaccines administered on same date of the Pfizer Suspect was none. The concomitant medication was not reported. The patient previously took historical vaccine, flu vaccine on an unknown date for immunisation and felt bad for 3-4 days. It was reported that after first dose patient has been so sick. The patient experienced back pain on 29Jan2021. She reports that starting the next day that was on 30Jan2021, she has experienced severe fatigue extreme and tiredness. She reports that her symptoms while a little better she is still tired all of the time. She reports "I'm so tired I go to sleep at 18:30 in the evening and don't wake up until 09:00 the next morning on an unknown date in Jan2021. Caller also reports, my joints are in severe pain in all my joints, toes, ankles, knees and my arms shoulders fingers on an unknown date in Feb2021. My fingers are closed, and I can't straighten them out when I wake up". The patient put ice on her back and took pain pills and stuff. It was reported that patient had undergone back tests and result was not reported. The patient reported that she took she took Norco, or Hydrocodone/Acetaminophen 10mg/325mg. said her Norco 10mg/325mg prescription was for 1 Norco 10mg/325mg tablet every 6 hours, as needed, for pain. She said she normally would take 1 Norco 10mg/325mg tablet during the day, and another Norco 10mg/325mg tablet at bedtime. She said after her first COVID-19 Vaccine dose, she had been taking a Norco 10mg/325mg tablet every 6 hours. She said she also took a muscle relaxer, Tizanidine 4mg tablet. She said she took 1 Tizanidine 4mg tablet with the Norco 10mg/325mg tablet, three times a day. She said her backache felt like a belt across her lower back. She said when she has a backache, she gets off her feet, and puts her legs up on a pillow to take pressure off of her back. She said she rested, as well, but tried to do stuff around her house. She said she did have some tests on her back, and she had a fractured facet in her lower spine around the L1 vertebrae. She said she had to have some more tests done on her back. She said the backache she experienced after getting her COVID-19 Vaccine was not normal backache pain. It was Reported about 5-6 days after getting her first COVID-19 Vaccine, that was on an unknown date in Feb2021, her hair started falling out and the severity was explained by patient as "If I roll it up in a clump it's the size of a golf ball". She clarified she would brush her hair and would end up having hair everywhere (in her brush, on the counter, and floor). She said the day after she first noticed her hair falling out, she had even more hair fall out than normal. She said she was worried about her hair falling out and took Biotin and vitamins. She said after she got her second COVID-19 Vaccine on 23Feb2021, her hair loss was really bad. The patient took 1 vitamin Extra Strength Biotin 5000mcg Hair, Skin, and Nails Support (UPC Number: 2791700026, Lot Number: WA01802798, Expiration Date: Dec2021). She stated she also took 2 Vitamin C 282mg Gummies (UPC Number: 2791702071, Lot Number: WAO1887038, Expiration Date: Jan2022) a day. She said the product label said to take 3 Vitamin C 282mg Gummies. She stated she also takes 2 Calcium (UPC Number: 2791701951, Lot Number: YY01548358, Expiration Date: Jun2022) 500mg per day. Reported she was taking a multivitamin with Biotin and antioxidants every day. She said her doctor knew she was taking more than one vitamin and supplement and told her to watch out because she may be taking more than what was recommended. She said she stopped taking the multivitamin and now takes a regular vitamin. She said she also takes D3. Reported she was still tired. She clarified after she got her first COVID-19 Vaccine, she had felt tired for a few days with her back bothering her. She said she would get up and take her pain medicine, go to the bathroom, and get something to drink and go back to bed. She said she had felt a little better but wanted to take a nap every day. She said after she got her second COVID-19 Vaccine shot her tiredness was worse. Reported after she received her second COVID-19 Vaccine on 23Feb2021, she didn't feel good. She clarified when she got home from her second COVID-19 Vaccine she was tired and went to bed. She said the next morning she was tired, and then the next day she was really tired. She said the following day got so bad, she was in bed for 2 weeks. She said she only got out of bed to go to the bathroom and get something to drink and a few crackers to nibble on. She said her fatigue improved a little last week, but she had to take a nap after anytime she went to do something. She said she had gone to her doctor yesterday and was exhausted when she got home. She said she didn't eat anything when she got home from her doctor appointment and went straight to bed. She said she was exhausted from just going to a doctor's appointment. Reported every joint in her body ached like she had arthritis. She said her toes, ankles, knees, fingers, and arms ached. She said she still has the joint pain happening. She said her fingers were frozen in a half-closed position when she woke up in the morning. She said she had to work to open her fingers up. She said her fingers were sore, and she had to massage her fingers to get her fingers to "unstick." Reported when she was at her doctor appointment yesterday, she asked her doctor for a Prednisone prescription for her joint pain. She said her doctor gave her a 6day prescription of Prednisone 50mg tablets. She said she was dispensed 6 Prednisone 50mg tablets and was to take 1 Prednisone 50mg tablet a day for 6 days. Reported she had severe nausea and vomiting on 25Feb2021 and clarified that the nausea and vomiting lasted 2 weeks. She said she took Phenergan and Zofran around the clock. She said she couldn't eat and was barely hydrated. Zofran 4mg tablet (NDC Number: 65862-187-30, Lot Number: OND420010-A, Expiration Date: Jun2024), as needed, three times a day. She said the Zofran was dispensed in a white manufacturer's bottle. Reported she needed to have some regular blood work done. The seriousness of the events Backache, Tiredness/Fatigue extreme, Hair loss, Feeling unwell, Joint pain, Nausea and Vomiting were reported as serious (medically significant) by the reporter. The final outcome of the events Backache, Tiredness/Fatigue extreme, Hair loss was not recovered; Feeling unwell, severe pain in all my joints, toes, ankles, knees and my arms shoulders fingers, Nausea, Vomiting was recovering; didn't feel good, her fingers were frozen in a half-closed position when she woke up in the morning, her body ached like she had arthritis, she couldn't eat and was barely hydrated, sick and "I'm so tired I go to sleep at 18:30 in the evening and don't wake up until 09:00 the next morning was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product to the development of reported events cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 65 | 2021-04-01 | nausea |
4/1/21: patient presented with chief compliant of left-sided epistaxis (nose bleeding). Patient sta...
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4/1/21: patient presented with chief compliant of left-sided epistaxis (nose bleeding). Patient states she has had epistaxis on and off for the past 5 days. Stated she feels nauseas from the blood in the back of her throat. Significant active heavy bleeding from the left nare was confirmed. Per the EUA, hospitalizations to be reported irrespective of attribution to vaccine
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| 65 | 2021-04-03 | vomiting |
4 Days after vaccine, mild to increasing dizziness, vertigo, ringing in ears (tinnitus), resulting ...
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4 Days after vaccine, mild to increasing dizziness, vertigo, ringing in ears (tinnitus), resulting in going to hospital 1 week after first vaccine with extreme dizziness, vomiting, tinnitus. Loss of hearing in left ear going from no hearing to minimal hearing over 10 weeks. 2 hospital visits (one 7 days after first vaccine, 2nd one 4 weeks after 2nd vaccine. Prescribed Meclizine. 10 weeks since first vaccine. Still experiencing extreme dizziness, vertigo, tinnitus, loss of hearing in left ear. First vaccine 01/22/2021 Second vaccine 02/12/2021
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| 65 | 2021-04-04 | nausea |
After Dose 2 got my monthly nucala injection on 2/15 I started getting muscle spasm/ cramping in lef...
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After Dose 2 got my monthly nucala injection on 2/15 I started getting muscle spasm/ cramping in left foot was painful and very high anxiety. I started exp cramping in my lower arms I have been to ER, PCP, Ophthalmologist and Neurologist. I'm having terrible headaches as well. The Opthamologist applied eye drops that cause me to go to ER on 4/2 had blood work, checked pressures in eyes, prescribed medications nausea/dizziness, pain in my head and IV for low sodium.
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| 65 | 2021-04-06 | diarrhea, nausea |
Nausea; fever; chills; headache; tired; diarrhea which led to loss of fluids; low blood pressure; Th...
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Nausea; fever; chills; headache; tired; diarrhea which led to loss of fluids; low blood pressure; This is a spontaneous report received from a contactable consumer. A 65-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 18Mar2021 09:30 am (Batch/Lot Number: En6204) as single dose for covid-19 immunisation. Medical history included high blood pressure. The patient's concomitant medications within 2 weeks of vaccination were not unspecified. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously received cefaclor (CECLOR) and experience allergies, and also received first dose of BNT162B2 (Lot number= En6200) on 25Feb2021 09:30 AM at single dose at left arm for COVID-19 immunization. The patient experienced nausea, fever, chills, headache, tired and diarrhea which led to loss of fluids and low blood pressure in Mar2021 08:00 PM with outcome of recovering. The adverse events resulted in hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage, emergency room/department or urgent care. Patient received treatments for the events included fluids, medicine, partial colon removal. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had been tested for COVID-19: negative in Mar2021. Additional information has been requested.
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| 65 | 2021-04-07 | abdominal discomfort, diarrhea |
Not feeling well; legs were restless from hips down; fatigue; sore achy body; aching joints and musc...
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Not feeling well; legs were restless from hips down; fatigue; sore achy body; aching joints and muscles throughout body; aching joints and muscles throughout body; Chills; felt "heavy & on-fire" though cool to the touch (neuropathy); diarrhea; Headache; lower GI distress; muscle cramping all over body; Low-grade fever/temperature 100.9; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 17Feb2021 (Batch/Lot Number: EN5318) as single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included osteoarthritis and upper gastrointestinal (GI) distress. Concomitant medications included omeprazole (PRILOSEC) taken for upper gastrointestinal (GI) distress, start and stop date were not reported; celecoxib (CELEBREX) taken for an unspecified indication, start and stop date were not reported; colecalciferol (D3) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (B12) taken for an unspecified indication, start and stop date were not reported; calcium carbonate (CAL) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (lot number: EL3249) on 27Jan2021 04:30 PM at left arm. Other vaccine in four weeks reported as no. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Allergies to medications, food, or other products reported as no. These symptoms persisted for 24hours: on 18Mar2021 the patient was awoke midnight with chills, severe lower GI distress, diarrhea, head ache, muscle cramping all over body, legs felt heavy and on-fire though cool to the touch; temperature 100.9. Second 24 hours: the patient had low-grade fever, diarrhea, head ache, aching joints and muscles throughout body, continued lower GI distress. After 48 hours: the patient had temperature normal, sore achy body, head ache, fatigue. Consumed only water during first 72 hours then resumed liquids (broth, ginger ale) intake. Effectively treated diarrhea with loperamide hydrochloride (IMMODIUM); dicycloverine hydrochloride (BENTYL) for lower GI distress; resumed omeprazole (PRILOSEC) for upper GI distress. The patient returned to work on 23Mar2021 half-day, 24Mar2021 full-day still not feeling well. On 24Mar2021 during the night, legs were restless from hips down, felt "heavy and on-fire" though cool to the touch (Neuropathy) was similar to first night on 18Mar2021. On 26Mar2021, all symptoms have disappeared and the patient felt good, again she was in very good general health, active, appropriate weight, never ill. Events reported as non-serious. Events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the event fever was recovered on 20Mar2021, of other events was recovered on 26Mar2021.
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| 65 | 2021-04-08 | vomiting, nausea |
On Apr. 3 I had vertigo and fell on my back in the bedroom. 15 minutes later I started vomiting and ...
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On Apr. 3 I had vertigo and fell on my back in the bedroom. 15 minutes later I started vomiting and nausea and then went to the Emergency room. Hospitalized for 5 days. Discharged on Apr. 7 but still very weak and need help getting up or lying down.
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| 65 | 2021-04-14 | diarrhea |
Severe diarrhea starting the evening after having received the vaccine in AM. Diarrhea severe for Fr...
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Severe diarrhea starting the evening after having received the vaccine in AM. Diarrhea severe for Friday and Saturday. Patient became weak late on Saturday and husband insisted on trip to ER late in the evening and patient presented in hypovolemic shock with hepatorenal syndrome and severe metabolic acidosis and eventually to include lower GI bleed heralding ischemic colitis and requiring subtotal colectomy. Colon surgery complicated by post-op oozing and return to the OR. Returned stabilized. Has now progressed to SNF for recovery with Ileostomy and generalized weakness and blood loss anemia.
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| 65 | 2021-04-23 | abdominal pain, nausea |
Prolonged headaches; nausea; abdominal pain; This is a spontaneous report from a contactable nurse (...
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Prolonged headaches; nausea; abdominal pain; This is a spontaneous report from a contactable nurse (patient herself). A 65-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EN 5318), dose 1 via an unspecified route of administration, administered in left upper arm on 25Jan2021 at 12:45 as single dose for covid-19 immunization. Medical history included cardiac disorder, hypertension, type 2 diabetes mellitus, hypothyroidism, drug hypersensitivity and allergies to Ace inhibitors. Concomitant medication was not reported. No other vaccine in four weeks. No other medications in two weeks. On 25Jan2021, at 04:00 pm patient experienced prolonged headaches, nausea and abdominal pain. On 01Feb2021, the patient underwent lab tests and procedures which included sars-cov-2 test as negative. No covid prior vaccination. The treatment medications for the events included Zofran. The patient was recovered from the all events.
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| 65 | 2021-04-26 | difficulty swallowing |
tingle in lips; dry mouth; swallowing differences; slight fever; headaches; tried; muscle aches; Thi...
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tingle in lips; dry mouth; swallowing differences; slight fever; headaches; tried; muscle aches; This is a spontaneous report from a contactable consumer (patient). A 65 Years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6203), via an unspecified route of administration in left arm on 28Feb2021 at 10:00 AM at single dose for COVID-19 immunisation. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: (ID) 9809), via an unspecified route of administration in left arm on 07Feb2021 at 10:00 AM at single dose for COVID-19 immunisation and experienced head rush immediately after injection, extremely sore arm from first dose. Medical history included COVID 19 and allergic to flagyl, ciprofloxacin. The patient did not received other vaccine in four weeks. The patient did not tested for covid tested post vaccination. Concomitant medications included amlodipine besilate at 2.5 mg, metformin hydrochloride (METFORMIN ER) at 500 mg. On 28Feb2021 at 10:15 PM, the patient experienced tingle in lips, dry mouth, swallowing differences, slight fever, headaches, tried, muscle aches. No treatment was received. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 65 | 2021-04-27 | abdominal pain, vomiting |
April 22, 2021 morning my auntie got her first dose of Pfizer vaccine. She happily shared here vacci...
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April 22, 2021 morning my auntie got her first dose of Pfizer vaccine. She happily shared here vaccine experience with family member and relative. April 23 morning, she told us she has severe abdominal pain, has the need to have a bowel movement, but she was defecated. She also told us that she vomit couple times already, then she has no more energy to talk. She got into the hospital and she was announced death right after midnight at 12:04 April 25th. Reason of death given is "septic shock secondary to ischemic bowel & intra-abdominal sepsis". But it is the blood clots issue that is causing it. I was told that after my auntie got into hospital the very next day after Pfizer vaccine, hospital later found out that my auntie has blood blockage issue that is causing blood couldn't flow to her intestines. The acid in her blood was very high, 6+. After more than 6 hours without blood to her intestines, her intestines tissues start dying and turned black color. Doctor found out about this at the night of April 23, 2021 nighttime. April 22, 2021 morning is the day my auntie got her Pfizer covid vaccine. There is a very high chances of the Pfizer vaccine is causing the blood clots that lead to blood blockages.
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| 65 | 2021-04-30 | nausea |
coughing up blood; Coughing; Nausea; Headache; extreme fatigue; acute pain on the left side, she tho...
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coughing up blood; Coughing; Nausea; Headache; extreme fatigue; acute pain on the left side, she thought she cracked her rib/ rib pain; acute pain on the left side, she thought she cracked her rib/ rib pain; didn't sleep at all; difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8757) at the age of 65-year-old, via an unspecified route of administration on left arm on 31Mar2021 at 13:00 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. There were no additional vaccines administered on the same date and no vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously took aspirin and experienced allergy which was described as deadly. She never took medications since she found that out at 16-year-old. The patient received her first shot on 31Mar2021 at a pharmacy and mentioned that she was not sick at the time of vaccination, but she had a violent reaction to it. When she received it, she didn't feel anything. People said you will get a sore arm, but she got none of that. Then in the middle of the night on Friday (02Apr2021) probably around 3:00, she woke up with acute pain on the left side, it was rib pain, she thought she cracked her rib. On the same day, she also experienced difficulty breathing, and didn't sleep at all. On Saturday morning (03Apr2021), when she woke up, she had nausea, a headache, and extreme fatigue, but wondered if the extreme fatigue was because she did not sleep. The nausea and headache went away 8 hours later, on the same day. On Sunday (04Apr2021), she was coughing and coughed up blood. When she coughed, there was blood in the mucous. She mentioned that she still has acute pain, she could not get comfortable. Her sister passed away in January and she had a 5 pm train she was supposed to catch, she was responsible for the funeral. She was thinking that if she went to a hospital, they would keep her for 24 hours, she could maybe make it to the funeral but that was questionable. By Monday (05Apr2021), the acute pain was gone, she still had a cough, there was still blood in the mucous, she has occasionally blood in the mucous. The cough has not gone away but she was getting better every day. The difficulty breathing continued until about 08Apr2021 (as reported), but she still has some shortness of breath, but nowhere near as bad. She consulted her notes and said she was at 30% on 03Apr2021 and she felt today that she was at 80% and every day she was a little better and better. She has to sleep upright, she was afraid to sleep flat, she slept in her chair, last night for 2 nights she slept upright in her bed. She probably could lay down, but she was more comfortable upright. Because she was sleeping upright, she was not fatigued, she was not sleeping well but she didn't think that has anything to do with what was going on. The events did not result in emergency room or physician office visit. She is supposed to get her second dose on 21Apr2021but she did not want to get the second shot. She asked if she could wait and get the one shot from Johnson & Johnson. She didn't know where to go anymore. The outcome of the event "acute pain on the left side, she thought she cracked her rib/ rib pain" was recovered on 05Apr2021, recovered on 03Apr2021 for "nausea" and "headache", recovered on Apr2021 for "extreme fatigue", not recovered for "didn't sleep at all", and recovering for all other events.
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| 65 | 2021-05-04 | abdominal distension, abdominal pain upper |
Second vaccine not in list, COVID Pfizer done on 2/3/21 and 2/24/21 all info in my descriptions. Sh...
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Second vaccine not in list, COVID Pfizer done on 2/3/21 and 2/24/21 all info in my descriptions. Shingles shot at pharmacy given above and in my description. 4/5/21
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| 65 | 2021-05-04 | diarrhea |
leg was bruised; heart spasms; Diarrhea; inflammation along the major vein in her leg; heart palpita...
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leg was bruised; heart spasms; Diarrhea; inflammation along the major vein in her leg; heart palpitation; light headed/dizzy; severe muscle pain; tenderness and soreness in her inner thigh of the left leg/throbbing pain; Chills; This is a spontaneous report from a contactable consumer (patient, self-reported). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6208), via an unspecified route of administration in unspecified arm on 09Mar2021 (12:00) at single dose for Covid-19 immunization. The patient's medical history included ongoing hypothyroidism. Concomitant medication included levothyroxine been taking for 10-11 years for hypothyroidism. On 17Mar2021, Wednesday, the patient received the vaccine and had chills. On 18Mar2021, the patient had tenderness and soreness in her inner thigh of the left leg. On 19Mar2021, the patient had severe muscle pain on her calf of leg to inner thigh and it was throbbing so bad behind her knee on her left leg that she called her physician, and a sonogram was performed on 23Mar2021 which had found there was not a blood clot but there was severe inflammation along the major vein in her leg. On 20Mar2021, the patient had heart palpitation, her doctor told her to drink water and propel, she had heart spasms for 6 hours and felt lightheaded and dizzy. she thought she would go to the hospital, but she lives in a rural community and felt it did not make sense to go to the hospital. Palpitations and tenderness recovering. Her doctor and she was put on a heart monitor for her heart palpitations. She had heart palpitations with her hypothyroid but, this was totally different when she has had heart palpitations in the past. On an unknown date in Apr2021, the patient had diarrhea for 6 days. Patient had not been back to the doctor, but the nurse thought it was ok for her to take the second vaccine, but the patient was not comfortable with it. No prior vaccinations within the week. The patient never taken the flu shot. She had never received the flu vaccine or pneumonia nothing, so this was new for her getting the COVID vaccine. Caller clarified the chills started the week after she received the vaccine on Wednesday 17Mar2021. Severe muscle pain: Caller stated this happened on the 19, 20, 21, and 22 as well as the throbbing pain and then the next day on Monday 22Mar2021 she went to call her doctor and had a sonogram that next day on Tuesday (23Mar2021). Caller stated she still had the muscle pain in her left leg on the inner thigh but it was more so when she was active and once in a while she felt like her leg was bruised for a day or two but then it went away and she did not have a blood clot. Left leg throbbing: Caller stated this continually got worse and then on Sunday she felt so bad she laid in bed with her knee up and it throbbed like crazy. Caller stated this stopped about 2 days after she got the sonogram and it was not that severe it was just really tender and sore. Heart palpitation: Caller clarified that the heart murmurs she referred to earlier was actually heart palpitations. Caller stated this started at 8 in the morning and then at 10 in the morning she started getting light-headed and thought about going to the emergency room and figured no she will get through this. Caller stated she called her physician for the heart palpitations on Monday and she saw her doctor the following Tuesday and that is when her doctor had given her the heart monitor. Caller stated for 6 hours she felt horrible on Saturday since she knows the difference from her normal heart palpitations from her thyroid. Diarrhea: Caller stated this last for 6 days and was last week or so. Treatment: Caller stated no she is not a medicine taker she does not even take Tylenol or Advil unless it is a necessity. Outcome of the event chills recovered on 18Mar2021, tenderness and soreness in her inner thigh of the left leg/throbbing pain was resolving, severe muscle pain and inflammation along the major vein in her leg was not resolved, heart palpitation was resolving, light headed/dizzy was resolved on 20Mar2021, diarrhea was resolved on Apr2021, leg was bruised was resolved, heart spasms was unknown. No follow-up attempts are needed. No further information is expected. follow up(20Apr2021): New information was reported from a contactable consumer (patient) included: new events (coronary spasm, pain in extremity, phlebitis lower limb and bruising of leg) and event details. Case is upgraded to serious upon this follow up. No follow-up attempts are needed. No further information is expected.
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| 65 | 2021-05-04 | flatulence, diarrhea |
suppressed WBC and neutrophils and platelets; suppressed WBC and neutrophils and platelets; suppress...
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suppressed WBC and neutrophils and platelets; suppressed WBC and neutrophils and platelets; suppressed WBC and neutrophils and platelets; Very loose, sticky stool; Very loose, sticky stool; gaseous episodes; This is a spontaneous report from a contactable Other-HCP (patient). A 65-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3248), second dose intramuscular, administered in Arm Left on 08Jan2021 08:00 (at 65 years old, not pregnant) single dose for covid-19 immunisation. The patient had no relevant medical history. The patient had her first dose of bnt162b2 (lot number: EJ1685) on 18Dec2020 1500 for covid-19 immunisation, intramuscular on left arm. Concomitant medication(s) included colecalciferol (VIT D3); magnesium; calcium; ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS); chondroitin sulfate, glucosamine (GLUCOSAMINE CHONDROITIN; monascus purpureus (RED YEAST RICE). On 16Jan2021, patient experienced very loose, sticky stool, gaseous episodes everyday since 2nd shot in Jan2021. Patient still do not have normal solid stool today. Patient went into the hospital 23Mar2021 with suppressed WBC and neutrophils and platelets. Tested for every virus, fungus and autoimmune disease and all came back negative and then had a bone marrow biopsy with negative results. Inflammation was seen in biopsy study. Given Neupogen to increase WBC/neutrophils only once which raised levels. Released 5 days later. Blood test 4/13 showed below normal WBC/neutrophils again but not as severe. Still trying to get healthy again. Adverse event resulted in visit to Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. Five days of hopitalisation. The outcome of the events was Recovering.Patient was given treatment Bone marrow biopsy, injection of Neupogen, IV antibiotics. No Covid prior vaccination. Patient got Covid tested post vaccination, nasal swab on 21Mar2021, 21Mar2021 and 23Mar2021, all negative. No Known allergies.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events diarrhea, flatulence, abnormal feces, platelet count decreased, neutrophil count decreased and WBC count decreased and the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees, and Investigators, as appropriate.
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| 66 | 2021-01-04 | abdominal pain upper, diarrhea |
stomach cramps; diarrhea; chills; This is a spontaneous report from a contactable other healthcare p...
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stomach cramps; diarrhea; chills; This is a spontaneous report from a contactable other healthcare professional. A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at left arm on 24Dec2020 08:00 at single dose for Covid-19 immunization. The COVID-19 vaccine was administered in a hospital facility. Medical history included hypertension, and allergic to penicillin. The patient was not diagnosed with Covid-19 prior vaccination. Concomitant medication included amlodipine and irbesartan; both from unspecified date for unspecified indication. On 26Dec2020 22:30, the patient experienced stomach cramps, diarrhea and chills. The patient was not tested for COVID-19 post vaccination. The patient did not receive treatment due to the events. The outcome of the events stomach cramps, diarrhea and chills was recovering. The reporter considered the events non-serious; the events did not results in death, not life threatening, did not caused/prolonged hospitalization, was not disabling/incapacitating, not a congenital anomaly/birth defect. Follow-up activities are possible, information on the batch number has been requested.
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| 66 | 2021-01-04 | decreased appetite, nausea |
Starting the day after vaccine I have had extreme fatigue, nausea, decreased appetite. dizziness, mu...
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Starting the day after vaccine I have had extreme fatigue, nausea, decreased appetite. dizziness, muscle aches, chills. It has continued now for 14 days, without improvement. It is actually worsening.
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| 66 | 2021-01-04 | nausea |
Patient was experiencing headache, lightheadedness, generalized itching, shortness of breath, wheezi...
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Patient was experiencing headache, lightheadedness, generalized itching, shortness of breath, wheezing, and nausea after 8-10 minutes of COVID-19 vaccine administration. Vital signs were stable RR 22 and SpO2 96% on RA. She was speaking in full sentence, no acute distress, with expiratory wheezing. No central cyanosis or new rash. After 15 minutes, she reports improvement on her symptoms. She was given Benadryl po and Albuterol 2 puffs in the clinic with improvement on her symptoms. Lungs have more air movement and less wheezing after the albuterol treatment. She was send home and educated in ED precautions.
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| 66 | 2021-01-05 | abdominal pain upper, abdominal distension |
Severe stomach cramps; severe stomach cramps and bloating; This is a spontaneous report from a conta...
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Severe stomach cramps; severe stomach cramps and bloating; This is a spontaneous report from a contactable other hcp (patient). A 66-year-old female patient received first dose of BNT162B2 (Pfizer product, lot number: EK9231), intramuscular on 29Dec2020 16:00 at single dose on right arm for COVID-19 immunization. Medical history included penicillin allergy. Concomitant medication included chondroitin;glucosamine, biotin, vitamin d nos, zolpidem tartrate (AMBIEN) and Women's Daily Vitamin. The patient previously took codeine and experienced drug allergy. The patient experienced severe stomach cramps and bloating 19 hours after vaccine (30Dec2020 11:00). Took "Digestive Advantage" and symptoms let up after 1 hour. The patient did not receive other vaccine in four weeks. No covid prior vaccination; no covid tested post vaccination. The patient was not pregnant at the time of vaccination. Therapeutic measures were taken as a result of the events. The outcome of the events was resolving.
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| 66 | 2021-01-05 | nausea, retching |
severe chills, dry stinging mouth, headache, dehydration, dry heaves,nausea, for approximately 6 hrs...
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severe chills, dry stinging mouth, headache, dehydration, dry heaves,nausea, for approximately 6 hrs. The symptoms resolved then she experienced Headache, fatigue body aches until 01/06/2021 @0600.
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| 66 | 2021-01-05 | nausea | Severe headache and nausea |
| 66 | 2021-01-05 | nausea |
Significantly sore left shoulder (injection arm) with pain now radiating up into neck & downward aro...
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Significantly sore left shoulder (injection arm) with pain now radiating up into neck & downward around shoulder blade, severe headaches, nausea (no vomiting), sore throat, FATIGUE, chills/cold sweat, general body aches.
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| 66 | 2021-01-06 | diarrhea |
Awoke in the middle of the night with spiking fever 101.5, headache, muscle aches, diarhea, In bed f...
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Awoke in the middle of the night with spiking fever 101.5, headache, muscle aches, diarhea, In bed from Monday night to Wednesday morning started feeling better.
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| 66 | 2021-01-06 | nausea | Headache, nausea, really bad chills that woke her out of her sleep |
| 66 | 2021-01-08 | diarrhea |
SkinRash & Diarrhea Narrative: Hives general systemic, head, palms,right eye lid, back, abdomen. Hi...
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SkinRash & Diarrhea Narrative: Hives general systemic, head, palms,right eye lid, back, abdomen. Hives continued to pop up for the next four days.
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| 66 | 2021-01-09 | vomiting, nausea, blood in stool, gastrointestinal disorder | The concern was the gi symptoms,,,severe cramping nausea, vomiting and bloody stool |
| 66 | 2021-01-11 | nausea |
Felt very much like I was going to faint. Had nausea and without proper breathing and fighting thro...
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Felt very much like I was going to faint. Had nausea and without proper breathing and fighting through it, I would have passed out. And I was driving. The pain during the injection was one of the most severe I've ever had. It was injected in the top part of my shoulder where there is nothing but bone.
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| 66 | 2021-01-11 | nausea |
"45up to void min later sweat, 12hrs later when I woke up to void, I felt warm ,severe fatigue , ,...
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"45up to void min later sweat, 12hrs later when I woke up to void, I felt warm ,severe fatigue , ,muscle aches , pain some Syncope, nausea, sweating on and off, oral herpes outbreak just like I did when I had Covid -19 in April"
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| 66 | 2021-01-11 | nausea |
onset of severe headache, chills, nausea, fever to 101.5 and chest tightness (pulse ox dropped to 92...
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onset of severe headache, chills, nausea, fever to 101.5 and chest tightness (pulse ox dropped to 92% requiring treatment with albuterol several times during the day. Inset of symptoms occurred approximately 16 hours after vaccination. Fever and other symptoms began subsiding approximately 24-28 hours after vaccination.
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| 66 | 2021-01-11 | nausea | Injection site pain, chills, fever, headache, muscle pain, nausea 12 hours after second vaccine |
| 66 | 2021-01-11 | nausea |
The 'left side of her face went numb, and it crawled up from her chin to her eyebrow lasted 20 minut...
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The 'left side of her face went numb, and it crawled up from her chin to her eyebrow lasted 20 minutes and then went away'; she felt 'a wave of nausea; This is a spontaneous report from a contactable consumer for herself. This 66-year-old female patient received the first dose of BNT162B2 (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)) at single dose for COVID-19 immunisation on unknown date. Relevant history and concomitant drugs were unknown. The patient stated 3 hours after having received the vaccine, she felt 'a wave of nausea that went away just as fast as it had hit' her. The left side of her face went numb, and it crawled up from her chin to her eyebrow lasted 20 minutes and then went away. This was on the same side that she got the vaccine. She had never experienced anything like that. The outcome of event face went numb was recovered. The outcome of other events was unknown. Information about Batch/Lot number has been requested.
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| 66 | 2021-01-12 | vomiting, nausea |
fever T104.2, HR115, shivering, nausea, throat feels dry, vomiting Taking Tylenol Prescribed Zofran ...
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fever T104.2, HR115, shivering, nausea, throat feels dry, vomiting Taking Tylenol Prescribed Zofran by PMD Prescribed Ibuprofen by ED MD
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| 66 | 2021-01-13 | nausea, vomiting | chills, shaking, headache, neck ache, joint pain, nausea, vomiting |
| 66 | 2021-01-13 | nausea |
Day following: severe body aches, chills and fever and slight nausea. The second day following inje...
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Day following: severe body aches, chills and fever and slight nausea. The second day following injection felt a bit better but that evening night sweats and third day following quite nauseated.
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| 66 | 2021-01-13 | vomiting | RESIDENT BEGAN VOMITING AND BECAME UNRESPONSIVE AT 12PM. |
| 66 | 2021-01-14 | decreased appetite | Sore arm, loss of appetite, fatigue, extreme dizziness, drop in blood pressure |
| 66 | 2021-01-14 | nausea | Fatigue, body aches 1/12-13/21 and extreme nausea on 1/14/21. |
| 66 | 2021-01-14 | nausea |
2043-patient received 2nd dose; 2055- c/o dizziness, lightheadedness, nauseated. Patient has not eat...
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2043-patient received 2nd dose; 2055- c/o dizziness, lightheadedness, nauseated. Patient has not eaten since 0800 in the morning. 2100 Patient-given granola bar and water and reports feeling much better. Patient declined ED or Urgent care at this time. Patient to call if symptoms return.
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| 66 | 2021-01-14 | vomiting, nausea |
Fatigue, nausea, vomiting, fever, chills, headache, muscle aches. (All began immediately following 2...
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Fatigue, nausea, vomiting, fever, chills, headache, muscle aches. (All began immediately following 2nd dose and have continued to present day. However, as of 1/15/21 symptoms have begun to subside.)
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| 66 | 2021-01-15 | nausea, abdominal pain upper |
about 1 hour after shot i started getting bad stomach pain in the upper stomach and all over stomac...
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about 1 hour after shot i started getting bad stomach pain in the upper stomach and all over stomach and intestine cramps and 3 days later i still have them. also still have lots of nausea. body aches all over. swelling ankles more on right side, headache, fell sick all over. no treatment just staying in bed.
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| 66 | 2021-01-17 | diarrhea, abdominal pain |
Dizzy, burning sensation over body, lips tingling and tongue swelling, abdominal cramps and diarrhea...
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Dizzy, burning sensation over body, lips tingling and tongue swelling, abdominal cramps and diarrhea, impending doom feeling that something was really wrong, foggy brain Benadryl 50mgm, Epinephrine, Observation,
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| 66 | 2021-01-17 | diarrhea |
1/15/2021 11:00 p.m. developed orbital edema took Benadryl 75 mg PO. 1/16/2021 morning orbital edema...
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1/15/2021 11:00 p.m. developed orbital edema took Benadryl 75 mg PO. 1/16/2021 morning orbital edema improved but still present, shortness of breath, lips tingling, swollen tongue, facial numbness around mouth and cheeks. Benadryl 50 mg every 4-6 hours, Prednisone 10 mg, Tagement 1 pill (unknown dose), Afternoon developed GI symptoms cramping diarrhea took Bentil 20 mg 1/17/2021 Continued facial swelling Benadryl 50 mg 1/18/2021 Symptom resolution
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| 66 | 2021-01-18 | nausea |
Within minutes of receiving my first dose injection, my mouth and tongue began to itch and my tongue...
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Within minutes of receiving my first dose injection, my mouth and tongue began to itch and my tongue began to swell. I also had a headache and felt nauseous. Over time, I also had some difficulty breathing
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| 66 | 2021-01-20 | abdominal pain, vomiting, nausea |
Patient presented with worsening fatigue and shortness of air that began Friday(1/15/21) after recei...
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Patient presented with worsening fatigue and shortness of air that began Friday(1/15/21) after receiving COVID 19 vaccination. She has also had nausea, vomiting, and diffuse abdominal pain since that time. Patient has had a cough for last five days. Patient admitted to ICU for care on 1/17/2021.
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| 66 | 2021-01-20 | nausea |
Injection site pain; chills; fever; headache; muscle pain; nausea; This is a spontaneous report from...
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Injection site pain; chills; fever; headache; muscle pain; nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 66-year-old female patient received the second dose of BNT162B2 (Pfizer, lot number: EL3246), intramuscularly in left arm on 08Jan2021 09:30 at single dose for COVID-19 immunization. Medical history included known allergies: sulfa drugs. Concomitant medications were not reported. Patient previously received the first dose of BNT162B2 (lot number: EK5730), intramuscularly in left arm on 21Dec2020 17:00 for COVID-19 immunization. Patient experienced injection site pain, chills, fever, headache, muscle pain, and nausea 12 hours after second vaccine on 08Jan2021 22:00. No treatment was received. Patient was recovered from these events. No follow-up attempts are possible; no information is expected.
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| 66 | 2021-01-20 | nausea |
Nausea and feeling of wanting to vomit. Been resting, took Zofran and thought she was hungry, but s...
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Nausea and feeling of wanting to vomit. Been resting, took Zofran and thought she was hungry, but still having the same symptoms.
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| 66 | 2021-01-21 | decreased appetite | Severe weakness Extreme fatigue Loss of appetite |
| 66 | 2021-01-22 | nausea |
Nausea, headache, vertigo started 15 minutes after receiving vaccine. 24 hours later developed arm p...
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Nausea, headache, vertigo started 15 minutes after receiving vaccine. 24 hours later developed arm pain, generalized muscle aches. 36 hours after developed chills, fever 102.5, headache, fatigue 48 hours fatigue, muscle aches present but less fatigue lasted 5 days
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| 66 | 2021-01-24 | difficulty swallowing |
About 45 minutes after the injection there was a swelling of the back of my tongue and throat. It w...
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About 45 minutes after the injection there was a swelling of the back of my tongue and throat. It was difficult to swallow, but not difficult to breathe. I took 25 mg of Benadryl and 4 hours later took 50 mg of Benadryl. The swelling did not diminish, but did not get worse. When I woke up the next morning, everything was back to normal.
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| 66 | 2021-01-25 | abdominal pain, diarrhea, nausea, vomiting |
I had soreness in my arm for two days. I had onset on pain on the 28th, it was sudden and serve. I w...
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I had soreness in my arm for two days. I had onset on pain on the 28th, it was sudden and serve. I went to ER, nausea, vomiting's, diarrhea. They ran a bunch on test and everything came back negative. I had serve abdominal pain, I didn't have any treatment. On 1/2/21 I started antibiotics and was on them until 1/24/21. I'm still not sure if the pain had anything to do with the Covid vaccine.
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| 66 | 2021-01-25 | nausea, diarrhea | chills fever body aches nausea diarrhea headache |
| 66 | 2021-01-25 | nausea | Fever, body ache, HA, nausea, chills, tremors, O2 sat = 96% |
| 66 | 2021-01-25 | nausea |
Shot site on arm began hurting a lot around 1am the next day Jan 26. I began to feel nauseous the ne...
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Shot site on arm began hurting a lot around 1am the next day Jan 26. I began to feel nauseous the next day at 11 am. Also had some chills. Took Advil soon after and helped alleviate the chills right away. Received Pfizer-BioNTech COVID-19 Vaccine EUA
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| 66 | 2021-01-26 | diarrhea, abdominal pain | diarrhea, can't eat, 99 fever, dizzy, abdominal pain, muscle pain,fatigue |
| 66 | 2021-01-26 | nausea |
Patient Complained of feeling lightheaded 1 minute after vaccine administered. She bent over forward...
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Patient Complained of feeling lightheaded 1 minute after vaccine administered. She bent over forward in chair. Observation nurse called over and BP cuff applied. 0957=BP 97/58; radial pulse 60; skin warm dry and pink; 1002=complained of nausea, patient lowered to floor with legs bent; BP 96/60; 1005 nausea gone; epi pen administered in lateral left thigh; 1006 BP 104/70 radial pulse 68; 1008 BP 102/70 radial pulse 80; skin warm dry pink; EMS called and responded; transfer of care occurred at 1020am; patient refused to go to hospital; remained in our recovery area for 30 minutes post epinephrine injection. left with husband at 1040am. Vitals within normal limits.
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| 66 | 2021-01-27 | decreased appetite | Elevated blood pressure. Pressure in ears muffled hearing. Loss of appetite. |
| 66 | 2021-01-27 | diarrhea, abdominal pain upper, nausea | Severe nausea, diarhea, stomach pains, beginning 48 hrs from vaccination lasting 4 days |
| 66 | 2021-01-29 | abdominal discomfort | Extreme fatigue, unable to stand or walk, dizziness, physical weakness, upset stomach, |
| 66 | 2021-01-29 | abdominal pain upper | Stomach cramps |
| 66 | 2021-01-30 | abdominal pain upper, nausea |
This was my second dose of the Pfizer vaccine. First day I felt soreness on my left arm where shot...
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This was my second dose of the Pfizer vaccine. First day I felt soreness on my left arm where shot was administered and I had stomach cramps through the day. Had to eat very light. Woke up with an intense headache during the night, which continued all through Saturday 1/30/2021 and into the night. I started with a fever of 100.5 and it climbed to approximately 102 in late afternoon on Saturday. Saturday afternoon got nauseous and remained that way through the night. Most symptoms have stopped on Sunday morning, although my stomach is very unstable and I feel weak. I took Tylenol through the day and at midnight on Saturday at recommended doses or less. Temperature 99.1 on Sunday afternoon and haven?t taken a Tylenol since Saturday night.
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| 66 | 2021-01-31 | abdominal pain, nausea, abdominal pain upper |
severe upper stomach pains and stomach pains all over and cramps; all over body pain; headache; naus...
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severe upper stomach pains and stomach pains all over and cramps; all over body pain; headache; nausea; ankles swelling more the right one; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration in the right arm on 13Jan2021 13:00 at a single dose for COVID-19 immunization. Medical history included Coronary artery disease (CAD), 2nd degree AV heart block, acid reflux, gastritis, high blood presure, fibromyalgia, gammaglobulinemia, allergies to sulfa, eggs, milk, fish, shrimp, and nuts. The patient is not pregnant. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included valsartan (DIOVAN), esomeprazole sodium (NEXIUM), acetylsalicylic acid (BABY ASPIRIN), alprazolam, atorvastatin (LIPITOR). The patient previously took codeine, morphine, clopidogrel (PLAVIX), isosorbide mononitrate (IMDUR) and experienced allergies. On 13Jan2021 15:00, approximately 1 hour after the shot, the patient experienced severe upper stomach pains and stomach pains all over and cramps. A few hours later, she got all over body pain, headache, nausea, and her ankles were swelling more the right one. These events are all still going on 3 days later. Treatment was not provided in response to the events. The patient has not undergone COVID testing post vaccination. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 66 | 2021-01-31 | vomiting, diarrhea |
Within 3 hours: Dizziness, severe diarrhea, vomiting, loss of consciousness, rapid shallow breathing...
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Within 3 hours: Dizziness, severe diarrhea, vomiting, loss of consciousness, rapid shallow breathing, BP 87/40, called 911, went to E.R.
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| 66 | 2021-02-01 | nausea, vomiting | Headache, Nausea, Vomiting, Chills, Fatigue, Joint pain, Fever. |
| 66 | 2021-02-01 | nausea, vomiting |
This is a spontaneous report from a contactable consumer reporting for self. A 66-year-old female pa...
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This is a spontaneous report from a contactable consumer reporting for self. A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: CDR00811854), via an unspecified route of administration on 19Jan2021 14:15 at single dose for COVID-19 immunization. Medical history included depression, anxiety. Concomitant medication included levothyroxine, atorvastatin calcium (ATORVA), hydrochlorothiazide; lisinopril. The patient experienced Nausea, throwing up 3 times on 19Jan2021 18:15. Outcome of events was recovering.
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| 66 | 2021-02-02 | nausea |
Message from patietn: Due to other vaccine reactions I had to wait for 30 minutes after my shot. A...
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Message from patietn: Due to other vaccine reactions I had to wait for 30 minutes after my shot. All was okay, until I got in the car to drive home. My tongue began to tingle and headaches began. I immediately took an antihistamine as a tingly tongue for me is a sign of an allergic reaction. I then had a band like pain across my upper back, and then the chills, tiredness, nausea, sore throat, sore arm which are all normal reactions from the printed information - well except for the tingly tongue and a red rash across my nose, cheeks and chin. Tingling and rash subsided about an hour after taking the antihistamine, but all of the other symptoms remained. My shot was at 1:50 PM and just before 11 PM I had instant onset of pain in my chest wall with breathing. It went across the top of both breasts in the center where my ribs meet my sternum. This has lessoned with laying down, but when I am up and about it increases although not as bad as last night. I am also experiencing bursts of itchy spots all over. As I have an EpiPen I did not go to hospital but am wondering about what to do for the 2nd shot. I think it will be best if I take an antihistamine prior to the shot and I will continue taking them for this one until my symptoms go away.
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| 66 | 2021-02-02 | vomiting, nausea |
I started feeling very ill the evening of my second Pfizer shot. My symptoms included headache, musc...
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I started feeling very ill the evening of my second Pfizer shot. My symptoms included headache, muscle pain, chills, nausea, vomiting and fatigue. I felt very unwell for 4 days. By Feb 1st, I started to feel better.
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| 66 | 2021-02-04 | abdominal pain upper, GERD, vomiting |
Runny nose; feeling unwell; muscle & joint aches; muscle & joint aches; chills; tired; stomach cramp...
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Runny nose; feeling unwell; muscle & joint aches; muscle & joint aches; chills; tired; stomach cramps; acid reflux; vomiting; This is a spontaneous report from a contactable consumer, reporting for herself. A 66-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EK9231, via an unspecified route of administration on 20Jan2021 at 09:15 (at the age of 66 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included obese from an unspecified date, and cancer in 1998 & 2015. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included letrozole, vitamin (unspecified), Omega, 'TransResve', calcium, 'eld'. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Jan2021 at 12:00PM, the patient experienced runny nose, feeling unwell, muscle & joint aches, chills, tired, stomach cramps, acid reflux, and vomiting. The patient did not receive treatment for the events. The clinical outcome of runny nose, feeling unwell, muscle & joint aches, chills, tired, stomach cramps, acid reflux, and vomiting was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 66 | 2021-02-04 | nausea |
Developed runny nose, sneezing, muscle aches/joint pain, nausea, scratchy throat, sinus pressure, ra...
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Developed runny nose, sneezing, muscle aches/joint pain, nausea, scratchy throat, sinus pressure, rash on chest/neck, fatigue. Saw medical provider on 2/02/2021 who suspected above due to receiving 1st dose of covid-19 vaccine.
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| 66 | 2021-02-04 | nausea |
Noticed pt had a red face while waiting in the post vaccination area I asked if this her normal She ...
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Noticed pt had a red face while waiting in the post vaccination area I asked if this her normal She said no She reported , nausea, dizzy. I brought to the EMT area They assessed her Hr 75 oxygen sat 95% BP 179/93 epi administered Iv insertion attempted by EMT x2 no results Glucose 91 by EMT Pt sent to ED 955
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| 66 | 2021-02-06 | nausea |
On day 2 (2/6/21)developed cough, then chills & fatigue. By 3 pm went to bed. Woke up about 7pm, mil...
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On day 2 (2/6/21)developed cough, then chills & fatigue. By 3 pm went to bed. Woke up about 7pm, mild chills lasted until about 10pm. On Sunday 2/7/21 - still fatigue, mild nausea, sporadic headaches, but no chills, no fever.
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| 66 | 2021-02-06 | nausea | Tiredness (no energy) Headache Chills Fever 107 Injection site redness Nausea |
| 66 | 2021-02-07 | abdominal pain upper, vomiting | vomit once shakes |
| 66 | 2021-02-07 | difficulty swallowing |
difficulty swallowing approximately 40 minutes after receiving the vaccine. this lasted for about a...
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difficulty swallowing approximately 40 minutes after receiving the vaccine. this lasted for about an hour and resolved on its own. I did not receive medical treatment as I had already left the vaccination site.
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| 66 | 2021-02-07 | nausea, decreased appetite |
1/29-Reported increased fatigue, weak and itchy, hands were red and blotchy. MD updated and PRN Bena...
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1/29-Reported increased fatigue, weak and itchy, hands were red and blotchy. MD updated and PRN Benadryl given with good effect. C/O nausea and decreased appetite 1/30 received PRN Zofran with good effect. No further complaints 2/1
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| 66 | 2021-02-07 | nausea |
First Vaccine - produced fever, chills, headache, dizziness, nausea - lasted 2 days - Vaccine was a...
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First Vaccine - produced fever, chills, headache, dizziness, nausea - lasted 2 days - Vaccine was administered Sunday at 3:20 PM and I was sick Monday and all day Tuesday - by Wednesday I was fine Second vaccine was January 31st at 3 PM - the next morning I woke up - got in the shower - got nauseous dizzy and fell breaking my left leg and left ankle. I still had nausea for 6 days and headache for 6 days - seems better today
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| 66 | 2021-02-07 | nausea | Post 22 hours: headache tiredness nausea feeling unwell |
| 66 | 2021-02-07 | vomiting | headache, chill, tiredness, throwing up, low grade fever |
| 66 | 2021-02-08 | nausea | Dizziness, nausea, headache, fatigue |
| 66 | 2021-02-08 | nausea | Flu-like symptoms, light-headedness, nauseous, exhausted. No outcome to date - symptoms continue. |
| 66 | 2021-02-09 | abdominal pain |
48 hrs after vaccination developed severe abd/low back pain. Worked up for diverticulitis but all te...
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48 hrs after vaccination developed severe abd/low back pain. Worked up for diverticulitis but all tests were WNL. 8 days after vaccination she develop blisters on left lower back and abd area and was then dx with shingles and started on acyclovir.
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| 66 | 2021-02-09 | nausea, diarrhea |
Pt was brought by wheelchair from Covid Vaccine clinic where rapid response was called; pt reports 2...
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Pt was brought by wheelchair from Covid Vaccine clinic where rapid response was called; pt reports 2nd dose pfizer vaccine given; after obtaining chart pt reports "feeling flushed, and then redness/rash on chest, and blood pressure go up". Pt given epi during rapid response; Pt reported a headache at this time. Pt denies dizziness, nausea, diarrhea, sob, no facial swelling, no lip swelling; no dysphagia; RR equal non-labored; Alert and orientated x4;
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| 66 | 2021-02-09 | nausea |
sever joint pain hands, arms,shoulders; extreme fatigue; nausea; muscle fatigue; chills for 6 hours;...
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sever joint pain hands, arms,shoulders; extreme fatigue; nausea; muscle fatigue; chills for 6 hours; swollen lymph nodes left side; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration at the left arm on 22Jan2021 10:00 at single dose for COVID-19 immunization. Medical history included heart disorder (heart disease), hypertension, and obesity. The patient was not pregnant at the time of vaccination. The patient was diagnosed with COVID-19 prior to vaccination. The patient received other medications within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sever joint pain hands, arms, shoulders, extreme fatigue, nausea, muscle fatigue, chills (for 6 hours as reported), swollen lymph nodes left side all on 23Jan2021 02:00 with outcome of recovering. The patient did not received any treatment for the events.
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| 66 | 2021-02-09 | nausea |
Did the adverse event start after the first or second vaccination? both Date and time of vaccinatio...
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Did the adverse event start after the first or second vaccination? both Date and time of vaccination: (list both if they received both shots): 1-6-2021 @ approx 10:15am Pfizer LOT # EL3246 1-27-2021 @ approx 11AM Pfizer LOT # EL9262 Date and time adverse event started: 1-31-2021 at approx 8:30am, cold hands/feet, nausea, HA, pain to bilateral eye, mid lower back aches radiating to upper. today 2-5-2021 losing voice, all symptoms are reported to be intermittent Pfizer LOT # EL3246
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| 66 | 2021-02-10 | decreased appetite | malaise, body aches, fatigue, poor appetite; |
| 66 | 2021-02-10 | nausea |
This is a spontaneous report received from a contactable consumer (the patient). A 66-year-old femal...
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This is a spontaneous report received from a contactable consumer (the patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in the left arm on 29Jan2021 11:45 (at the age of 66-years-old) as a single dose for COVID-19 immunization. The patient's medical history included high cholesterol, and allergies to medications, food, or other products (unspecified). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Jan2021 12:15, the first 8 hours, the patient experienced nausea, dizziness, and slight headache. The patient did not receive any treatment for the events. The clinical outcome of nausea, dizziness, and slight headache was recovered on 29Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 66 | 2021-02-10 | nausea |
Injection site pain, Tiredness, Muscle pain in L arm, injection site swelling, Nausea, feeling unwel...
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Injection site pain, Tiredness, Muscle pain in L arm, injection site swelling, Nausea, feeling unwell, weakness, brain fog, lasted 40 hours.
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| 66 | 2021-02-10 | nausea | Fever 103 Body aches Uncontrollable shaking and chills Headache Nausea |
| 66 | 2021-02-10 | nausea |
3 hours after severe flu symptoms for 36 hours then severe headache, chills, nausea, malaise , for 8...
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3 hours after severe flu symptoms for 36 hours then severe headache, chills, nausea, malaise , for 8 days after
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| 66 | 2021-02-10 | nausea |
Ringing in head to the point of distraction and mild confusion , body aches, headache (worse than us...
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Ringing in head to the point of distraction and mild confusion , body aches, headache (worse than usual), dizziness and some queasiness. Fluctuates very bad for 6-12 hours, then slightly better for a few hours, then pattern repeats. Unusual fatigue occasionally but not too severe.
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| 66 | 2021-02-14 | retching, vomiting, nausea |
No reaction to first dose. However, 12 hours after receiving the second dose, I experienced the foll...
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No reaction to first dose. However, 12 hours after receiving the second dose, I experienced the following reactions, which lasted about 12 hours. Projectile vomiting and dry heaves Nausea Muscle aches, cramps, and spasms Chills Fever Sweats Headache in upper shoulders, neck, and back of head (intense)
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| 66 | 2021-02-15 | nausea, vomiting |
Pt. reported having GI symptoms such as nausea and vomiting for 2 days that started on 01/22/21. She...
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Pt. reported having GI symptoms such as nausea and vomiting for 2 days that started on 01/22/21. She also had reported taking a pain medication on an empty stomach prior to having GI symptoms.
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| 66 | 2021-02-15 | nausea |
Came over me quickly - short of breath at first due to surprise, anxious, achy, fever, chills, tire...
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Came over me quickly - short of breath at first due to surprise, anxious, achy, fever, chills, tired and sleepy. Nausea, weak, headache, feeling unwell. Took a valium to calm down. Felt better around 10 pm on 2/14 but lasted through 2/15. Woke up on 2/16 with my bed soaking wet.
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| 66 | 2021-02-16 | difficulty swallowing |
Patient received vaccine on 2/17/21 at approx. 1105, began noticing adverse symptoms at approx. 1115...
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Patient received vaccine on 2/17/21 at approx. 1105, began noticing adverse symptoms at approx. 1115. Patient reports symptoms are similar but slightly worse than what she experienced with 1st dose. Patient reports throat tightness, lip and tongue tingling, and having slight trouble swallowing. Patient reports she did see her physician prior to receiving 2nd dose and was recommended to take PO Benadryl prior to 2nd dose, which patient did. Patient was closely monitored for an additional 15 minutes (approx. 45 mins. in total). While patient was waiting she also took another PO Benadryl which was her own medication. Paramedic was also on site and monitoring patient. Patient reported her symptoms were beginning to resolve and she felt well enough to go home. Patient refused to be assessed fully in the ER and went home on her own. Advised if she notices any worsening to symptoms to seek emergency care, patient verbalized understanding.
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| 66 | 2021-02-16 | gastrointestinal pain, diarrhea |
I started with diarrhea a few days after I received my second dose of the vaccine. It has got worse...
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I started with diarrhea a few days after I received my second dose of the vaccine. It has got worse over the course of a week. I took immodium and peto bismol with some relief. I also have pains in my intestines. The pains only started in the last couple of days. I have a Dr. Appt today 2/17/21
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| 66 | 2021-02-16 | vomiting, nausea |
Patient began to feel flushed, hot. No nausea or vomiting. No shortness of breath or light headed ...
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Patient began to feel flushed, hot. No nausea or vomiting. No shortness of breath or light headed ness. O2 sat 100%, resp 18, BP 140/76, heart rate 67. Symptoms resolved and patient discharged from clinic
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| 66 | 2021-02-17 | vomiting | Enlarged or inflamed heart, lungs full of fluid, myocarditis, vomiting, dehydration |
| 66 | 2021-02-18 | nausea, vomiting |
First 24 hours: Chills, fever, vomiting, unable to keep anything down (even water) for the entire d...
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First 24 hours: Chills, fever, vomiting, unable to keep anything down (even water) for the entire day after the vaccine was given, body aches Second 24 hours: Chills, nausea, fever, body aches Third 24 hours: fatigue, some nausea, occasional chills, body aches Fourth 24 hours: fatigue Finally ALL better!
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| 66 | 2021-02-18 | nausea | Flushing, dizziness, nausea, headache, weird taste in the mouth. muscle ache. |
| 66 | 2021-02-19 | nausea, diarrhea, vomiting |
Nausea, vomiting, chills, diarrhea, myalgias. Insomnia during the 3 hours that nausea , vomiting and...
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Nausea, vomiting, chills, diarrhea, myalgias. Insomnia during the 3 hours that nausea , vomiting and diarrhea were occurring. Those symptoms now resolved but myalgias persist.
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| 66 | 2021-02-19 | vomiting |
Headache - lasted 24 hours Fever (100) - lasted 24 hours Swollen lymph node (under left arm) - laste...
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Headache - lasted 24 hours Fever (100) - lasted 24 hours Swollen lymph node (under left arm) - lasted 12 hours Vomiting - lasted 2 hours
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| 66 | 2021-02-21 | nausea, abdominal pain |
Nauseous, abdominal pain centered at the diaphragm. This is the same reaction I get with the erthry...
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Nauseous, abdominal pain centered at the diaphragm. This is the same reaction I get with the erthrymiacin and vibramiacin but it was much milder. Also light headed.
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| 66 | 2021-02-21 | vomiting |
Resident received the 2nd dose of the Covid vaccine approximately around 1105 by pharmacy through th...
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Resident received the 2nd dose of the Covid vaccine approximately around 1105 by pharmacy through the pharmacy LTC partnership vaccination program. Resident had no adverse effects until around 8:00 pm she began complaining of body aches, and chills, Tylenol was given at this time. Around 9:30pm resident was sleeping in bed. Around 12:00 am the CNA called nurse into room to assess resident as the resident stated she did not feel good. Temperature at that time was 102.2, and vomiting. RN came to assess @ 1220 am She was noted to be vomiting, diaphoretic, pale and having trouble breathing. Temp was 97.3 after vomting, Pulse 53, Resp 20, o2 sats were 40-45%, unable to obtain Blood pressure, Applied 5 L of oxygen at this time and had LPN call 911 immediately. Resident was repsonsive and able to follow staff members instructions but was only answering yes or no simple questions at the time time of assessment. Paramedics arrived at 0040 and resident was sent to Hospital. @ 0130 ER nurse called to nursing facility to notify resident had coded in the ER and passed away @ 0110.
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| 66 | 2021-02-22 | diarrhea, vomiting |
Headache in about 20 minutes after Vaccination. Next day had headache and diarrhea and by 3rd day ha...
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Headache in about 20 minutes after Vaccination. Next day had headache and diarrhea and by 3rd day has vomiting, chill and weakness which lasted 6 days
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| 66 | 2021-02-22 | nausea |
About 8 hrs after shot my mind started feeling foggy and heavy head, i got nauseous and achy joints ...
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About 8 hrs after shot my mind started feeling foggy and heavy head, i got nauseous and achy joints and having breathing problems. i was just sic. or like i had the flu or covid again. went on through the night. was up all night. my arm was just killing me. The next morning i was full on sick. the nausea was intense my temp throughout day was 99.6 and 99.9 . out of breath. That night i went to bed and woke up at midnight and was drenched my hair was soaked Got up at showered. at the 3:30 woke up again totally drenched. yesterday i woke up and 6:00 am i was feeling better but still trouble breathing but everything else was gone. I was tired still. About 10:30 yesterday Everything was fine. I do still have a little trouble breathing but not as bad.
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| 66 | 2021-02-22 | nausea |
She received her 2nd shot on 2/20/2021. Within minutes she noticed that she could not see, due to l...
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She received her 2nd shot on 2/20/2021. Within minutes she noticed that she could not see, due to localized swelling around her eyes. She began to feel itchy and her tongue felt swollen. She was taken to ED and was given Benadryl and Solu-Medrol, her symptoms continued and she was administered epinephrine about an hour later which immediately cleared up her symptoms. She has some residual generalized itching and has been taking Benadryl 50 mg every 6 hours until 9:00 p.m. yesterday. She also takes Zyrtec 10 mg daily starting yesterday. She denies having any dizziness or lightheadedness, hives urticaria, nasal congestion, weepy eyes, diarrhea or abdominal cramping. She does endorse nausea and was administered Phenergan in the emergency department. She also endorses that her eyes felt itchy. She also endorses that she was able to swallow. Takes celebrex but paused this prior to the vaccine to prevent possible anti-inflammatory interrupting vaccine efficacy. Her ED record is available for review. Exam findings endorse she is tolerating secretions, speaking in full sentences and her tongue was not enlarge. No labs were drawn during her visit. She denies historical reactions to vaccines. She does get itching with some medications. Historical angioedema/urticaria post pistachio and bran muffin were singular events and have not recurred. She had a normal tryptase in 2014
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| 66 | 2021-02-23 | vomiting |
Was diagnosed WITH Covid first symptom on 2/18/2021. Day 1: felt slight fever; Day 2: Extreme headac...
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Was diagnosed WITH Covid first symptom on 2/18/2021. Day 1: felt slight fever; Day 2: Extreme headache (which I never get) low grade fever; Day 3:Hives and itche sin addition to dry cough; Day 4 - Hives deep red, full torso and back, top of legs and pubic areas. Deep and extreme.Chills Steady, Night Hard vomiting, Hives, Soaking Night sweats (never had before), Temp 101.5. Day 5 Morning - rapid test negative, fever 99.9. Started Ibuprofen Day 6 - Hives same - extremely dark and red. itchy. # day swab test was POSITIVE. Put on Prednisone. Day 7 - Fever normal, Hives going down but still ugly. Not sure whether this was really an adverse event as it was a positive test result AFTER the vaccine. I am an allergig person whose eosinophils report for duty quickly and obviously too much! I will assume that they were the result of the virus and NOT the drug as the drug does not have an active virus included. Your call.
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| 66 | 2021-02-24 | abdominal pain upper, gastrointestinal pain, diarrhea |
2 weeks after the 2nsd dose (February 15), I started experiencing stomach and intestinal pain. At t...
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2 weeks after the 2nsd dose (February 15), I started experiencing stomach and intestinal pain. At time this wakes me up from a sound sleep. I have had some diarrhea with this. I started taking Probiotics on February 19th which has helped with the diarrhea but the stomach pain is still very real. Ibuprofen will help for about 2 hours but then it comes back.
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| 66 | 2021-02-24 | diarrhea, vomiting | Dizziness, vomiting, diarrhea, headache, chills. |
| 66 | 2021-02-24 | nausea | Nausea, flushed, feeling anxious, evaluated by EMS-cleared |
| 66 | 2021-02-24 | stomatitis |
mouth sores; Numbness of left arm, shoulder and left side of face; some tongue swelling.; This is a...
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mouth sores; Numbness of left arm, shoulder and left side of face; some tongue swelling.; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration at the age of 66 years, on 10Feb2021 09:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing, drug hypersensitivity (sulfa drugs) from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient previously took tetracyclines and experienced drug hypersensitivity, pneumovax vaccin and experienced drug hypersensitivity. On 10Feb2021, the patient experienced numbness of left arm, shoulder and left side of face and some tongue swelling. The patient applied ice for several hours. After 5 hours or so, the face and tongue were back to normal. The following day (11Feb2021), they noticed mouth sores. The patient used salt water rinse to help. The patient asked if she should be avoiding the 2nd dose scheduled in 18 days as a result of this reaction. Therapeutic measures were taken as a result of numbness of left arm, shoulder and left side of face (hypoaesthesia), some tongue swelling. (swollen tongue), mouth sores (stomatitis). The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 66 | 2021-02-25 | nausea | Vertigo and nausea |
| 66 | 2021-02-26 | diarrhea | Headache Diarrhea |
| 66 | 2021-02-26 | nausea | Nausea Achy Chills Headache Sore arm at site Fatigue |
| 66 | 2021-02-27 | decreased appetite |
Spike in blood pressure occurred 3-4 hours after injection (controlled by additional medication) and...
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Spike in blood pressure occurred 3-4 hours after injection (controlled by additional medication) and again the day after. Injection site became red and itchy within an hour of injection; redness has spread down the arm and continues to itch on day 3. This did not occur with first jab. Loss of appetite, fatigue, and brain fog, the day of and next day.
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| 66 | 2021-02-28 | diarrhea |
Urine had a reddish dye not quite blood and loose bowel movement the next day following the first do...
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Urine had a reddish dye not quite blood and loose bowel movement the next day following the first dose. After eliminating the waste my urine and bowles was back to the normal. It was quite scary.
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| 66 | 2021-02-28 | diarrhea |
Took benadryl for injection site inflammation; Swelling; Itching; heat at injection site occurring o...
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Took benadryl for injection site inflammation; Swelling; Itching; heat at injection site occurring over the week post-injection; Knot; diarrhea which is like I had when I had Covid last fall.; This is a spontaneous report from a non-contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL3249), on 01Feb2021 at 15:00 (at the age of 66-years-old) at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at Doctor's office/urgent care. No other vaccine was given within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Other medical history included irritable bowel syndrome (IBS), and high blood pressure. Concomitant medications included linsinopril, estradiol, naproxen sodium (ALEVE), tocopherol (VIT. E), colecalciferol (VITAMIN D), multivitamin. On 03Feb2021 the patient experienced swelling, itching, knot, heat at injection site occurring over the week post-injection, injection site inflammation, as well as diarrhea which is like she had when had Covid last fall. The events resulted in emergency room/department or urgent care. As treatment received it was reported the patient took Benadryl for injection site inflammation. The events were resolving. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
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| 66 | 2021-02-28 | diarrhea |
Started with extreme exhaustion 1 hour after vaccination, very loose stools X3 days, extreme joint p...
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Started with extreme exhaustion 1 hour after vaccination, very loose stools X3 days, extreme joint pain 1 1/2weeks- pain continues until present, headache for 12hours with headache off & on continues, cough x 5 days
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| 66 | 2021-02-28 | difficulty swallowing |
2/25/2021 9:30am minor pain at injection site upper left arm 2/26/2021 1:30pm dull headache, backsid...
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2/25/2021 9:30am minor pain at injection site upper left arm 2/26/2021 1:30pm dull headache, backside of head and very tired 2/26/2021 5:30pm minor tongue swelling, minor throat and nasal passage constriction 2/27/2021 9:30am increased tongue swelling, increased throat and nasal passage constriction, minor difficulty swallowing, minor facial swelling 2/27/2021 6:30pm treatment at ER/Urgent Care with oral Prednisone tongue swelling started to decrease, released with Rx for Benadryl, Pepcid, Prednisone and EpiPen 2/27/2021 8:00pm started Benadryl + Pepcid. Tongue swelling decreased more, throat and nasal constriction starts to alleviate 3/1/2021 9:00am facial swelling continues with added redness to left side face and spot under right eye socket 3/1/2021 11:20am family doctor visit
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| 66 | 2021-02-28 | nausea, diarrhea |
tenderness under both armpits; Headache; Nausea; Diarrhea; felt like she had a fever that would come...
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tenderness under both armpits; Headache; Nausea; Diarrhea; felt like she had a fever that would come and go; felt like she had Covid again; She got hot; chills; really sick last night; This is a spontaneous report from a contactable consumer, the patient. A 66-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL9261), via an unspecified route of administration in the left arm on 27Jan2021 at 11:10 (at the age of 66-years-old) as a single dose for covid-19 immunisation . Medical history included diabetes mellitus from 1995 and ongoing , ongoing hypertension , covid-19 from an unknown date and unknown if ongoing (Had Covid at Christmas). The facility in which the vaccine was received was a Workplace Clinic There were no concomitant medications. No other vaccines were given within 4 weeks. On 27Jan2021 The patient reported she was sick last night, tenderness under her arm pits, headache, nausea, diarrhea and she felt like she had a fever that would come and go. She got hot and then had chills. She felt like she had Covid again. Treatment included Zofran and it helped with the nausea. There was No physician office visit and No emergency room visit as a result of the events The clinical outcome of the events Nausea, diarrhea, was recovered on 27Jan2021, tenderness under both armpits recovered on 28Jan2021, Headache non recovered, Fever was recovering, while felt like she had Covid again, Feeling hot Chills and Sick unknown.
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| 66 | 2021-02-28 | nausea, vomiting |
Fever, chills, nausea, vomiting, migraine aura, headache - onset 20 hours after dose. Took Tylenol a...
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Fever, chills, nausea, vomiting, migraine aura, headache - onset 20 hours after dose. Took Tylenol and fever reduced from 99.9 to 98.6. Head ache persisted for 12 hours following onset. Remainder of side effects resolved within 6 hours of onset.
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| 66 | 2021-02-28 | retching |
Headache in the back of my neck radiating up into the back of my head; Headache in the back of my ne...
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Headache in the back of my neck radiating up into the back of my head; Headache in the back of my neck radiating up into the back of my head; Projectile vomiting; Dry heaves; Fever; Chills; Muscle spasms; Swollen glands; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL8982; Expiration date was not reported) on 26Jan2021 (10:15) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included allergy-induced asthma; Celiac disease; bradycardia; was a pacemaker user (for bradycardia); sulpha allergy; and latex allergy. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), alprazolam, lisinopril, montelukast, and other unspecified medications. The patient previously took cephalexine, and had allergy. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140; Expiration date was not reported) on the left arm on 07Jan2021 (when the patient was 66 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 26Jan2021 (23:00), the patient had headache in the back of the neck, radiating up into the back of the head; projectile vomiting; dry heaves; fever; chills; muscle spasms; and swollen glands. The patient did not receive any treatment for the reported events. The outcome of the events, 'headache in the back of the neck, radiating up into the back of the head', 'projectile vomiting', 'dry heaves', 'fever', 'chills', 'muscle spasms' and 'swollen glands', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination.
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| 66 | 2021-02-28 | retching |
Before I left the hospital parking lot I could taste the drug in my moth. By the time I got home ...
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Before I left the hospital parking lot I could taste the drug in my moth. By the time I got home I had the dry heaves. I was also alternating hot and cold. This went from about 7 pm to 8 AM the next day. That day I had a head ache which I normally do not have.
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| 66 | 2021-03-01 | nausea, diarrhea | Nausea, diarrhea, body aches, hypotension, headache |
| 66 | 2021-03-01 | nausea |
My arm was very sore the evening of vaccine and the next day. Later the day after I had a headache ...
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My arm was very sore the evening of vaccine and the next day. Later the day after I had a headache and felt nauseous. I keep getting headaches on and off. Sometimes dizzy. The nausea is almost all the time. It has not improved. It has been one week.
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| 66 | 2021-03-01 | nausea |
Pfizer-BioNTech COVID-19 Vaccine EUA Started with some headache 30 minutes after the vaccine and the...
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Pfizer-BioNTech COVID-19 Vaccine EUA Started with some headache 30 minutes after the vaccine and the following day in the afternoon the fever started (high 40/41C), nausea and intense body aches. These symptoms lasted until Monday (2 full days). Today is the 3rd day, and still with body aches a little nausea, very painful and warm arm but no fever. This was the first dose but the patient had Covid in March of 2020 ( at the time all the symptoms mentioned above were present with the addition of having lost taste and having some hallucinations. No problem breathing. Just letting you know for the purpose of statistics.
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| 66 | 2021-03-02 | abdominal distension |
About 3 minutes after COVID-19 Injection, patient started to have numbness in lips, tongue felt swol...
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About 3 minutes after COVID-19 Injection, patient started to have numbness in lips, tongue felt swollen, chest and abdomen tingling and tightness. Lasted about 5 minutes and then resolved.
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| 66 | 2021-03-02 | diarrhea |
migraine with flashes of light in left eye; migraine with flashes of light in left eye; gets IBS stu...
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migraine with flashes of light in left eye; migraine with flashes of light in left eye; gets IBS stuff; has had diarrhea; diarrhea, had a mild version of the diarrhea that seemed to get worse after the vaccine and still ongoing; vessels in hands really dilated and dark blue; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL9264), via an unspecified route of administration (arm left) on 30Jan2021 14:00 at SINGLE DOSE for to have some protection against COVID, at 66 years old. Medical history included connective tissue disorder and anti-cardiac lipid antibody problem; she is prone to blood clots from 2001. At that time, she was sent to the hospital and no one could figure out what it was. She was seeing the Rheumatologist and another person, and they knew something was going on and was given Prednisone (from 2001) because her tissues in the joints were swelling and she had trouble with speech. Patient also reported this as some weird connective tissue disorders already and some anti-cardiac lipid antibody problem. It was really weird and had not changed a bit since so she was kind of checking to see if anyone has reported anything like this. She reported that with this weird antibody problem, she is more prone to blood clots and has to be careful with medications with her blood she knows that some breast cancer medicines can do that. She stated this immune thing was never diagnosed. She also had migraine with globes of flashes of light, left eye (does not typically get migraines and has only had 1 in her life and she saw globes of lights in both eyes and had to go to the emergency room and was told it was an ocular migraine and this was also only in the left eye. This was long ago) from an unspecified date. Concomitant medication included low dose steroid (unspecified). The patient previously received flu vaccine on Sep2020 (AE none). No other vaccines were administered on the same day. On 30Jan2021, the patient experienced vessels in hands were really dilated and dark blue 5 hours after vaccination. On 30Jan2021, the patient also experienced IBS stuff and has had diarrhea the last couple of days after getting the COVID vaccine. She took Pepto Bismol to help and had a mild version of the diarrhea that seemed to get worse after the vaccine and still ongoing. On 01Feb2021, the patient experienced migraine with flashes of light in left eye. It was further described as having a weird migraine with flashes of light in the left eye and she got the shot in her left arm and not sure if that makes any difference. She does not typically get migraines and has only had 1 in her life. The migraines started in the morning and lasted about an hour (as reported) and now they are gone and hopes they stay gone (reported as recovering). She wanted to know if she can take TYLENOL or ibuprofen for vaccine. She heard about people getting symptoms after the second dose not the first dose. Events did not require visits to the emergency room or physician office, but stated that if her vision become worse, she would go to the eye infirmary close by. The outcome of the events diarrhea and vessels in hands really dilated and dark blue, gets IBS stuff was not recovered. Outcome of the events migraine with flashes of light in left eye was reported as recovering.
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| 66 | 2021-03-02 | flatulence, abdominal distension |
terrible gas and bloating - starting 12 hours after injection and lasting 1 day, rapid and irregula...
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terrible gas and bloating - starting 12 hours after injection and lasting 1 day, rapid and irregular heart rhythm - beginning 40 hours after injection - lasting 6 hours, extreme tiredness - day 7 & 8, lower back and hip pain - day 7 and currently day 10, general feeling unwell - most days
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| 66 | 2021-03-02 | nausea |
Fever 101, aches, awful headaches, nausea, threw up 5 times, very tired, fatigue. Lasted 4 days. H...
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Fever 101, aches, awful headaches, nausea, threw up 5 times, very tired, fatigue. Lasted 4 days. Headaches have not gone away since my first symptoms of Covid on December 24, 2020
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| 66 | 2021-03-03 | decreased appetite, nausea |
DIZZINESS, DISORIENTATION, UNSTEADY GAIT, SEVERE HEADACHE, NAUSEA WITHIN 10 MINUTES OF VACCINE; THES...
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DIZZINESS, DISORIENTATION, UNSTEADY GAIT, SEVERE HEADACHE, NAUSEA WITHIN 10 MINUTES OF VACCINE; THESE SIDE EFFECTS CONTINUED ALONG WITH EXTREME FATIGUE, NO APPETITE, LOSS OF 6 LBS IN 6 DAYS, WEAKNESS. SYMPTOMS STILL PERSISTING ON DAY 8.
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| 66 | 2021-03-03 | nausea, vomiting |
Nausea; vomiting; This is a spontaneous report from a contactable consumer. A 66-year-old female pa...
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Nausea; vomiting; This is a spontaneous report from a contactable consumer. A 66-year-old female patient, who was also 66-year-old at the time of vaccination, received first dose of bnt162b2 (BNT162B2), lot number not reported, via an unspecified route of administration from 01Feb2021 as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 02Feb2021 02:00, patient experienced nausea and vomiting. The outcome of the events was recovered. The patient is not pregnant at the time of vaccination. No treatment was given for the events. The patient did not have COVID-19 prior vaccination. The patient was not tested for COVID-19 post vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 66 | 2021-03-03 | nausea, vomiting |
She had syncope, nausea, vomiting on 2/10/21, 4 days after vaccine. She went to ED that day. She saw...
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She had syncope, nausea, vomiting on 2/10/21, 4 days after vaccine. She went to ED that day. She saw me today (3/4/21) and has had recurrent nausea, vomiting and dizziness but no further syncope.
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| 66 | 2021-03-03 | nausea |
SOB, heart arrhythmia, slight nausea. Seen by EMT on site. BP 180/90, Afib on EKG, (None seen on 1...
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SOB, heart arrhythmia, slight nausea. Seen by EMT on site. BP 180/90, Afib on EKG, (None seen on 12 lead), lungs clear, O2 sat taken (no comment from EMT), Glucose checked, lungs clear.
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| 66 | 2021-03-03 | vomiting, nausea |
break a blood vessel in her left eye; felt sick to her stomach; threw up; Half of the white in her l...
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break a blood vessel in her left eye; felt sick to her stomach; threw up; Half of the white in her left eye turned solid red; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date were not provided), via an unspecified route of administration on right arm, at 66-year-old (not pregnant at vaccination), on 15Feb2021 at 15:00 as a single dose for COVID-19 immunization. The vaccine was received in hospital. Medical history included ongoing chronic back pain, high blood pressure. No known allergies were reported. The patient did not experience COVID-19 prior vaccination. Concomitant medications included hydrocodone bitartrate, paracetamol (NORCO), fluoxetine hydrochloride (PROZAC), triamterene, baclofen. No other vaccine was received in four weeks. On 21Feb2012 at 12:00 (reported as 6 days later) the patient felt sick to her stomach and threw up which caused her to break a blood vessel in her left eye. Half of the white in her left eye turned solid red. Later she felt fine and was able to eat dinner. The patient did not have COVID-19 test post vaccination. The patient did not receive treatment for the events. The outcome of the events was recovering. Information on the batch/lot number has been requested.
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| 66 | 2021-03-04 | difficulty swallowing, nausea |
Pt c/o nausea reported to EMT AT 1507. EMT reported to RN's on site. Pt offered adult dose of diphen...
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Pt c/o nausea reported to EMT AT 1507. EMT reported to RN's on site. Pt offered adult dose of diphenhydramine. Pt denied diphenhydramine. Pt denied difficulty swallowing, unlabored breathing, denies throat pain, denies any chronic illnesses. Pt advised to wait an extra 15 minutes for further observation. Pt symptoms subsided. Pt left vaccination site at 1523 with a steady gait.
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| 66 | 2021-03-04 | nausea |
Headache, chills, body aches, slight intermittent nausea. Alternated Motrin and Tylenol Q3 hours. Be...
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Headache, chills, body aches, slight intermittent nausea. Alternated Motrin and Tylenol Q3 hours. Began medication at 1145am . Improving as day progresses. ( 2 doses Motrin, 1 dose Tylenol) Currently slight headache and body aches, but much improved.
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| 66 | 2021-03-04 | vomiting, diarrhea, nausea | Nausea, Vomitting, Diarrhea, Headache |
| 66 | 2021-03-07 | abdominal pain upper |
24 hours after the injection I started to flush on my face neck and ears. I itched all over especial...
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24 hours after the injection I started to flush on my face neck and ears. I itched all over especially my eyes and throat. I was very agitated and shaking. I took an allergy Med at 2 pm and again at 7pm. The 2 Nd dose calmed me enough to get to sleep around 11pm. I was very close to going to the ER. In the morning I had a stomach ache like I have experienced before with and allergic reaction. Cramping pain , it lasted all day there was no nausea. The 3 day a headache that seemed appropriate for the vaccine.
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| 66 | 2021-03-07 | difficulty swallowing |
9:25 am Returned to facility light headed, dry mouth and mouth tingling. Blood pressure 170/88 ,puls...
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9:25 am Returned to facility light headed, dry mouth and mouth tingling. Blood pressure 170/88 ,pulse70 ,pso2 99%. Respirations even and unlabored. Skin pink, warm and dry. Sat a while reported mouth tingling better. 9:44 reported dizziness increased took her pepcid and atavert as she said her allergist suggested. 9:48 Client reported difficulty swallowing taken to the ER
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| 66 | 2021-03-07 | nausea, decreased appetite |
Nausea immediately with injection, injection site pain, tiredness, headache, body aches, dizziness, ...
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Nausea immediately with injection, injection site pain, tiredness, headache, body aches, dizziness, blurred vision, poor appetite, unable to taste food, feeling unwell. day later rash on chest, next day heart racing, breathing shallow and fast, chest hurting. roads were iced over, to unsafe to drive.
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| 66 | 2021-03-07 | nausea |
In patient reported "nausea and hot face". EMT evaluated. Pt's symtoms resolved after 23 minutes. No...
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In patient reported "nausea and hot face". EMT evaluated. Pt's symtoms resolved after 23 minutes. No emesis, no facial flushing, no respiratory distress. Pt was released at 3:09 pm. RN
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| 66 | 2021-03-07 | vomiting |
Pfizer shot on Sunday am - my father noticed my mother c/o not feeling well and unable to explain w...
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Pfizer shot on Sunday am - my father noticed my mother c/o not feeling well and unable to explain why she didn't feel well. She woke up feeling well and then quickly became disoriented and vomited. She was then unable to walk or communicate appropriately. Emergency services was called and she was transported to Emergency room. She was diagnosed with a posterior brain CVA and was treated with tpa and now remains hospitalized in the ICU with expressive aphasia and vision loss.
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| 66 | 2021-03-08 | abdominal discomfort | Fever , My bones hurt legs and arms low part of my back My head hurt so bad sick to my stomach |
| 66 | 2021-03-08 | abdominal discomfort |
Client reported abdominal discomfort 10 minutes after vaccination. Stated, "I think that my sugar i...
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Client reported abdominal discomfort 10 minutes after vaccination. Stated, "I think that my sugar is low." Blood sugar 114. Complained of feeling hot and cold. Exited car and spat out clear secretions. Client observed for 30 minutes. Reported that abdominal discomfort felt "A little better." Declined further observation. Driven off site by her son.
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| 66 | 2021-03-08 | diarrhea |
Severe explosive diarrhea cannot control. I have been taking up to ^ imodiums a day gas ex and char...
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Severe explosive diarrhea cannot control. I have been taking up to ^ imodiums a day gas ex and charcoal tablets.
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| 66 | 2021-03-08 | nausea, decreased appetite |
Chills, severe fatigue, weakness, dizziness, unstable on feet , nausea , GUM SWELLING, roof of mouth...
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Chills, severe fatigue, weakness, dizziness, unstable on feet , nausea , GUM SWELLING, roof of mouth burning and pain Tingling in hands and feet, loss of appetite.
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| 66 | 2021-03-08 | nausea | Chills, fever, muscle and body aches, headache, naseua |
| 66 | 2021-03-09 | abdominal discomfort | Tired achy upset stomach |
| 66 | 2021-03-09 | diarrhea, nausea, gastrointestinal disorder |
having lots of Gastrointestinal issues/have gastrointestinal stuff going on; up in the middle of the...
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having lots of Gastrointestinal issues/have gastrointestinal stuff going on; up in the middle of the night; body aches/achy; chills (no fever); nausea; got the sore arm; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318 (not clarified further)), via an unspecified route of administration on 03Feb2021 at single dose for COVID-19 immunisation and loratadine (CLARITIN), via an unspecified route of administration from 03Feb2021 at an unspecified dose for unspecified indication. Medical history included ongoing High cholesterol and Sleep disorder, both from unknown date. Concomitant medication included alprazolam (XANAX), calcium (CALCIUM), cyanocobalamin (VITAMIN B12), Multivitamin, taking a statin to prevent high cholesterol and L-methylfolate, stated it is like a folic acid drug. Because the patient really can't take anti-depressant she reacted to them all (Unspecified Medications), so that worked for her and helped her to keep up her spirit. The patient reported her side effects. She didn't want to interfere with anything but she was having lots of Gastrointestinal issues which were inconvenient. She was up in the middle of the night, happened not within 48 hour after the first dose of the Pfizer vaccine but around 60 hours after the vaccine, early this morning (06Feb2021) like around 2 am. The patient was having a reaction after the vaccine but they seemed to be like delayed reactions. Not anything with breathing, she had gastrointestinal stuff going on. The patient had chills, no fever, body aches and she was really going to the bathroom nonstop in the night. It seemed to have been like 2 days after she got the shot like they were worst yesterday (05Feb2021). And she experienced achy, chills, nausea, diarrhea and sore arm in Feb2021. She would like to take TYLENOL and IMODIUM and she didn't know what she could take because she didn't want anything to interfere with that as she had been reading a lot. The patient wanted information on IMODIUM to prevent diarrhea, TYLENOL for body aches, chills (no fever), and FLONASE for sinus. The patient did not receive any treatment for the events. The patient actually didn't even take, that morning that day when she was getting the shot, she called the pharmacist to see if she could spray her nose with the FLONASE for sinus and he told her that he didn't think it was a good idea and that maybe she should just take CLARITIN, so she did. But she took CLARITIN that morning (03Feb2021) and she was hoping that didn't interfere. She was just nervous about it as she didn't want that to interfere with the work that it was. The patient was still suffering, less, like she didn't have the diarrhea anymore. She still had a little achy. She did get the sore arm but only for one day, so it wasn't so bad. The action taken in response to the events for loratadine was unknown. The outcome of event diarrhea and got the sore arm was recovered on an unspecified date in Feb2021, of event achy was recovering, of other events was unknown. Information on the lot/batch number has been requested.
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| 66 | 2021-03-09 | nausea |
injection site pain, redness, and swelling; injection site pain, redness, and swelling; injection si...
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injection site pain, redness, and swelling; injection site pain, redness, and swelling; injection site pain, redness, and swelling; headache; chills; muscle and joint pain; muscle and joint pain; nausea; dizziness; weakness; This is a spontaneous report from a contactable consumer (the patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EM9809), via an unspecified route of administration in the left arm on 06Feb2021 13:30 (at the age of 66-years-old) as a single dose for COVID-19 immunization. The patient's medical history included slightly elevated blood pressure, not taking medication, and COVID prior to vaccination, on an unspecified date. The patient had no known allergies. The patient was not pregnant at the time of vaccination. Concomitant medications included paracetamol (TYLENOL) and vitamin supplements. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 06Feb2021 16:00, the patient experienced injection site pain, redness, and swelling; headache, chills, muscle and joint pain, nausea, dizziness and weakness. No treatment was received for the events. The clinical outcome of the events was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 66 | 2021-03-09 | nausea |
Progress Notes COVID VACCINE CLINIC 3/3/2021 Patient is a 66 y.o. female who was seen at Vaccine...
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Progress Notes COVID VACCINE CLINIC 3/3/2021 Patient is a 66 y.o. female who was seen at Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience feeling flushed/nausea. She denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , hypotension, rapid progression of symptoms, respiratory distress and vomiting. She reports she took her coreg 25 mg dose torsemide 20 mg doses this am. She did eat toast and yogurt around 7 this am. Past Medical History: Diagnosis Date ? Biventricular ICD (Medtronic) implanted on 8/19/14 8/20/2014 ? Depression ? Depressive disorder, not elsewhere classified ? GERD (gastroesophageal reflux disease) ? Heart failure (HCC) LVEF 40-45% by ECHO 1/2012. ECHO 11/13 LVEF 50-55%. LVEF 37% by nuclear stress test 2/20.14. ECHO 4/2014 LVEF 30-35%. LVEF by echo from 3/2017 LVEF 50-55%. ? hospitalization Admit on: 20111020; Diagnosis: Acute respiratory failure, acute on chronic systolic and diastolic heart failure; at: Stormont-Vail HealthCare; ? Hypertension ? LBBB (left bundle branch block) ? Mitral regurgitation Moderate secondary to annular dilation ? NICM (nonischemic cardiomyopathy) (HCC) Cardiac cath from 10/2011 normal coronary arteries. Nuclear stress test 2/2014 no ischemia. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, ear pain, sore throat, eyes watering, eyes itching, eye redness, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, cysts, itching of skin, abdominal pain, blood in stool, muscle aches, joint pain, dizziness and headaches Previous Reactions: none Objective Vitals Vitals: 03/03/21 0920 03/03/21 0928 03/03/21 0937 03/03/21 1000 BP: 97/50 97/57 112/60 104/58 Pulse: 96 86 68 Resp: 18 16 14 Temp: 98.4 °F (36.9 °C) SpO2: 100% 100% 100% Blood Sugar 71 collected at 0922 Blood sugar 103 collected at 0945 Physical Exam Vitals and nursing note reviewed. Constitutional: General: She is not in acute distress. Appearance: She is not diaphoretic. Comments: Flushed. Negative for diaphoresis Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Coloration: Skin is pale. Findings: No rash. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Behavior is cooperative. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: water, snacks and reclined Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash) Greatly improved after water/snack/reclining. Pt observed for 45 minutes in the bay. She feels comfortable going home. Her blood pressure drop may be related to her taking two medications that affect her bp as mentioned above. She's improved with hydration and snack. Recommended that she rest, monitor her bp at home. If symptoms worsen or returns, recommend evaluation in ED. Otherwise follow up with pcp office. Pt wheeled out with RN and husband. Pt voices appreciation of her care today.
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| 66 | 2021-03-10 | decreased appetite |
Fever for 3 days. 101.2-101.6, chills, body aches, sore arm at injection Severe migraine type headac...
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Fever for 3 days. 101.2-101.6, chills, body aches, sore arm at injection Severe migraine type headache lasted for 4 days Severe exhaustion 4 days No appetite 4 days Day 5 just wiped out!
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| 66 | 2021-03-10 | decreased appetite |
As the vaccine was being injected I immediately had a strange taste in my mouth, like 'tin' or like ...
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As the vaccine was being injected I immediately had a strange taste in my mouth, like 'tin' or like being at the dentist. 4 hours later I drank some coffee and it had no taste. I quickly learned I could not taste or smell anything. This went on for 5 days. Very nauseated and my pain medicine I take was not holding 6 hrs. My body pain was magnified x10. I had a hard time staying awake and no appetite. My Dr. office said they had this reported to them from other patients. I don't know if I am to get the second vaccine as no one is getting back to me.
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| 66 | 2021-03-10 | diarrhea |
About 10 minutes after receiving the vaccine, my left arm started burning. This lasted maybe 15 min...
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About 10 minutes after receiving the vaccine, my left arm started burning. This lasted maybe 15 minutes. I did not have this with the first vaccine. Around 7pm I started to develop chills which over a few hours I started to have shaking from the chills. I also developed a headache, Temperature 101.1, muscle weakness, pain at insertion site and diarrhea. I used Tylenol and Advil. Around 0500 no longer experienced a temperature and chills had lessened. Continued on day two to have slight chills and headache along with weakness. Day 3 minimal weakness
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| 66 | 2021-03-10 | nausea |
pt states that she woke up w/ headache, nauseated, SOB, and pain in left arm. she says these sympt...
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pt states that she woke up w/ headache, nauseated, SOB, and pain in left arm. she says these symptoms come and goes in waves. pt went to urgent Care on 3/8/2021. Pt was ordered Chest X-Ray that came back normal. Rapid Covid Test w/ negative results. All vitals were good. Pt was prescribed an inhaler. Pt also went to her local pharmacy and took another Covid test on 3/10/2021 w/ pending results and then FU w/ PCP.
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| 66 | 2021-03-10 | vomiting, nausea | Nausea vomiting aches everywhere extreme headache dehydrated chills sweats |
| 66 | 2021-03-11 | abdominal discomfort | Fatigue, upset stomach, stuffy nose |
| 66 | 2021-03-11 | decreased appetite |
Pain left arm and all over body, muscle aches, felt feverish but didn't take temp, headache, lost ap...
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Pain left arm and all over body, muscle aches, felt feverish but didn't take temp, headache, lost appetite.
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| 66 | 2021-03-11 | nausea |
lost voice, sore throat, coughing, sneezing, dizzy, nauseated all within the two and half weeks sinc...
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lost voice, sore throat, coughing, sneezing, dizzy, nauseated all within the two and half weeks since I received it .
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| 66 | 2021-03-11 | nausea | Mild nausea over the course of the first day. Nothing after that. |
| 66 | 2021-03-12 | difficulty swallowing |
pt c/o SOB, throat swelling which progressed to difficulty swallowing. Epi IM given x1 then transfer...
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pt c/o SOB, throat swelling which progressed to difficulty swallowing. Epi IM given x1 then transferred to ED
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| 66 | 2021-03-12 | nausea | Chills, Fever, Fatigue, Aches, Headache, Nausea, Very Sore Arm at shot site, stuffy nose |
| 66 | 2021-03-12 | nausea |
Fever, chills, Migraine like headache, dizzy upon first arising from bed.,, Loud ringing in ear and ...
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Fever, chills, Migraine like headache, dizzy upon first arising from bed.,, Loud ringing in ear and extreme bright light, feeling of fainting, quick nauseous feeling.
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| 66 | 2021-03-13 | decreased appetite, abdominal discomfort, vomiting |
5-6 days after, my stomach felt pressure, like something pushing in. On the night of the 6th day, I...
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5-6 days after, my stomach felt pressure, like something pushing in. On the night of the 6th day, I wasn't interested in eating, the pressure/discomfort feeling was increasing and I was uncomfortable all over and unable to get to sleep. Around 2 or 3 am, I had an episode of violent vomiting, which did not serve to make me feel any better. From that point on, for the next 24 hours, I continued to feel sick, extremely tired, and ached all over. I couldn't get comfortable, didn't feel like eating or even drinking, and had no energy, even to not being able to sit up and watch TV. As the 7th day continued, I threw up mid-day, was able to sip my way through 2 glasses (water, tea), and eat a few crackers. I felt very dizzy when I walked. I checked my temperature twice and didn't seem to be running a fever, which surprised me. I didn't take any pain relievers, as I felt I would just throw them up. By evening, however, I was able to take 2 ibuprofen, take a hot shower, and slept pretty well that night. By the 8th day, the aches were pretty much gone and I was able to eat soft foods and get rehydrated. I felt a little weak, still tired, and wobbly, but was clearly over the worst of it. By the 9th day, I was back to normal.
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| 66 | 2021-03-13 | nausea |
Pfizer-BioNTech COVID-19 Vaccine EUA: five days after vaccination patient reports waking up with hea...
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Pfizer-BioNTech COVID-19 Vaccine EUA: five days after vaccination patient reports waking up with headaches starting the day after being vaccinated. Acetaminophen and NSAIDS provide relief. Also reports dizziness, nausea, and photophobia. Patients denies numbness, tingling, or difficulty with speech or word finding. On follow-up visit eleven days after vaccination patient reported an episode of shortness of breath with a dry cough and runny nose with chills that day but headache improving. Symptoms determined to be related to chronic sinus problems and allergies.
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| 66 | 2021-03-13 | nausea |
Second day: soreness at the site. Fatigue and nausea. Third, fourth and fifth day fatigue and head a...
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Second day: soreness at the site. Fatigue and nausea. Third, fourth and fifth day fatigue and head ache
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| 66 | 2021-03-14 | diarrhea |
Five days later. March 2, I had a bout of diahrrea for about 90 minutes I also have the expected one...
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Five days later. March 2, I had a bout of diahrrea for about 90 minutes I also have the expected ones: Headache, some temperature, tireness. Today, March 15,, I had the same problem also about 90 minutes.
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| 66 | 2021-03-14 | burping, flatulence, nausea | Nausea, cramping, gas, burping and flatulence. Duration: 2 hours |
| 66 | 2021-03-14 | nausea, diarrhea |
Felt like I had food poisoning. Intense diarrhea, intense cramps, nauseous (thought I was going to ...
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Felt like I had food poisoning. Intense diarrhea, intense cramps, nauseous (thought I was going to throw up), body temperature kept going up and down (cold one minute and hot the next minute) - Started at 10:00 p.m. and lasted close to an hour. After that, felt extremely light headed
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| 66 | 2021-03-14 | nausea |
Shortness of breath, chest pain, chills, fatigue, pain in back, nausea - Went to ER Feb 28, 2am - sy...
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Shortness of breath, chest pain, chills, fatigue, pain in back, nausea - Went to ER Feb 28, 2am - symptoms continue for another week.
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| 66 | 2021-03-14 | vomiting, burping, abdominal pain upper |
got my first dose at 12:45 pm on Friday the 12 th of March. At 12:30 am Saturday morning i started...
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got my first dose at 12:45 pm on Friday the 12 th of March. At 12:30 am Saturday morning i started throwing up. I threw up every hour for a total of 3 times. last time was 2:30 am. My stomach was gurgling and it hurt to press on it. and i kept belching. Had no energy. On Saturday was able to sleep 3 hours in my rocker until 2:15pm when i threw up again. Had no energy. Had chills the first day starting about 4 pm Friday after my shot. Called the emergency room to see if I could take antinausea pills I had . Talked to my doctor and he said I was allowed. It was ondansetron 4 mg. I took one at 3 pm and started feeling less weak.
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| 66 | 2021-03-14 | vomiting |
I was fine the day I received the shot, the next morning I woke up with a headache and arm pain. My ...
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I was fine the day I received the shot, the next morning I woke up with a headache and arm pain. My breathing started to get worst. I already was having problems since I had Covid in January into February. A week later I woke up and felt very sick, started throwing up all day into the night, had 101 fever and chills. That lasted about a day and a half. I still felt sick for the next two days. I continue using having breathing problems worst than before the shot. I am also very exhausted.
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| 66 | 2021-03-15 | abdominal distension |
muscle and nerve on both side of her face and the area along the back of both ears on the back head ...
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muscle and nerve on both side of her face and the area along the back of both ears on the back head are very uncomfortable; muscle and nerve on both side of her face and the area along the back of both ears on the back head are very uncomfortable; From thumb finger till middle figure of both hands are numb especially after getting up daily.; The nerve of both front elbows is uncomfortable a lot stronger (e.g. sensation of soreness and distention); Both gums are very soreness and distention; Both gums are very soreness and distention; Stuffy nose; night sweats; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration, at the age of 66-year-old, on 20Feb2021, single dose for COVID-19 immunization. Relevant medical history included diabetes. The patient had no known allergies. Patient is not pregnant. Concomitant medications included metformin, thiamine hydrochloride (VITAMIN B1 [THIAMINE HYDROCHLORIDE]) taken for covid-19 immunisation; and cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]). The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration (left arm), at the age of 66-year-old, on 23Jan2021, single dose for COVID-19 immunization and experienced muscle and nerve on both side of face (especial jawline area) are uncomfortable. On 21Feb2021 at 07:00 am, her muscle and nerve on both side of her face (especial jawline area, marionette line area, nasolabial folds, both temples and lower eyelid region) and the area along the back of both ears on the back head are very uncomfortable. From thumb finger till middle figure of both hands are numb especially after getting up daily. The nerve of both front elbows is uncomfortable a lot stronger (e.g. sensation of soreness and distention). Both gums are very soreness and distention. Stuffy nose and night sweats in the whole body happen a few times daily after the 2nd dose as well. The patient did not have covid prior vaccination and was not tested for covid post vaccination. The patient did not receive any treatment in response to the events. Outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 66 | 2021-03-15 | nausea |
I had no reaction after the 1st dose administered on January 26, 2021 other than a slightly sore arm...
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I had no reaction after the 1st dose administered on January 26, 2021 other than a slightly sore arm. After the second dose on Febrary 16, 2021, I expereinced the following in the following order. I did not feel better/normal until March 12. 101 fever for 24 hours, headache for days, chills, slight nausea, pain and aches all over and in joint areas, pain under shot arm in gland areas, black eyes and eye aches, divertiulitus event, brain fog - not being able to have sharp recall, and hives last 7 days.
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| 66 | 2021-03-16 | abdominal pain, abdominal discomfort, diarrhea |
Abdominal cramping and extreme discomfort, diarrhea, loose stool, multiple bathroom trips. Some chi...
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Abdominal cramping and extreme discomfort, diarrhea, loose stool, multiple bathroom trips. Some chills and fatigue. Started about 2 days after the vaccine shot and lasted for about 2 days. Took Pepto Bismol 3 times. It may have helped a little.
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| 66 | 2021-03-16 | decreased appetite |
I received the vaccination at the clinic. About 24 hours after receiving the vaccination, my urine ...
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I received the vaccination at the clinic. About 24 hours after receiving the vaccination, my urine became very dark (amber) and stayed this way for 9 days. I was not dehydrated. Five days after the vaccination, my stool became very pale (clay color) and stayed this way for 6 days. Both conditions resolved on their own. I was very tired for a couple of days after the vaccination, had some soreness in the vaccination site and my appetite was off a little for a few days. These were the only other symptoms.
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| 66 | 2021-03-16 | difficulty swallowing |
Patient and husband at drive thru vaccination clinic on 3/12/21. Vaccination given at 1519. EMS call...
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Patient and husband at drive thru vaccination clinic on 3/12/21. Vaccination given at 1519. EMS called to vehicle at 1527. RN arrived a few minutes later. Per EMS report: Patient complained of itching all over, trouble swallowing, throat tightness, legs hurting, and raspy voice. No hives present and injection site normal. Per EMS report VS- BP:165/81 P:100 O2: 98% on RA End Tidal CO2: WNL EMS administered 50mg Benadryl IM at 1541 and IV started. Departed in ambulance.
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| 66 | 2021-03-16 | vomiting, nausea |
The evening after patient received vaccine, she started to develop low grade fever and urticarial ra...
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The evening after patient received vaccine, she started to develop low grade fever and urticarial rash at the vaccine site. The urticaria improved the following day, as did the fevers. Then 3/5, the fevers started again, several times per day, as high as 102 at home. In association with the fever she has had some mild nausea, x1 non-bloody emesis last night, as well as rigors/night sweats. She went to urgent care and eventually was admitted to the hospital for the following 9 days. During this admission, she continued to have fevers intermittently as high as ~103. She also developed more generalized urticarial rash (worst on trunk), and lab abnormalities including low platelets and elevated liver function tests. She had extensive testing, ultimately determined likely vaccine reaction, started on prednisone 40 daily and improved for discharge to home on 3/17 without fevers x48 hours and with improving labs.
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| 66 | 2021-03-17 | abdominal distension, flatulence, constipation |
Bloating; Constipation; Gas; Headache; This is a spontaneous report from a contactable consumer repo...
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Bloating; Constipation; Gas; Headache; This is a spontaneous report from a contactable consumer reporting for himself and his wife. This consumer reported similar events for two patients. This is the second of two reports. A 66-year-old female patient (reporter's wife) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL8982), intramuscular on 26Jan2021 at a single dose on the right arm for COVID-19 immunization. The patient had no medical history and there were no concomitant medications. The patient did not have prior vaccinations within 4 weeks of the COVID vaccine. The reporter called for himself and his wife. He reported that they looked at the at the symptoms on the vaccine fact sheet and they did not have any of those symptoms. They received the first dose of the vaccine on 26Jan2021. The first couple of days they had a little bit of a headache starting on 27Jan2021. The third day, 29Jan2021, they started having constipation and bloating which is not normal for them. They are having a lot of gas and are very bloated. The reporter and patient was asking if anyone else has reported this since it is unusual for them. The patient then stated that she had just a very mild headache. She has been able to go to the bathroom a little bit. Usually she is going to the bathroom a lot. The patient stated that the gas and bloating is unreal. All she had last night was chicken broth and a piece of toast for dinner. She took Tylenol for the headache. She is not taking anything for constipation. She is drinking caffeinated coffee which she never drinks or she would be going to the bathroom all day. She just wishes she could fart. The outcome of headache was recovered on 29Jan2021. The outcome of bloating, constipation and gas was not recovered.
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| 66 | 2021-03-17 | decreased appetite |
temp over 101; severe headache; body aches; neck ache; extreme fatigue; beginning approximately 11P...
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temp over 101; severe headache; body aches; neck ache; extreme fatigue; beginning approximately 11PM on 3/16/21, worsened as the day progressed; loss of appetite
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| 66 | 2021-03-17 | indigestion | heart racing, heartburn, have no energy |
| 66 | 2021-03-17 | nausea |
Pt. stated she felt nauseous 15 minutes after getting vaccinated. Pt also stated she is terrified ...
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Pt. stated she felt nauseous 15 minutes after getting vaccinated. Pt also stated she is terrified of needles. Vitals taken. HR 95, O2 sat 99%, BP 153/74, R 20. At 2:47 pt. stated she is feeling better and wants to go home.
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| 66 | 2021-03-18 | abdominal pain |
Abdominal pain started 3 days after vaccine . Wheezing started approximately 10 minutes after recei...
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Abdominal pain started 3 days after vaccine . Wheezing started approximately 10 minutes after receiving vaccine. Wheezing resolved before leaving observation area. She was kept in observation area for 30 minutes. Went to Ed for abdominal pain. Has history of post surgical nerve pain. Consulted her MD who felt the vaccine may have aggravated the previous scar tissue, pain issues. CAT scans have been clear. Lost control of right leg 3 days after vaccine. Was seen in ED RPH. She was directed her second Pfizer vaccine needs to be given in a more controlled medical environment.
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| 66 | 2021-03-18 | decreased appetite | No appetite. Feeling tired. |
| 66 | 2021-03-18 | diarrhea |
Chronic diarrhea since about a week after the first vaccine. It's been two months now, and no relief...
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Chronic diarrhea since about a week after the first vaccine. It's been two months now, and no relief. I just saw a NP this week about it. Also, one week after the 2nd Pfizer injection, I had a headache all day (very unusual for me) and felt strange, not well, weird, had to go to bed at 6:30 pm because I just felt flu like symptoms. I slept all night and was fine the next day, accept for the diarrhea.
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| 66 | 2021-03-18 | difficulty swallowing |
Possibly coincidental. The next day and for 5 days I had a terrible sore throat with difficulty swal...
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Possibly coincidental. The next day and for 5 days I had a terrible sore throat with difficulty swallowing. The pain moved from left to right in the throat. Also and worse: swollen mouth tissue and gums: agonizing. Lymph nodes in neck very sensitive to touch. *****This was strange because at the beginning of the pandemic, I had these same symptoms three times: March 10, March 22, and April 28. I had a Covid test after 3rd time and it was negative. Consulted with doc, could not go to office for swab of throat because might be Covid. Had Covid test, negative. Started Amoxicillin for one week. Am feeling better.
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| 66 | 2021-03-18 | nausea, constipation, appendicitis, abdominal pain lower |
RLQ pain (without radiation), nausea, malaise and some constipation. Patient reported pain to be pre...
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RLQ pain (without radiation), nausea, malaise and some constipation. Patient reported pain to be pressure, sharp and shooting, and 7/10 in intensity. Acute appendicitis and localized peritonitis. Patient underwent laparoscopic appendectomy.
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| 66 | 2021-03-18 | nausea |
1:50 pm patient complained of HA, dizziness, nausea. Provided water, elevated legs, observed x 5 min...
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1:50 pm patient complained of HA, dizziness, nausea. Provided water, elevated legs, observed x 5 minutes. Patient's color became very pale. EMS notified. Placed on O2 at 3L NP. SATS on RA 95%; after O2 improved to 98%. Initial VS 182/110 (2:05 pm); p 78; R. 30 - irregular. Glucose - 100dl BP 212/113; p 78. R 30. Nausea better. Sipping water. Refused food. 1415hrs. Fire/rescue arrives at 1420. Assessed patient. She initially refused transport, but later gave her consent. 1438 Transported to ER.
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| 66 | 2021-03-18 | vomiting |
12:45 Received Pfizer #2 13:00 Felt dizzy, lightheaded; consumed water and chocolate 13:05 Transport...
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12:45 Received Pfizer #2 13:00 Felt dizzy, lightheaded; consumed water and chocolate 13:05 Transported to EMS area of observation area; in wheelchair lost consciousness and had brief 15-20 second seizure 13:10 Repeated bouts of emesis. Patient had marked pallor and diaphoresis 13:35 EMS transport arrived, placed IV, gave phenergan, and transported via ambulance to Hospital Center
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| 66 | 2021-03-19 | nausea, diarrhea |
At 10:30 pm Tuesday night massive diarrhea for 3 hours until stool ran clear. There has been consta...
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At 10:30 pm Tuesday night massive diarrhea for 3 hours until stool ran clear. There has been constant nausea everyday since then, including today. Nausea gets less intense every day. There has not been any fever.
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| 66 | 2021-03-20 | constipation, vomiting, abdominal pain lower |
tiredness, headache, chills, severe pain in lower left abdominal region, muscle tightness in right c...
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tiredness, headache, chills, severe pain in lower left abdominal region, muscle tightness in right calf, repeated vomiting, constipation
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| 66 | 2021-03-20 | nausea, vomiting | N/v, confusion, headache, chills, weakness |
| 66 | 2021-03-20 | nausea |
Persistent head ache, starting as mild headache on the evening of March 16, 2021, and increasing in ...
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Persistent head ache, starting as mild headache on the evening of March 16, 2021, and increasing in intensity in the morning of March 17, 2021. I felt chilled and spent much of the day in bed covered with a sleeping bag/quilt, while putting ice packs on my head and neck. The pain lessened by the night of March 17, 2021. There were twinges of headache pain on March 21, 2021. (I have had very few headaches in my life.) There was also some nausea and intestinal distress.
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| 66 | 2021-03-21 | nausea | Chills, aches, fatigue, nausea |
| 66 | 2021-03-21 | stomatitis |
Swelling and soreness in mouth - gums - checks. Very dry. As of 3/22/21 sores almost gone but dry mo...
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Swelling and soreness in mouth - gums - checks. Very dry. As of 3/22/21 sores almost gone but dry mouth has not. No issues prior to having vaccine.
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| 66 | 2021-03-21 | vomiting, nausea |
Patient was sitting s/p vaccination waiting 15 min. She became diaphoretic, nauseous, and pale. She ...
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Patient was sitting s/p vaccination waiting 15 min. She became diaphoretic, nauseous, and pale. She vomited twice. She stated that she thought she had a panic attack. Her vital signs were normal at all times. Last set of vitals 97.6 po, 126/84, 77, 98%
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| 66 | 2021-03-22 | nausea |
Got flu like systems the following day and each day felt weaker with headache and ear and neck pain ...
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Got flu like systems the following day and each day felt weaker with headache and ear and neck pain thought flu ignored. Then felt worse went to urgent care tested negative for corona virus. Seen by dr on site.12/12/21. Double ear infection. Home with antibiotics, got worse. Face extreme pain went to ER at hospital due to left side face dropping and speech slurring was diagnosed with double ear infection and Bell Palsy on 3/14/2021.
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| 66 | 2021-03-22 | nausea |
Low grade fever, widespread muscle pain (#8 on pain chart) severe headache, mild nausea, fatigue, sw...
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Low grade fever, widespread muscle pain (#8 on pain chart) severe headache, mild nausea, fatigue, swollen , painfull glands in neck, soreness at site of injection that traveled into armpit,
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| 66 | 2021-03-22 | vomiting |
I woke up after a normal night's sleep and found that everything was spinning. Was dizzy and could ...
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I woke up after a normal night's sleep and found that everything was spinning. Was dizzy and could not properly walk. After trying to drink a bit of water, fainted and vomited it all back up. I was weak and tired. Slept or rested all day and by late afternoon was able to hold down some toast and by evening symptoms had resolved. Clearly, I am not sure that this was vaccine related since it occurred 2 wks after vaccination but felt should be reported.
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| 66 | 2021-03-23 | abdominal distension |
Continuous Post nasal drip started right after vaccine and has not gone away after 11 days. Also, m...
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Continuous Post nasal drip started right after vaccine and has not gone away after 11 days. Also, my body is bloated and that has not gone away. I was very thirsty after the vaccine so I drank a lot of water. The bloat does not seem to be lessening. It is very uncomfortable. I don't want to get the second dose of the vaccine if this does not go away as I am afraid it will get worse. Although you do not have that as a side effect of the vaccine there are a lot of other symptoms you do not have but I have heard many people say they get these symptoms after the vaccine. You do not make it easy for people to report their symptoms so how are you keeping track of the symptoms people are experiencing after the vaccine. Most older people are not computer literate and even though I am it was not easy to find out how to report these symptoms. They gave me some way of reporting it by text message but I have an older phone and it won't work on that. Most older people would not report symptoms on a phone....they are too small. I also have an ipad but it does not do text messages. I suggest you find another way to track symptoms after the vaccine or you are not getting accurate information. This is not the way to do science.
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| 66 | 2021-03-23 | abdominal pain lower |
Arm pain for one day could not lift arm above chest following vaccine on 3/10/2021. Treated with ice...
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Arm pain for one day could not lift arm above chest following vaccine on 3/10/2021. Treated with ice. Intense lower abdomen pain started on 3/17/2021 Went to ER. Kidney infection Treated with IV Morphine Iv Fluids, Cefuroxime
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| 66 | 2021-03-23 | decreased appetite |
Approximately 12 hours after shot (during the night), I woke up with debilitating pain in multiple p...
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Approximately 12 hours after shot (during the night), I woke up with debilitating pain in multiple parts of my body: wrists; left groin and leg; neck/shoulders; lower back and had a headache. All of these areas were thrubbing and interrupted sleep. Also was very weak. Was difficult to get out of bed or a chair and to walk. Also had loss of appetite. At no time, did I have a temperature.(Note: I play tennis so was very active early in the week). The course of the symptoms has lasted 96hours but now seems to be subsiding. After 48 hours of inability to do any normal life activities, I contacted my physician who prescribed a cordtisone shot and anti-inflamatory medication, which I've taken for 2 days.
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| 66 | 2021-03-23 | nausea |
Started overnight (after 9:30pm on 3/23/21: Injection site pain,Tiredness,- The following occurred a...
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Started overnight (after 9:30pm on 3/23/21: Injection site pain,Tiredness,- The following occurred around 8am on 3/24/21: Headache,Muscle pain, Chills, Joint pain, Fever, Nausea, Feeling unwell, Dizziness, Fainting
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| 66 | 2021-03-23 | nausea |
Two weeks after the vaccination I woke up dizzy. Couldn?t walk without balancing assistance, headach...
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Two weeks after the vaccination I woke up dizzy. Couldn?t walk without balancing assistance, headache and nausea. Took Tylenol. Rested 2 hours, still some dizziness, headache, nausea. Improved by 2:30 pm after more rest. I had arm and neck pain , nausea and fatigue for 4 days after the vaccination.
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| 66 | 2021-03-23 | stomatitis |
Felt mild sore throat and noticed that my mouth just did not feel right. Looked with flashlight and...
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Felt mild sore throat and noticed that my mouth just did not feel right. Looked with flashlight and saw lesions and white lines on both sides of my mouth. Since I had a dentist appointment schedule for Tuesday (3/23/21), I called them and they said to keep the appointment and they would check it out. The dentist examined me and the diagnosis was Lichen Planus. They recommended that I report this since this is the first time this ever happened to me and the only thing I recall that was out of the ordinary was getting vaccinated.
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| 66 | 2021-03-24 | nausea, diarrhea |
Neuropathy type sensation in feet, lower legs, hands; difficulty breathing; tongue felt tingly and s...
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Neuropathy type sensation in feet, lower legs, hands; difficulty breathing; tongue felt tingly and swollen; raised red itchy rash on neck, chest and abdomen; swollen lymph glands in throat; diarrhea; sore throat; site soreness; achy joints; headache; nausea; fatigue; Racing heartbeat; throat felt lujeir was closing; tongue felt tingly and swollen; This is a spontaneous report from a contactable healthcare professional (the patient). A 66-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN6205), via an unknown route of administration in the left arm on 06Mar2021 at 16:30 (at the age of 66-years-old) as a single dose for Covid-19 immunization. Medical history was included celiac sprue, Crohns, chronic pancreatitis, psoriasis, osteoporosis, and ulcerative colitis, all from an unknown date and unknown if ongoing. The patient was allergic to penicillin and codeine. The patient previously received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9269) on 13Feb2021 at 11:30 in the left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported however it was reported the patient had other medications in two weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Mar2021 at 16:30, within 5 minutes of injection, the patient experienced Racing heartbeat, difficulty breathing, tongue felt tingly and swollen, throat felt lujeir was closing, and neuropathy type sensation in feet, lower legs, hands. The patient also experienced the typical side effects of site soreness, achy joints, headache, fatigue, nausea, sore throat, diarrhea, swollen lymph glands in throat, and raised red itchy rash on neck, chest and abdomen. Treatment of Benadryl was given for the events as recommended by paramedic which was still being taken on day 4. The clinical outcome of the events racing heartbeat, difficulty breathing, tongue felt tingly and swollen, throat felt lujeir was closing, and neuropathy type sensation in feet, lower legs, hands was recovered on 06Mar2021 (reported as 'last about 10 minutes'); outcome of site soreness, achy joints, headache, fatigue, nausea, sore throat, diarrhea, swollen lymph glands in throat and raised red itchy rash on neck, chest and abdomen was not recovered. It was reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 66 | 2021-03-24 | nausea, vomiting |
Four days of headaches starting 3/12/2021 (onset 7 days following vaccination) following by rapid on...
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Four days of headaches starting 3/12/2021 (onset 7 days following vaccination) following by rapid onset (~6 hr) nausea, vomiting, and encephalopathy with cortical blindness and altered level of consciousness on 3/15/2021. Found to have diffuse white matter hyperintensities on MRI brain. No spinal cord involvement. CSF analysis with lymphocytic pleocytosis. Negative infectious workup. Started on high dose steroids and plasmapheresis for presumed autoimmune encephalitis. Slow improvement in symptoms for the first 10 days following initiation of steroids (present day).
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| 66 | 2021-03-24 | nausea | nauseous |
| 66 | 2021-03-24 | vomiting | headache, fatigue, chills, vomitting, Extremely itchy hives, |
| 66 | 2021-03-25 | abdominal pain |
Severe abdominal pain and cramping starting 12 hours after vaccine. Was severe for 12 hours and th...
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Severe abdominal pain and cramping starting 12 hours after vaccine. Was severe for 12 hours and then improved but has had continued cramping and discomfort for 10 days
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| 66 | 2021-03-25 | diarrhea, nausea |
has been feverish, weak, temperature of 99.8 on 3/25 10:33 PM PDT, neck, and throat hurts, sore musc...
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has been feverish, weak, temperature of 99.8 on 3/25 10:33 PM PDT, neck, and throat hurts, sore muscles, very sore at the injection site, diarrhea, nausea, headache, tender scalp These symptoms are unchanged after 24 hours (started approx 10 pm 3/24 is is now after 10pm 3/25.
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| 66 | 2021-03-25 | nausea |
Received Vaccine on 3/16/21 and on 3/18/21 developed nausea and muscle pain in back, hip, and legs. ...
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Received Vaccine on 3/16/21 and on 3/18/21 developed nausea and muscle pain in back, hip, and legs. Has been taking Aleeve and Tylenol with no relief. Has appointment with PCP this afternoon. Reported PCP gave Steroids, muscle relaxer and antinausea medicine.
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| 66 | 2021-03-25 | vomiting | Vomit headache exhaustion |
| 66 | 2021-03-25 | vomiting |
About 10am started having chills and fever, took 2 tylenol 10:30-11:30am - threw up 4 times 11:30-23...
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About 10am started having chills and fever, took 2 tylenol 10:30-11:30am - threw up 4 times 11:30-230pm - fever and chills, headache 5pm - fever and chills stopped Very low energy thru Friday 3/26
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| 66 | 2021-03-26 | decreased appetite, abdominal pain |
high fever, headaches very ill. Neck stiff and the gland were swollen. could not eat or drink and se...
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high fever, headaches very ill. Neck stiff and the gland were swollen. could not eat or drink and severe pain and weakness.
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| 66 | 2021-03-26 | nausea |
Had expected body aches and chills during the night. Very lightheaded when I got up and some nausea....
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Had expected body aches and chills during the night. Very lightheaded when I got up and some nausea. Thought to ?sit down before you fall down? then ?came to? next to toilet. Head resting on toilet seat. Had some bruising on cheek but don?t remember going to floor. Rest of day was okay with just the most common side effects. Never fainted before but not uncommon for me to be lightheaded with nausea. Most embarrassing...passed some stool.
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| 66 | 2021-03-26 | nausea | Headache, chills, nausea, rash |
| 66 | 2021-03-27 | nausea, abdominal distension, diarrhea |
Approximately 32 hours after injection, I began to feel severe gastric bloating. The diarrhea began ...
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Approximately 32 hours after injection, I began to feel severe gastric bloating. The diarrhea began soon after, and then vomiting. Both projectile (I know, eww). I experienced this every 30-60 minutes for about 7 hours. Then the nausea subsided, and the episodes of diarrhea began to happen at longer intervals. I also experienced cold sweats and the next day my body temperature was reading low (96.4 at one point). My brain fog and weakness were probably the result of dehydration.
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| 66 | 2021-03-27 | nausea |
Extreme chills, low grade fever, nausea, very lethargic, horrible headache - symptoms lasted 2.5 day...
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Extreme chills, low grade fever, nausea, very lethargic, horrible headache - symptoms lasted 2.5 days
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| 66 | 2021-03-28 | decreased appetite |
feels drugged; fluid in her chest that she didn't have before; Coughing and spitting up white mucous...
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feels drugged; fluid in her chest that she didn't have before; Coughing and spitting up white mucous out of her chest; feels so tired; no appetite, food doesn't taste right; sweating and chills; sweating and chills; feels weak; extremely sick; joints and arms hurt; joints and arms hurt; doesn't feel like walking around/Lethargic; can't hardly even talk to people; Headache; feels like she has been poisoned; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9267), via an unspecified route of administration on Left arm on 09Mar2021 between 15:00 and 16:00 at single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient states she took that shot on Tuesday and she is still sick and still doesn't feel good. States that she feels better, but she is coughing and spitting up white mucous started on 10Mar2021. She feels like she has been poisoned in Mar2021. States that she is coughing stuff up out of her chest. States that she took this on Tuesday (09Mar2021) and still feels drugged and tired. She states that it made her extremely sick and she is not taking the second shot. She states she took the shot Tuesday and didn't get sick until three to four hours after, she was down feeling so bad, like an ailment or disease. She states she feels like we gave her the Covid. She states she won't even go to the hospital because can't trust anyone. States that her joints and arms hurt and can't hardly even talk to people on 09Mar2021. States she has fluid in her chest that she didn't have before on 10Mar2021. States that this is the first day she has gotten out of bed. States that she is not taking the second shot. States that she had to sit for fifteen minutes after her shot and she felt fine. Clarified that she couldn't eat, she had sweating and chills for two to three days and she couldn't even get out of bed on 19Mar2021. States she feels better but still feels weak and lethargic on 09Mar2021. States it has improved since yesterday. States that her food doesn't taste right but no appetite on 09Mar2021. States the sweating and chills ended 11Mar2021. She states that she had a headache and it started on 09Mar2021 and it went away 12Mar2021 with treatment of Aspirin. Not sure if she is going to recover. Prior to vaccination, was the patient was not diagnosed with COVID-19. The outcome of events Poisoning; feels drugged, extremely sick was unknown, for Coughing and spitting up white mucous out of her chest was not resolved, for headache it was resolved on 12Mar2021, for feels so tired; no appetite, food doesn't taste right; joints and arms hurt; doesn't feel like walking around; can't hardly even talk to people; feels weak; Lethargic was resolving, for fluid in her chest that she didn't have before was not resolved, for sweating and chills it was resolved on 11Mar2021. Follow-up attempts are completed. No further information is expected.
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| 66 | 2021-03-28 | retching | chills, dry heaves, dizzy, headache continuing for 13 hours so far |
| 66 | 2021-03-30 | abdominal pain upper, nausea |
body aches; stomach pains; tiredness; feeling unwell; nausea; Body tingling; dizziness; This is a sp...
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body aches; stomach pains; tiredness; feeling unwell; nausea; Body tingling; dizziness; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA) vaccine (Formulation: Solution for injection, Lot Number: EL8982, Expiry date: Unknown) via an unspecified route of administration in left arm on 10Feb2021 09:00 as single dose for covid-19 immunisation. Medical history included chronic depression, high cholesterol and first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA) vaccine (Formulation: Solution for injection, Lot Number: EL3248, Expiry date: Unknown) via an unspecified route of administration in left arm on 21Jan2021 17:15 as single dose for covid-19 immunisation. There was no special history of allergies. Concomitant medications included citalopram 20 mg, aripiprazole 2 mg and rosuvastatin for an unspecified indication. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 10Feb2021 09:00, the patient experienced body tingling and dizziness. 3 days after injection on 14Feb2021, the patient experienced body aches, stomach, tiredness, feeling unwell and nausea. The patient hasn't been tested PCR for COVID-19 since the vaccination. Therapeutic measures were not taken as a result of adverse events. The outcome of the events were reported as recovering.
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| 66 | 2021-03-30 | decreased appetite |
drop in blood pressure; swelling of the face and throat; swelling of the face and throat; fast heart...
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drop in blood pressure; swelling of the face and throat; swelling of the face and throat; fast heart beat; no appetite; exacerbation of existing neuropathy; Palpitations; being lightheaded; sweating; burning mouth syndrome; burning mouth syndrome; especially burning mouth syndrome - nerve endings in tongue, lips and cheeks were all on fire; especially burning mouth syndrome - nerve endings in tongue, lips and cheeks were all on fire.; especially burning mouth syndrome - nerve endings in tongue, lips and cheeks were all on fire.; Some of my reactions look like an allergic reaction; difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 66-years-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EL3302, expiry date not reported) via an unspecified route of administration, administered in left arm on 11Mar2021 14:00 at a single dose for COVID-19 immunisation. Medical history included neuropathy from 2006 and ongoing, since she had chemotherapy in 2006 for breast cancer in 2006 and burning mouth syndrome. The patient had no covid prior vaccination. The patient had no known allergies. The patient had other medications in two weeks which included unspecified dietary supplements. The patient had no other vaccine in four weeks. The patient previously took doxycycline from 2010 to an unknown date for Lyme's diseaseand experienced burning mouth syndrome. On 11Mar2021 at 02:00 PM, patient had palpitations, being lightheaded, sweating, exacerbation of existing neuropathy and especially burning mouth syndrome - nerve endings in tongue, lips and cheeks were all on fire. These symptoms still continue. Patient stated that people were talking about the second dose being worse. Patient stated that some of the reactions in Mar2021 look like an allergic reaction. They (HCP) only have cautioned the patient about difficulty breathing in Mar2021. They were saying there wasn't anything they can do for it. Patient asked how long the side effects will last and how to go about changing the appointment. If they are going to continue, patient was very concerned about following up with the second shot and asked if they can have that second shot be postponed until patient was not experiencing these side effects to the effect that she was. She completed the self-reporting on Monday (15Mar2021), but because her side effects were not going away she wanted to reach out to someone. She has reached out to her practitioner and had an appointment yesterday. Doctors didn't really know because it was all very new. She had the first vaccination shot on 11Mar2021, almost a week ago. In the 15 minutes that she waited afterwards she definitely experienced palpitations and a feeling of lightheadedness. She has an underlying condition of burning and pain called neuropathy. She has had neuropathy since she had chemotherapy in 2006 for breast cancer. This exacerbated that. She had been very concerned about that prior. Everyone said and the CDC recommends even with neuropathy to go ahead with the vaccine. It also triggered another underlying condition. She had a reaction to a course of Doxycycline in 2010 for Lyme's disease that caused burning mouth syndrome. Both of these things were really acute now, the neuropathy and burning mouth syndrome. Monday (15Mar2021) was a particularly bad day because the symptoms of an allergy which were swelling of the face and throat, fast heart beat, and dizziness were with the burning mouth syndrome. She didn't have difficulty breathing. It was the nerve endings of the tongue that go all the way to the back of her throat and gave the sensation of the whole mouth being involved. Monday was difficult. It was 8 hours of an acute episode then it eased off a little that evening. She had no appetite on Monday and barely ate anything. Yesterday was ok and much better although she was being triggered by environmental thing such as food and toothpaste. Things she normally uses were setting it off. She had an acute reaction this morning to a protein shake she has had every day for 14 years. The reaction this morning, 17Mar2021, was a drop in blood pressure and palpitations. It passed. She has been documenting this and made her provider aware of what she was experiencing. She was participating in the V-Safe through the CDC that checks up on her everyday and asks about symptoms. She didn't know if she was supposed to report this to the vaccine adverse event system or not. Obviously, she didn't want to get COVID. She was struggling with the recommendation to get second shot because she was extremely concerned. She wanted to know how long will the side effects will last and if she can postpone getting the second shot until she gets reasonably well. No practitioner can recommend whether to do it or not to do it. She reported this information online to Pfizer on 15Mar2021. She provided the lot number when she reported it online. The patient was not tested for COVID post vaccination. No treatments received from the events had palpitations, being lightheaded, sweating, exacerbation of existing neuropathy and especially burning mouth syndrome - nerve endings in tongue, lips and cheeks were all on fire. The patient recovered with lasting effects from the events had palpitations, being lightheaded, sweating, exacerbation of existing neuropathy and especially burning mouth syndrome - nerve endings in tongue, lips and cheeks were all on fire. The outcome of the other reported events was unknown.
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| 66 | 2021-03-30 | difficulty swallowing |
having problems swallowing, she kept getting choked when drinking water; she said the fatigue was ri...
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having problems swallowing, she kept getting choked when drinking water; she said the fatigue was ridiculous, and the fatigue knocked her off her feet; feeling jittery and irritable; feeling jittery and irritable; This is a spontaneous report from a contactable consumer. This 66-Year-old female consumer (patient) reported for herself that she received the second dose of BNT162B2 (Pfizer-Biontech COVID 19 vaccine, Lot number EN6200) at single dose for COVID-19 immunisation on 26-FEB-2021 at 11:30. Relevant history was unknown. The patient previously received Pfizer-Biontech COVID 19 vaccine on 05Feb2021 for COVID-19 immunisation. Past drug included mild blood pressure medication. Relevant concomitant drug was unknown. The patient has fatigue, she kept getting choked when drinking water, feeling jittery and irritable since 28Feb2021. She said the fatigue was ridiculous, and the fatigue knocked her off her feet. The patient asked if there was something she could do for the fatigue she was experiencing. This reaction was really not good. She was having problems swallowing. She said the swallowing problem started at the same time as the fatigue on Sunday, 28Feb2021. No treatment was received for the events. The outcome of event having problems swallowing was not resolved. The outcome of other events was unknown.
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| 66 | 2021-03-30 | nausea, indigestion |
Chest pain; Pressure in head & face; Pressure in head & face; Pains in nape, across the shoulders an...
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Chest pain; Pressure in head & face; Pressure in head & face; Pains in nape, across the shoulders and front/top head; Weakness in arms right worse than left; Tingling in right hand; Nausea; Salty taste in mouth; Elevated blood pressure; Dry mouth; Indigestion; This is a spontaneous report from a contactable consumer (patient herself). A 66-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3246), via an unspecified route of administration in left arm at the age of 66-years (non-pregnant at the time of vaccination), on 01Feb2021 at 08:00 AM at a single dose for COVID-19 immunization. The patient's medical history included osteopenia and allergies to PCN (penicillin) and latex. Concomitant medication included glucosamine, curcuma longa (TURMERIC [CURCUMA LONGA]), fish oil (OMEGA 3 [FISH OIL]), calcium citrate (CITRACAL [CALCIUM CITRATE]), colecalciferol (VIT D3), cranberry, and biotin. The patient previously took first dose of bnt162b2 (Lot number: EK9231), via an unspecified route of administration in left arm at the age of 66-years, on 13Jan2021 at single dose for COVID-19 immunization. The patient received other vaccine in four weeks was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID. The patient experienced pressure in head & face, pains in nape, across the shoulders and front/top head, weakness in arms right worse than left, tingling in right hand, nausea, salty taste in mouth, elevated blood pressure, dry mouth, and indigestion on 05Feb2021. The patient also experienced chest pain on 10Feb2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood pressure measurement on 05Feb2021: elevated; nasal swab on 11Feb2021: pending result. The patient received paracetamol (TYLENOL) and ibuprofen (ADVIL) as treatment for the events. The patient also used heating pad and icepack as treatment for the events. The outcome of the events was not recovered.
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| 66 | 2021-03-30 | nausea |
feeling very tired; headache; Muscle pain; Joint pain; Nausea; feeling unwell like the flu; feeling ...
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feeling very tired; headache; Muscle pain; Joint pain; Nausea; feeling unwell like the flu; feeling unwell like the flu/awful; This is a spontaneous report from a contactable consumer (patient herself). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9261) intramuscularly on 21Jan2021 at single dose in left arm for COVID-19 Immunization. Medical history and Concomitant medications were not reported. It was reported that she wanted to report reaction to Pfizer Covid 19 vaccine. stated she was very tired, headache, muscle pain, joint pain, nausea, feeling unwell like the flu. Was injected on 21Jan2021 and this started on 22Jan2021. stated that it has been awful since then. Is her first shot. Stated that since she had such a bad time with the first one should she get the second one. stated that the outcome of feeling very tired and muscle pain varies and cannot be directly determined. Stated that feeling very tired and muscle pain is ongoing. Treatment was reported as none. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.
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| 66 | 2021-03-30 | nausea |
Nausea; fatigue; chills; 99.6 temperature; This is a spontaneous report from a contactable consumer ...
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Nausea; fatigue; chills; 99.6 temperature; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: EM9809; Expiration Date: unknown) via an unspecified route of administration, in right arm on 09Feb2021 13:45 at single dose for COVID-19 immunisation. Medical history included complex regional pain syndrome, CRPS (non-active), fibromyalgia, multiple non-life-threatening allergies to medications and environmental. The patient not-receive any other vaccines within 4 weeks prior to the COVID vaccine. other medications the patient not received within 2 weeks of vaccination; Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. On 11Feb2021 11:00, the patient experienced nausea, fatigue, chills, 99.6 temperature. On 11Feb2021, the patient underwent lab tests and procedures which included body temperature: 99.6 The outcome of events was not recovered. No follow up attempts are possible. No further information is expected.
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| 66 | 2021-03-30 | vomiting |
I woke up the following morning (March 5) having chills, vomiting, and very very weak-----but no fev...
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I woke up the following morning (March 5) having chills, vomiting, and very very weak-----but no fever. On Saturday I was better but still weak and that is when cellulitis started in my left leg. On March 7, 2021, I was seen in the ER. I was given a shot and antibiotics and told to return if not better. So on Monday, March 8, I returned to ER and then was admitted to the hospital. I was allowed to go home on Saturday, March 13. Since then I had two sores to develop on my left leg. I had to have wound surgery on them on March 25. I am a lot better but still not completely well.
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| 66 | 2021-04-01 | nausea, retching |
3/30/21: Patient presented and was admitted for abnormal labs, nausea and dry heaving x 1 week. On a...
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3/30/21: Patient presented and was admitted for abnormal labs, nausea and dry heaving x 1 week. On admission, patient was found to be hypokalemic (K 2.2), creatinine of 4.81. Patient received second dose of COVID vaccine this morning. Patient was tested positive for Covid-19 at this visit. Per the EUA, hospitalizations to be reported irrespective of attribution to vaccine.
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| 66 | 2021-04-06 | diarrhea, nausea |
After dose 1 on 02/24/2021 in right arm had typical side effects: sore arm, headaches, fatigue, nau...
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After dose 1 on 02/24/2021 in right arm had typical side effects: sore arm, headaches, fatigue, nausea, diarrhea. Nausea & diarrhea stopped after ~ 3 days. Headaches, fatigue continued for about 2 weeks possibly longer. Also began having intermittent facial twitching on right side: cheek, cheekbone. Twitching continued interittently for ~2 wks or more, all on right side of face. After dose 2 on 03/17/2021 in LEFT arm, my dominant arm, side effects included: sore arm, headaches, fatigue, nausea. Nausea ended after ~2 days. Headaches and fatigue continued intermittently for ~10+ days.
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| 66 | 2021-04-06 | nausea, diarrhea |
After dose 1 on 02/24/2021 in right arm had typical side effects: sore arm, headaches, fatigue, nau...
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After dose 1 on 02/24/2021 in right arm had typical side effects: sore arm, headaches, fatigue, nausea, diarrhea. Nausea & diarrhea stopped after ~ 3 days. Headaches, fatigue continued for about 2 weeks possibly longer. Also began having intermittent facial twitching on right side: cheek, cheekbone. Twitching continued interittently for ~2 wks or more, all on right side of face. After dose 2 on 03/17/2021 in LEFT arm, my dominant arm, side effects included: sore arm, headaches, fatigue, nausea. Nausea ended after ~2 days. Headaches and fatigue continued intermittently for ~10+ days. Adverse event described in on Continuation Page.
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| 66 | 2021-04-11 | diarrhea, vomiting |
My mother became very ill-- labored breathing, chills, slight fever, body aches, throwing up and dia...
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My mother became very ill-- labored breathing, chills, slight fever, body aches, throwing up and diarrhea throughout the weekend. By Sunday (48 hours later), she was having black outs and ended up passing away on Monday, March 22, less than 72 hours later. She was fine without symptoms prior to the shot.
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| 66 | 2021-04-11 | vomiting, nausea |
Reports to ED with nausea, vomiting 2 days after 2nd covid vaccine. Admitted to hospital as patient ...
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Reports to ED with nausea, vomiting 2 days after 2nd covid vaccine. Admitted to hospital as patient also had recent abdominal surgery. Treated for gastroparesis and discharged home.
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| 66 | 2021-04-12 | abdominal pain upper |
four days after second shot, severe stomach pain, fevers, trouble urinating, chest pain, . turned in...
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four days after second shot, severe stomach pain, fevers, trouble urinating, chest pain, . turned into kidney infection, blood infection and having AFIB, need for pace paker.
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| 66 | 2021-04-13 | abdominal pain, diarrhea, constipation |
developed severe abdominal pain; multiple CT scans of abdomen, treated with abx no better, originall...
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developed severe abdominal pain; multiple CT scans of abdomen, treated with abx no better, originally had diarrhea then constipation original felt to have diverticulitis labs normal sigmoidoscopy - swollen sigmoid hospitalized, symptoms resolved
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| 66 | 2021-04-14 | abdominal pain, nausea |
Severe abdominal pain,nausea,emergency hospital visit,atrial fibrillation,thrombosis,left.kidney inf...
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Severe abdominal pain,nausea,emergency hospital visit,atrial fibrillation,thrombosis,left.kidney infarct.admittance to local hospital for 5 days and ongoing follow up testing and multiple specialist visits for months
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| 66 | 2021-04-15 | diarrhea, vomiting |
Received second shot on April 2@ 1130am. Started with diarhhea and vomiting's on April 6 at 3:30 a...
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Received second shot on April 2@ 1130am. Started with diarhhea and vomiting's on April 6 at 3:30 am. Continued to 4:30 am on April 10. Slight elevated temperature at 99.1 . On morning of April 11 couldn't put pressure on right side, leg and arm, facial numbness. Went to er and they said I was having a stoke, transferred to hospital. MRI done verified Stroke with blood clot to Left thalamus Sent home and will be receiving PT and OT.
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| 66 | 2021-04-23 | abdominal discomfort, diarrhea |
Lost her sense of taste and smell; Lost her sense of taste and smell; Tested positive for Covid afte...
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Lost her sense of taste and smell; Lost her sense of taste and smell; Tested positive for Covid after receiving first dose of vaccine; Tested positive for Covid after receiving first dose of vaccine; Fever; body aches; Diarrhea; stomach symptoms abdominal discomfort; This is an initial spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNTl62B2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL8982; Expiration Date: 20May2021) first dose via an unspecified route of administration and administered in right arm on 23Jan2021 14:00 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. Past drug included When she gets the flu shot, she gets a low grade fever and body aches for about 1 night. No Lot/NDC/Expiry for any of those Flu shots. States that this happens every year. On 08Feb2021 patient underwent lab test and procedures which included COVID-19 test and tested positive for first dose vaccine. Patient about the Covid-19 Vaccine. States that she doesn't know if there is something for self reporting, but her mom and her husband both got the vaccine, then 16 days later got symptoms of Covid, then on the 17th day, tested positive for Covid; and this was after the first dose of the vaccine. States that her mom, is on day 12 of Covid and still having symptoms. States that she was tested for Covid-19 on 08Feb2021, and it resulted on 10Feb2021 as positive. She started having symptoms such as body aches on 07Feb2021 to 08Feb2021, and the fever started 08Feb2021 to ongojng. She still had a fever yesterday. Caller states that the fever would disappear for a day or two, then come back, and this has been going on for the last 10 days. She also lost her sense of taste and smell about a week ago, and got it back about 1.5 days ago. Also had stomach symptoms as well, had diarrhea on 06Feb2021 and 17Feb2021, resolved that day 17Feb2021. The outcome of the events like Drug ineffective and SARS-CoV-2 test positive were unknown, pain, Ansomia, Ageusia and Diarrhoea was recovered and fever was not recovered.
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| 66 | 2021-04-23 | vomiting |
fever of 101.3; full body muscle pain; headache; vomiting; This is a spontaneous report from a conta...
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fever of 101.3; full body muscle pain; headache; vomiting; This is a spontaneous report from a contactable consumer or other non hcp. A 66-year-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: 9809; Expiration Date: unknown) via an unspecified route of administration, in Arm Right on 09Feb2021 08:15 for COVID-19 immunization.The patient previously took first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: 3247; Expiration Date: unknown), via an unspecified route of administration, in Arm Right on 19Jan2021 08:15 for COVID-19 immunization. The patient previously took Levaquin and bnt162b2.Medical history included neuropathy peripheral, rosacea, drug hypersensitivity to levaquin. Concomitant medications included vitamins (MULTIPLE VITAMIN), ciclosporin (RESTASIS), calcium and omega 3 taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Feb2021 22:00, the patient experienced fever of 101.3, full body muscle pain, headache, vomiting. The patient underwent lab tests and procedures which included body temperature: fever of 101.3 on 09Feb2021. The outcome of the event was recovered.
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| 66 | 2021-04-26 | diarrhea, nausea, abdominal pain upper |
terrible headaches; fever; nausea; terrible stomach pain; colitis; fatigue; diarrhea; she was sick; ...
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terrible headaches; fever; nausea; terrible stomach pain; colitis; fatigue; diarrhea; she was sick; This is a spontaneous report from a contactable consumer or other non hcp. A 66-years-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN5318) as SINGLE DOSE for covid-19 immunisation. Medical history included sore arm as a side effect when she had a pneumonia shot. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EL1283) as SINGLE DOSE for covid-19 immunisation and had a sore arm for 2 days and joint pain for over a week.On an unspecified date after 2 dose of vaccine, patient experienced terrible headaches, fever, nausea, terrible stomach pain, fatigue, diarrhoea, colitis which she had never had before and she was sick. It was reported that at the end of the week patient started feeling better, however she started with diarrhea again and its been for over a week. If she eats anything she had to go right to the bathroom (banana, rice, turkey, eggs (8 pounds to begin), she was trying to hydrate herself. She started eating lightly trying to heal, and after a week she thought she was better, now her stomach was a wreck. Patient wanted to know the duration of these symptoms and if vaccine could have been contaminated and if she was going to have this gastric symptom for a long time or the whole time.She would like to know how the vaccine works and how does it leave your system. She says that the minute she got home she had the runs, it went right through her. She says she started eating lightly trying to heal, and after a week she thought she was better, now her stomach was a wreck. She says she had done a report before. Caller says that she would like to report that and ask question, since the vaccine was in her, would this always be a problem, it feels like she had colitis which she has never had before. She said she could not get to her doctor for an appointment for a few days, and she would like to know if it could be her IBS. She said with a normal medication she could drink a lot to get it out of her system, but with a vaccine she was not sure of what she could do. She says after the second time she did an online report and then she was starting to feel much better then her stomach exploded again. Caller says she can't eat much, and she was wondering how the vaccine works, since it was still in her and irritating her. The outcome of the event's terrible headaches, fever, nausea, terrible stomach pain, fatigue, colitis and she was sick were reported as unknow and the outcome of diarrhoea was not recovered. Information on batch number has been requested.
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| 66 | 2021-04-26 | nausea, diarrhea, decreased appetite, constipation |
nervous; Back pain, butt and legs hurt, feels like Sciatica; Back pain, butt and legs hurt, feels li...
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nervous; Back pain, butt and legs hurt, feels like Sciatica; Back pain, butt and legs hurt, feels like Sciatica; Back pain, butt and legs hurt, feels like Sciatica; Back pain, butt and legs hurt, feels like Sciatica; Constipated; Doesn't sleep through the night; Headache lasted for days and days; No appetite, lost 6 pounds in a week; No appetite, lost 6 pounds in a week; Tired; Diarrhea; Nausea; felt like Dumping Syndrome; Stiff neck, like an iron claw; Anxiety reared up; Blacked out; Soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm on 17Mar2021 at 11:30 AM (at the age of 66 years old) (Lot Number: EN6205, unknown expiration) as a single dose for COVID-19 immunisation. Medical history included ongoing anxiety (40 years or more), ongoing depression (46 years ago, at the age of 20), ongoing acid reflux (maybe 25 years), ongoing GERD (maybe 25 years), ongoing Barrett's esophagus (for 12 years), mild to moderate COPD since 2011, gastric bypass (a year and a half ago), and lost 120 pounds. Concomitant medications included bupropion for anxiety depression and omeprazole for acid reflux, both ongoing. The patient previously received flu and tetanus on unspecified dates for immunization and both experienced hard red welt on arm (welt was hard and lasted for 5-7 days). The patient reported no side effects for 12 hours, but a little soreness at injection site on 17Mar2021 at 20:00 (8:00 PM). Her arm wasn't heavy, but she had an awareness of the soreness. She has had life-long anxiety and depression. Several weeks ago (on 26Mar2021), her anxiety reared up, and it could have been due to a family situation. On the 9th day after the first shot, she was having a therapy appointment on the phone and talking about her anxiety, and she got a stiff neck, like an iron claw (26Mar2021 at 10:00 am). It lasted for a couple of 5 minutes and she laid down on the couch then on the floor. Her therapist said to call 911. Emergency medical technicians came to her house and they said all of her numbers looked good. She went to the hospital, and was in the emergency room for several hours, but she only remembers one hour of it. She also had diarrhea and nausea on 26Mar2021 at 11:30, and it felt like Dumping Syndrome, that one can have from a gastric bypass. She was only aware for one hour at that point and blacked out (on 26Mar2021). With regards to nausea, she mostly saw bile in the bag, all she had that day was a protein drink. She was back home and the next day, she did not remember how she got home. She hasn't had blackouts anymore but feels it may be from heightened anxiety. On 27Mar2021 at 09:00, she had no appetite, lost 6 pounds in a week, and was tired. She had headache lasted for days and days on 29Mar2021 at 09:00 AM. She is slowly improving but she still doesn't sleep through the night on 29Mar2021 at 16:00. It was like a feeling like she was resetting her surgery, like she didn't care about eating. The also experienced back pain, butt and legs hurt, feels like sciatica on 31Mar2021 at 16:00 and was constipated. She is using a stool softener and is back in her routine. She called her primary doctor and could not tell her what happened, and she went in a loop trying to get information and authorizations for her to make a determination of what had happened. Her doctor felt like she should have an MRI. Her heart and all of her numbers looked good, as the emergency medical technicians said. Her primary doctor recommended her to get the second shot. She had cancelled the second shot for this week, and she has rescheduled it for another date. She was afraid that she will black out again, after the next vaccine, and is not sure if that is how her anxiety manifested. The main reasons she is calling is that she had no concerns of side effects prior to the vaccine, and a couple of her neighbors said they had read about side effects of the vaccine, but she was not worried. When the patient started to read about side effects of the vaccine, she understood that on the 10th day, the vaccine starts to be in a person's system and that maybe is why she didn't have initial side effects, but then she had side effects several days later because the vaccine was in her body. By day 10, the vaccine is in effect in the body and she is nervous. Her second vaccine is scheduled on 26Apr2021. The patient would like to know if there is any information on people that have had a gastric bypass. The patient has no prior vaccinations within 4 weeks. The events resulted in emergency room visit (except nervous). The patient recovered from soreness at injection site on 18Mar2021; recovered from diarrhea, nausea, felt like Dumping Syndrome on 26Mar2021; recovered from stiff neck on 26Mar2021 at 10:05am; recovered from constipation on 02Apr2021; and recovered from no appetite and lost 6 pounds on unspecified dates. The patient also recovered from headache with sequelae on unspecified date; and recovered from blacked out on 27Mar2021 with sequelae. The patient had not yet recovered from anxiety reared up; tired; doesn't sleep through the night; back pain, butt and legs hurt, feels like sciatica. No follow-up attempts are possible. No further information is expected.
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| 66 | 2021-05-04 | decreased appetite, nausea |
Malaise; short lasting fever & chills; short lasting headaches; nausea w/o vomiting; loss of appetit...
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Malaise; short lasting fever & chills; short lasting headaches; nausea w/o vomiting; loss of appetite; sleepy; upper body aches; This is a spontaneous report from a contactable consumer (Patient). A 66-year-old non-pregnant female patient received second dose of BNT162B2 (Pfizer Covid-19 vaccine, solution for injection, Lot# unknown) via an unspecified route of administration, administered in left arm on 11 Feb 2021 at 01:30 PM (at the age of 66-years), as a single dose for COVID-19 immunization. The patient received first dose of BNT162B2 (Pfizer covid-19 vaccine, solution for injection, Lot# unknown) via an unspecified route of administration, administered in left arm on 19 Jan 2021 at 02:30 PM, as a single dose for Covid-19 immunization. Medical history included polymyalgia rheumatica. Patient was allergic to ibuprofen and opiates. Concomitant medication was not reported. On 11 Feb 2021 at 01:00 AM, patient experienced short lasting fever & chills, malaise, sharp but short-lasting headaches, nausea w/o vomiting, very sleepy, loss of appetite and upper body aches. The events were long term side effects which were from 2-9 days post second dose of vaccination. Patient did not receive treatment for events. Patient did not receive any other vaccine in four weeks prior vaccination. Patient does not have Covid prior to vaccination and was not tested for it post vaccination. The outcome of all the events of was not recovered. Information on the lot/ batch number has been requested.
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| 67 | 2021-01-03 | nausea |
On my way home from receiving the vaccine, I felt slight numbness in my lips (no further swelling, e...
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On my way home from receiving the vaccine, I felt slight numbness in my lips (no further swelling, etc.). Noticed some circumoral cyanosis around my lips after arriving home. Had a fine afternoon (sleeping following vaccine and 16 hr. shift). Had dinner and usual evening. Upon going to bed about 11pm, I experienced chills for several hours, and shortness of breath. Very weak. Called 911 about 3 am - went to hospital ER - O2 sat. 90% enroute. Vital signs stable in hospital ER. Had neg. CXR, EKG, and labs. Also had slight cough and slight bronchial congestion. Received some IV fluids in ER. Left ER at 7am. Went home and slept all day, slight nausea in am. Awoke at 7pm - had good breakfast for dinner. Fine evening and night. Off the next day from work - usual day. It was like having Covid all over again (positive X2 in April - out of work for 5 weeks). Although the symptoms began about 12 hrs. following the injection and subsided about 24 hrs. later). My colleagues (work as a nurse in long term care - rehab) who had Covid in the past have experienced similar symptoms following the vaccine, even though we had Covid back in the spring. Dreading vaccine number 2 on Jan. 19th - hopefully I will be ok.
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| 67 | 2021-01-05 | nausea |
severe headache, fever, nausea, frequent bowels, injection site pain, chills, joint pain - it felt l...
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severe headache, fever, nausea, frequent bowels, injection site pain, chills, joint pain - it felt like 36 hours of bad flu
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| 67 | 2021-01-07 | nausea, vomiting | Dizziness & NauseaVomiting |
| 67 | 2021-01-07 | nausea | headache, nausea, light sensitivity, neck pain, general not feeling well, not sleeping well |
| 67 | 2021-01-11 | diarrhea |
Received vaccine on 1/4. Woke on 1/5 with cold sweats and painful diarrhea. Called Covi hotline. Ins...
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Received vaccine on 1/4. Woke on 1/5 with cold sweats and painful diarrhea. Called Covi hotline. Instructed to stay home form work until symptoms improved.
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| 67 | 2021-01-12 | vomiting, diarrhea, nausea |
Nausea; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer (works as a non...
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Nausea; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer (works as a non-emergency medical transporter). A 67-year-old female patient started to receive bnt162b2 (BNT162B2 reported as Covid-19 vaccine; lot number: EL1284; expiration date: unknown), via an unspecified route of administration left arm on 31Dec2020 at a single dose for covid-19 vaccination. The patient has no medical history. The patient's concomitant medications were not reported. The patient reported that she had the Covid-19 vaccine last Thursday (31Dec2020). She was asking if nausea, vomiting and diarrhea were side effects since she has experienced these. The outcome of the event vomiting was recovered on 07Jan2021 with sequelae while the outcome of the other events was recovering.
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| 67 | 2021-01-13 | vomiting, abdominal pain upper, nausea |
5 min post injection- nauseous for a few minutes 9 hrs post injection- severe stomach pain and ...
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5 min post injection- nauseous for a few minutes 9 hrs post injection- severe stomach pain and sudden onset vomiting lasting for several hours. Chills and malaise throughout next day.
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| 67 | 2021-01-14 | decreased appetite |
received Pfizer vaccine on 1/11/2021 in Right arm at 9:40 am. Awoke at 12 midnight unable to hersel...
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received Pfizer vaccine on 1/11/2021 in Right arm at 9:40 am. Awoke at 12 midnight unable to herself out of bed, needed to wake husband for assistance due to employee being unable to use Right arm. Developed headache, chills, sweats, joint pain Stated "it felt like I was hit by a bus" felt like I got beat up. Wednesday Headache was gone, R arm swollen, lymph nodes at axilla and R neck large as grapes, painful. No appetite, effort to move .Arm was swollen and reddened at injection site.
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| 67 | 2021-01-14 | decreased appetite |
2nd dose: no ae events 1 nd dose:12/24/20 07:30 PM Heavy head at awakening 4:30 AM, spouse drove p...
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2nd dose: no ae events 1 nd dose:12/24/20 07:30 PM Heavy head at awakening 4:30 AM, spouse drove pt to work; brain fogginess, fatigue arriving home; pt did not eat for 2 days, lethargic; forced self to hydrate; missed work for 4 days. Large lesion roof of mouth l side to larger two front teeth, very painful, Veltrax PCP. Pt regained appetite as lesion went down in mouth. Lesion has resolved, all other symptoms have resolved.
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| 67 | 2021-01-14 | diarrhea |
Fatigue/lassitude, mild mild headache diarrhea start 8 am on 1/12/21 end 8 am on 1/13/21 approx 6 ...
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Fatigue/lassitude, mild mild headache diarrhea start 8 am on 1/12/21 end 8 am on 1/13/21 approx 6 episodes; 2 doses of peptobismol taken no fever
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| 67 | 2021-01-21 | nausea, nausea | HA, SEVERE NAUSEA |
| 67 | 2021-01-23 | diarrhea |
In the middle of night started feeling dizzy and developed soreness in arm at injection site.. Over ...
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In the middle of night started feeling dizzy and developed soreness in arm at injection site.. Over the next few days, I developed symptoms: slight fever of 99.4 F, diarrhea, unable to eat much, malaise, still dizzy and sort of "blanking out" at times. Arm pain lessened in 2 1/2 days.
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| 67 | 2021-01-23 | nausea, vomiting |
Within 2 hours of receiving my second Covid 19 vaccine I developed fever, chills, nausea, vomiting, ...
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Within 2 hours of receiving my second Covid 19 vaccine I developed fever, chills, nausea, vomiting, myalgias, arthralgias which persisted for 36 hours. After 36 hours, the acute symptoms improved, but I have had persistent daily fever, sweats, chills. The fever has been as high as 102 degrees F orally. The night sweats have been extremely drenching. I also have had ongoing fatigue and have been unable to work or perform my usual activities.
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| 67 | 2021-01-24 | nausea | fever (100.4 - 100.9). chills, achy joints, fatigue, nausea |
| 67 | 2021-01-25 | diarrhea |
but tested covid positive; but tested covid positive; had sinus; a little diarrhea; cough; The initi...
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but tested covid positive; but tested covid positive; had sinus; a little diarrhea; cough; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 13Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer, reporting for herself. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration at the right arm at on 30Dec2020 11:15 at a single dose as the patient works for a medical retirement facility. Vaccination was done in a hospital. Medical history included was reported as none. The patient's concomitant medications were not reported. It was reported that the patient got her first shot on 30Dec2020, but tested COVID positive on 13Jan2021, had sinus, a little diarrhea, and cough. She was on quarantine with her husband as of today. She did not receive any other vaccines that day or 4 weeks prior. No history of any other vaccines or events. She was asking if she can take the second dose of the COVID vaccine. The patient underwent lab tests and procedures which included COVID virus: positive on 13Jan2021. The outcome of the events was unknown.
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| 67 | 2021-01-26 | diarrhea, vomiting |
7 hours after shot I had severe vomiting and diarrhea and chills; 7 hours after shot I had severe vo...
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7 hours after shot I had severe vomiting and diarrhea and chills; 7 hours after shot I had severe vomiting and diarrhea and chills; 7 hours after shot I had severe vomiting and diarrhea and chills; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly into the left arm on 11Jan2021 02:45 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly into the left arm on 21Dec2020 03:00 at a single dose for covid-19 immunization at the age of 67-year-old as well. On 11Jan2021 09:45, 7 hours after the shot she had severe vomiting, diarrhea and chills. The patient received no treatment for the events reported and was not pregnant at the time of administration of the vaccine. Outcome of the events recovered on an unspecified date in Jan2021. Information on lot number/batch number was requested.
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| 67 | 2021-01-27 | difficulty swallowing |
Because I have had allergic reactions to Naproxen and other drugs. I took a Zyrtec about 90 minutes...
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Because I have had allergic reactions to Naproxen and other drugs. I took a Zyrtec about 90 minutes before the vaccine. I was help in the waiting area for 30minutes and didn't have any adverse symptoms. it was about a hour after I returned home I felt my tongue swelling and was having issues with swallowing properly. I took another Zyrtec at that time and the issue resolved.
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| 67 | 2021-01-27 | nausea, vomiting |
Pt called the Covid Triage Line wanting to report adverse reactions to the Phizer Covid vaccine she ...
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Pt called the Covid Triage Line wanting to report adverse reactions to the Phizer Covid vaccine she received. Pt states she was Covid positive on 12/8/21 and received the Covid vaccine on 1/20/21. Later that day she reported feeling "woozy" and started to feel like she was "drunk" (pt states she has not had a drink since 2005). On 1/21/21 she felt "sick as a dog" and started "violently vomiting". She had a compazine suppository at home that she used which stopped the vomiting. She reports she remained extremely nauseated and fatigued for the next 24 hours. The nausea was only relieved when she would sleep or lie down flat. Pt states she slept the rest of the day on 1/21/21 to "about noon" on 1/22/21 and started to feel better during the late afternoon. She was able to eat dinner 1/22/21. Pt reports she still feels tired but that she is better on 1/23/21. Notified pt's PCP of events who followed up with pt with no further orders. Last note from PCP on 1/27/21. Spoke with pt 1/28/21 and pt states she remains without any further symptoms.
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| 67 | 2021-01-27 | nausea, vomiting |
SOB - wheezing nausea, vomiting - Anaphylaxis treatment Epinephrine, Tylenol, Duoneb, Decadron, Bena...
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SOB - wheezing nausea, vomiting - Anaphylaxis treatment Epinephrine, Tylenol, Duoneb, Decadron, Benadryl, Pepsid Nss
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| 67 | 2021-01-27 | nausea |
Nausea; muscle pain; joint pain; headache; tiredness; This is a spontaneous report from a contactabl...
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Nausea; muscle pain; joint pain; headache; tiredness; This is a spontaneous report from a contactable healthcare professional (patient). A 67-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248 and expiry date: Apr2021), via an unspecified route of administration on the left arm, on 12Jan2021 13:45 at a single dose for COVID-19 immunization. Medical history included high blood pressure; patient was not pregnant at time of vaccination. Concomitant medications were unspecified (received within 2 weeks of vaccination). The patient experienced nausea, muscle pain, joint pain, headache and tiredness on 13Jan2021 14:00. Treatment was not received for the events. Patient was recovering from the events. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
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| 67 | 2021-01-27 | nausea |
experience nausea; This is Spontaneous report from a contactable consumer (patient). A 67-year-old f...
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experience nausea; This is Spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3246), via an unspecified route of administration on left upper arm on 13Jan2021 09:30 at single dose COVID-19 vaccination. Medical history included high blood pressure and prediabetic. Patient reported that she has high blood pressure that she is on medication for. She said she takes Metformin twice a day, clarifying she is pre-diabetic according to her Hemoglobin A1C. Patient was on top of her bloodwork, saying she has her bloodwork done regularly. Reported patient's height was 4'11" or 5'. Concomitant medications included Metfiormin as patient is pre-diabetic. Reported she has had the flu and Shingles vaccines in the past, and never had any prior reactions to vaccines. No prior vaccinations (within 4 weeks). The patient had her first dose of the Pfizer COVID-19 Vaccine yesterday morning, 13Jan2021, at 9:30. She said she had some nausea last night. She said she woke up in the middle of the night with nausea. She said she woke up this morning and had nausea again, but ate something and got better. She said the nausea is like morning sickness, clarifying if she eats something the nausea goes away, but once her stomach is empty, the nausea comes back. She said she has not had a fever. She asked how long should she expect her nausea to last. The event did not require a visit to Emergency Room or Physician. The outcome of the event was not recovered.
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| 67 | 2021-01-28 | abdominal pain upper, nausea | Strong muscle cramps/spasms in stomach and upper abdomen, primarily on left side. Mild nausea |
| 67 | 2021-01-28 | abdominal pain, nausea, vomiting |
Pzfizer-BioNTech COVID-19 Vaccine EUA on 1/21/2021 (4 days after my first vaccine) at 10pm I experie...
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Pzfizer-BioNTech COVID-19 Vaccine EUA on 1/21/2021 (4 days after my first vaccine) at 10pm I experienced severe abdominal pains for 4 hours. This was then followed 30 minutes later by severe vomiting for 4 hours. At that time I was able to take a Zofran 8mg tablet to suppress the nausea. (A previous Zofran dose I had taken was immediately vomited up) Vomiting stopped. For 3 days after this I got mild stomach pains after I ate more than a few bites. I was fine after that.
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| 67 | 2021-01-28 | diarrhea |
This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient rec...
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This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) at left arm on 11Jan2021 12:00 PM at single dose for COVID-19 immunization. Medical history included high blood pressure. Patient is not pregnant. Other medications in two weeks included Amlodipine besylate and lisinopril and "altor". No other vaccine in four weeks. Patient used had known allergies to tetracycline. Patient experienced diarrhea on day 2, 3, 4 start on 12Jan2021. No treatment received for the events. Outcome of the event was unknown. No covid prior vaccination. No covid tested post vaccination.
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| 67 | 2021-01-28 | vomiting, nausea |
7:07 Started coughing then became nauseated proceeded to vomit. Nurse suggest after about 10 mins t...
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7:07 Started coughing then became nauseated proceeded to vomit. Nurse suggest after about 10 mins that she should take me to ED for Zofran. Upon getting to ED I was wheezing badly and trying to find inhaler in purse; wheezing and unable to catch a breath I was placed in a room, by then my body was turning red and wheezing worse. I was given epinephrine and prednisone immediately for anaphylaxis. They reacted immediately upon my arrival. Time I unsure. I just say thank God for them. Meds Given- Tylenol Duoneb, Decadron, Benadryl, Epinephrine, Pepcid, Nss
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| 67 | 2021-01-30 | vomiting, nausea | fever, chills, nausea, vomiting |
| 67 | 2021-01-30 | vomiting |
Shot administered 6:08pm. About 6:18pm I felt very tired and wanted to close my eyes. I told my husb...
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Shot administered 6:08pm. About 6:18pm I felt very tired and wanted to close my eyes. I told my husband 'I don't feel well'. Immediately my eyes rolled back and convulsions started. Then I passed out. EMTs were called over to car and started to administer oxygen. I woke up about 6:30pm cognizant of surroundings. BP was normal. No fever, no rash, no chills. I was just tired. Then 2 hours of vomiting started. Last vomit about 8:15pm in ambulance. EMT unable to administer IV. After waiting in ER waiting room for 45+ minutes, a bed was available (around 9pm). ER doctor gave me ondansetron ODT 4mg Once. Released at 10:12pm to go home. Next 3 days symptoms of lightheadedness and dull headache.
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| 67 | 2021-01-31 | constipation |
day 13, 14, 15 mild headache, feel like early onset of head cold: low energy, heavy chest; constipat...
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day 13, 14, 15 mild headache, feel like early onset of head cold: low energy, heavy chest; constipated with only small soft BM after product use; self care
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| 67 | 2021-01-31 | GERD |
Severe chest pain, pain in jaw, brow bones and headache (may have been due to GERD- acid reflux dise...
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Severe chest pain, pain in jaw, brow bones and headache (may have been due to GERD- acid reflux disease), symptoms started at 11:30PM while in bed and lasted 1-2 hours; sudden onset and dissipation
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| 67 | 2021-02-01 | diarrhea, nausea |
Itching at injection site within 3 minutes or less from time of injection, After two to three minute...
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Itching at injection site within 3 minutes or less from time of injection, After two to three minutes of the itching episode, heart racing followed by palpitations. Followed by chest tightness over heart area. Followed by shaking in upper torso and arms and hands. Became nauseous followed by weakness and a need of a wheel chair to get to my car. A few hours after arriving at home, itching started all over my body and nausea persisted through the night. Itching became stronger. The morning after the shot explosive diarrhea. Fatigue, chills and hot and cold feelings the following day as well as itching persisted. Now, two days later, itching remains with intermittent mild chest tightness which is abating and taking zytrec for the itching
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| 67 | 2021-02-01 | difficulty swallowing |
glands/throat swollen; glands/throat swollen; bad problem swallowing.; face started to get puffy; Af...
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glands/throat swollen; glands/throat swollen; bad problem swallowing.; face started to get puffy; After 15 minutes, felt light headed; throat felt tight; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: BL1284), via an unspecified route of administration on 14Jan2021 09:00, at right arm, at single dose for covid-19 immunization. Medical history included Allergies chronic and known allergies to Shellfish, papaya, cats, latex, wool, pollens, mold. Concomitant medication included azelastine. After 15 minutes vaccination, the patient felt lightheaded and throat felt tight. Took an Allegra and seemed better after about 30 minutes. Took a benedryl that afternoon and night, and next day (Friday, 15Jan2021) seemed ok. Took benedryl on Friday night because face started to get puffy. Then awoke at 3:50 am Saturday (16Jan2021) morning and glands/throat swollen and was having bad problem swallowing. Treatment steroid was received to get selling down. The outcome of the events lightheaded and throat felt tight was recovered on 15Jan2021. The outcome of the other events was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
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| 67 | 2021-02-01 | vomiting, nausea |
nausea; vomiting; rigors; temperature greater than 100 degrees topical; headache; muscle ache; This ...
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nausea; vomiting; rigors; temperature greater than 100 degrees topical; headache; muscle ache; This is a spontaneous report from a contactable health care professional nurse, the patient. A 67-years-old non-pregnant female patient (nurse) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot Number: EK9231,), intramuscular in the left arm on 07Jan2021 16:00 as a single dose, for COVID-19 vaccination. Medical history included gastrooesophageal reflux disease. Concomitant medication included diltiazem (DILTIAZEM). Patient has no known allergies. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number EH9899, on 18Dec2020; 16:00, Intramuscular, right arm,. On 08Jan2021 at 04:00 the patient experienced nausea, vomiting, rigors, temperature greater than 100 degrees topical, headache, muscle ache. The events resulted in a Physician office visit. Lab tests included body temperature: greater than 100 degrees on 08Jan2021. Treatment given include zofran, APAP, fluids, and rest. The clinical outcome of nausea, vomiting, rigors, temperature greater than 100 degrees topical, headache, muscle ache was recovering.
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| 67 | 2021-02-02 | nausea |
Within 15-minutes of vaccination, the patient reported a gradual onset of nausea. Patient was manage...
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Within 15-minutes of vaccination, the patient reported a gradual onset of nausea. Patient was managed on-site by EMS.
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| 67 | 2021-02-03 | diarrhea | got covid jan 3,2021 |
| 67 | 2021-02-03 | nausea |
one of the nurses at the outpatient clinic where she works was positive for covid; Nausea; she start...
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one of the nurses at the outpatient clinic where she works was positive for covid; Nausea; she started feeling a little warm; Low grade fever; Chills; This is a spontaneous report from a contactable nurse reporting for herself. A 67-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302), intramuscularly on 19Jan2021 11:03 on right arm at single dose for COVID-19 immunization. Vaccination Facility Type was at Clinic. Medical history included just had rotator cuff repair surgery last Thursday (11Jan2021), pain, muscle relaxer. Concomitant medications included acetaminophen; hydrocodone as pain medicine, methocarbamol as muscle relaxer. Historical Vaccine included first dose of BNT162B2 (Lot number: EK9231) intramuscularly on 28Dec2020 at 9:52 am for COVID-19 immunization on right arm and experienced right arm soreness at the injection site. It was reported that last night (19Jan2021) she had a low grade fever and chills, then it went away, she was not having the chills earlier today and the fever went away. The fever had come back and she was chilled even though it was hot. She tested negative for coronavirus that Monday (08Jan2021) prior to the surgery. She was being told that one of the nurses at the outpatient clinic where she worked was positive for covid. She clarified that the fever and the chills go together and started last night. The fever did get better and she was not feeling feverish or chilled during the day. About 2 or 3 hours ago (20Jan2021) she started feeling a little warm, nauseated and she checked her temperature 30 minutes ago and it was 99.4. She always run low and did not have a fever. No treatment received for all events. The outcome of event low grade fever was resolving, outcome of events chills and nauseated were not resolved, outcome of other events were unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events low grade fever, chills and nausea cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 67 | 2021-02-03 | nausea |
Within 15-minutes of vaccination, the patient reported feeling nauseous. EMS monitored the patient's...
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Within 15-minutes of vaccination, the patient reported feeling nauseous. EMS monitored the patient's condition on-site.
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| 67 | 2021-02-05 | abdominal pain, diarrhea, nausea |
Within an hour, strong abdominal cramping, diarrhea, nausea. Mouth very dry, choking sensation which...
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Within an hour, strong abdominal cramping, diarrhea, nausea. Mouth very dry, choking sensation which resolved quickly. The abdominal pain was very uncomfortable, and that along with diarrhea and nausea lasted nearly a week.
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| 67 | 2021-02-07 | diarrhea, nausea, vomiting, abdominal pain |
Medical history included systemic lupus; Medical history included systemic lupus; Fever; Vomiting; D...
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Medical history included systemic lupus; Medical history included systemic lupus; Fever; Vomiting; Diarrhea; Abdominal pain; Joint/muscle pain; Joint/muscle pain; Nausea; Fatigue; Severe headache; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL3249, via an unspecified route of administration in the right arm on 15Jan2021 13:00 at SINGLE DOSE (first dose) for COVID-19 immunization. Medical history included systemic lupus, "hypothyroid", Leiden Factor V. Patient's known allergies: penicillin, erythromycin and tetracycline. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medications included hydroxychloroquine, clopidogrel bisulfate (PLAVIX), acetylsalicylic acid (ASPIRIN), fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN). The patient previously took erythromycin and experienced drug hypersensitivity, tetracycline and experienced drug hypersensitivity. On 15Jan2021 16:00, the patient experienced fever, vomiting, diarrhea, abdominal pain, joint/muscle pain, nausea, fatigue, severe headache and sore arm. Outcome of events was fever, vomiting, diarrhea, abdominal pain, joint/muscle pain, nausea, fatigue, severe headache and sore arm not recovered. Outcome of the other events was unknown. Patient did not receive any treatment for the events. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
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| 67 | 2021-02-07 | diarrhea |
terrible case of diarrhea; arm is sore; This is a spontaneous report from a contactable consumer (pa...
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terrible case of diarrhea; arm is sore; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3749), intramuscular on 20Jan2021 15:30 at a single dose on left arm for COVID-19 immunization. Medical history included ongoing COPD, diagnosed probably 7 years ago. There were no concomitant medications. The patient's arm began to get sore the day after receiving the vaccine, 21Jan2021. She had a CAT scan earlier last week, but this was prior to the vaccine. She had the terrible case of diarrhea this morning, 22Jan2021, but she hasn't had diarrhea since then. She got up this morning. She was feeling fine, she drank 2 cups of coffee. She was pouring herself a cup of orange juice, and she had a terrible case of diarrhea. The outcome of the event diarrhea was unknown, arm is sore was recovering. Vaccination Facility Type was Physician's office. Adverse events did not require a visit to Emergency Room nor Physician Office. No prior vaccinations (within 4 weeks). No adverse events following prior vaccinations.
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| 67 | 2021-02-08 | GERD |
Patient complained of GERD going from her epigastric area through to her back. Vital signs monitored...
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Patient complained of GERD going from her epigastric area through to her back. Vital signs monitored. Symptoms resulolved within a few minutes. Pt states that she had not eaten lunch and this was not an uncommon thing for her to experience GERD, but had never experienced with vaccination. Monitored patient for 30 minutes post vaccination. Telephoned patient at home at 1822. She is feeling well with no further issues.
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| 67 | 2021-02-08 | nausea |
Nausea, a bit of headache immediately after receiving vaccine. The next day extreme fatigue, some pe...
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Nausea, a bit of headache immediately after receiving vaccine. The next day extreme fatigue, some periods of weakness, muscle ache, joint ache, a bit of nausea and headache; soreness, swelling, and redness at injection site; intermittent itching at injection site and upper body
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| 67 | 2021-02-09 | diarrhea |
Got a bumpy itchy rash on both legs which is still present; sweating; arm began to hurt then throb a...
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Got a bumpy itchy rash on both legs which is still present; sweating; arm began to hurt then throb and go numb a bit; arm began to hurt then throb and go numb a bit; The patient was cold; clammy; the first blood pressure was 90 over something/second blood pressure was 70 over 40 something; diarrhea; tired; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: 3247), via an unspecified route of administration in the left arm on 18Jan2021 10:00 at a single dose for COVID-19 immunization. The patient's medical history was none. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 18Jan2021 10:10, the patient's arm began to hurt then throb and go numb a bit. On 18Jan2021 10:15, the patient started sweating. She stood up to try and feel better. The patient's husband called the nurse over and they called the paramedics because they said the patient was cold, clammy, and still sweating. The patient sat down again and they put leads on me to check her heart rate, blood pressure (BP), and oxygen on 18Jan2021. Her heart rate and oxygen were fine but the first BP was 90 over something. A few minutes later, she closed her eyes and could have fallen asleep right there. Her second BP was 70 over 40 something. She opened up her eyes and tried to stand up again. After a few more minutes, her BP came up and was OK. They refused an ambulance and went home. She had diarrhea at home on 18Jan2021. She ate, walked and felt better. She just experienced the normal tired and hurt arm in the afternoon on 18Jan2021. She rested the balance of the day. On Wednesday (20Jan2021), she got a bumpy itchy rash on both legs which is still present but with cream, it was OK. No treatment was received for the adverse events. Outcome of the "the first blood pressure was 90 over something/second blood pressure was 70 over 40 something" was recovered on 18Jan2021 and of the remaining events was recovered on Jan2021.
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| 67 | 2021-02-10 | abdominal pain |
12/22 arm soreness, 12/23 headache, dizziness, body ache, abdominal pain. symptoms lasted until 1/2/...
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12/22 arm soreness, 12/23 headache, dizziness, body ache, abdominal pain. symptoms lasted until 1/2/21. Ibprofen and increased fluid whiched helped alliviate some of the symptoms
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| 67 | 2021-02-10 | nausea, retching |
The same day as receiving the vaccine, I started getting nervous and restless around 11pm after I we...
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The same day as receiving the vaccine, I started getting nervous and restless around 11pm after I went to bed. I started having generalized pain, all my muscles became achy and my R arm was so sore I could not move it. About 1 am the next morning, I became nauseated and retching. I stared sweating and chilling, my body was shaking so bad I could not hold my thermometer. That lasted possibly 5 minutes, fever 100.8. Episodes of sweating alternating with cold chills occurred the remainder of the night. Exhaustion set in and I could not get out of bed. I was on bedrest all morning and I began to feel better around 4-5pm the next day.
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| 67 | 2021-02-10 | nausea |
Headache, nausea, fatigue, generalized body aches lasting for 7 days. Symptoms mostly resolved after...
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Headache, nausea, fatigue, generalized body aches lasting for 7 days. Symptoms mostly resolved after 7 days, still feeling fatigued
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| 67 | 2021-02-11 | vomiting, diarrhea | Diarrhea, vomiting, rash, mild hives, chills, episode of delirium |
| 67 | 2021-02-14 | decreased appetite, nausea | Myalgias, fatigue, headache, weakness, nausea, chills, decreased appetite and easy bruising. |
| 67 | 2021-02-14 | nausea, diarrhea |
8 hours post the vaccine the pt experienced severe nausea, vomiting, diarrhea, fever , chills and ac...
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8 hours post the vaccine the pt experienced severe nausea, vomiting, diarrhea, fever , chills and aches
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| 67 | 2021-02-14 | nausea, vomiting |
During screening, patient stated she has tested positive while in Ohio in early January, had symptom...
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During screening, patient stated she has tested positive while in Ohio in early January, had symptoms of headaches and loss of taste. Upon returning to CA, tested positive again Feb. 1st and was diagnosed as a "long-hauler". Denies any symptoms at this time except for loss of taste. Approximately 10 minutes after injection in monitoring area, patient began complaining of dizziness, headache, nausea and feeling hot. After about 10 minutes more, patient then began complaining about chills and stated she felt the need to throw up, spit up a small amount of sputum. Offered to call for ambulance, patient stated she did not want to go to the hospital, just wanted to go home. Approximately 10 minutes later, patient felt stable enough move her to a wheelchair and assisted outside so that she could remove her mask. 02 applied at 2L via nasal cannula, patient stated immediate relief of nausea and dizziness once outside. After another 10 minutes, patient stated headache was now a dull ache and she felt well enough to go home. Spouse provided nurse call number for local hospital, patient transported to vehicle via wheelchair.
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| 67 | 2021-02-14 | nausea, vomiting |
Saturday, 2/13/21 7;00 am. chills, fatigue, nausea 11:00 am-3:00pm, vomiting 3 times, fever of 10...
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Saturday, 2/13/21 7;00 am. chills, fatigue, nausea 11:00 am-3:00pm, vomiting 3 times, fever of 100 degrees ( normal temperature is 97.5) 6pm - 6:00 am. Fever spiking to 102.7 throughout night Sunday, 2/14/21 Fatigue and weakness. Increased pain at injection sight.
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| 67 | 2021-02-14 | nausea | Nausea, fever |
| 67 | 2021-02-14 | nausea | intermittent nausea |
| 67 | 2021-02-15 | nausea |
Client c/of nausea and dizziness. states that she hand's had anything to eat since am. client star...
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Client c/of nausea and dizziness. states that she hand's had anything to eat since am. client started having symptom after getting out of car to walk her dog. Pt voice that she suffers from panic disorder and was having an episode. Pt assessed, vital signs are as follows: BP 130/84, HR 80, O2 97%. Client cleared to go home after stating she felt better.
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| 67 | 2021-02-16 | difficulty swallowing, nausea |
Within 15-minutes of vaccination, the patient reported nausea, pruritus on bilateral feet, her throa...
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Within 15-minutes of vaccination, the patient reported nausea, pruritus on bilateral feet, her throat "feeling itchy and weird", and that it was hard to swallow. EMS evaluated patient on-site and was found to be hypertensive (182/133). Administered 4mg Ondansetron PO and 50mg Benadryl IV. Patient was transported to ED for evaluation. In the ED, patient was hypertensive (191/85) but noted feeling better after Benadryl IV. No evidence of worsening allergic reaction or respiratory distress. Patient was discharged from ED with instructions to follow-up with PCP.
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| 67 | 2021-02-16 | nausea |
One and a half hours after I received my injection, while driving home, my mouth, lips and face bega...
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One and a half hours after I received my injection, while driving home, my mouth, lips and face began to tingle. This lasted for almost two hours. I experienced some brief tingling of the skin on my chest as well and on the skin of my upper thighs. I did not have trouble breathing, and did not develop a rash anywhere on my body. The tingling remained localized to my face and the upper part of my mouth. There was no swelling of my lips or redness of my lips. Immediately after I received my injection I briefly felt the slightest bit of light headedness, but this resolved before I left the vaccination site. I felt tired later in the evening and then began to experience headache and nausea, the typical side effects that I had anticipated and previously heard about.
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| 67 | 2021-02-16 | nausea |
Vaccinated 2/11 and symptoms started 2/13 at noon. Sudden bronchial spasms, obstructive apnea, cyano...
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Vaccinated 2/11 and symptoms started 2/13 at noon. Sudden bronchial spasms, obstructive apnea, cyanosis. EMS gave a breathing tx, O2 sats WNL. Declined transfer to hospital at that time for fear of Covid. Client exhibited confusion, oriented x 0, short term memory loss. Bronchial spasms resumed, EMS again called, transported via EMS to MC. Diagnosed with transient global amenesia and hypercapnia. Client was transported to MC for CT and MRI for r/o stroke. Stroke was ruled out. Client with c/o severe H/A, nausea, dizziness, myoclonic seizures. Severe h/a which lasted 4 days. Still experiences mild memory loss, confusion, and h/a are becoming less severe. Client states that sensory processing is slowed
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| 67 | 2021-02-21 | nausea, abdominal pain upper |
34 hours (2:00 am on 2/19/21) after injection I woke up with stomaching cramping and nasuea. At 3:00...
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34 hours (2:00 am on 2/19/21) after injection I woke up with stomaching cramping and nasuea. At 3:00 a.m. I was dizzy and had uncontrollable shaking over entire body for approximately 45 minutes. The nausea continued throughout the entire day on 2/19/21. I contacted the Department of Health today, but whomever I spoke to did not seem interesed in hearing about it and did not ask any questions or for any information.
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| 67 | 2021-02-21 | nausea, diarrhea |
Too dizzy to pen eyes, nauseous, diarrhea, headache, chills, sweating, duration about 6 hours, recov...
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Too dizzy to pen eyes, nauseous, diarrhea, headache, chills, sweating, duration about 6 hours, recovery within 10 hours
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| 67 | 2021-02-23 | difficulty swallowing |
Pt. from tent 16 in observation lane complained of fluttery chest, difficulty swallowing, headache, ...
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Pt. from tent 16 in observation lane complained of fluttery chest, difficulty swallowing, headache, dry mouth. Paramedics assessed pt. once symptoms subsided paramedic released pt. to leave.
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| 67 | 2021-02-23 | burping |
2/7: By 7:00 pm, I had fever which rose to 102+ before midnight. 2/8: Low-grade fever, flu-like fee...
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2/7: By 7:00 pm, I had fever which rose to 102+ before midnight. 2/8: Low-grade fever, flu-like feeling, "heavy head", lethargic 2/9-2/10: Pretty much back to normal with the addition of an injection site "hot spot"- raised, rashy and feverish 2/11: Began feeling general malaise in the afternoon. Low grade fever, pain behind collarbone on both sides. By 7pm, severe chills. 2/12: Called PCP and advised of symptoms. Went and got a Covid19 PCR test just in case. Negative 2/13-2/15: Still had low-grade fever (usually around 100*) which often didn't present until 2pm and then stayed until bedtime. Glands became swollen, bad night sweats. Pain behind collarbone worse when sneezing, coughing, yawning, burping, etc. Additional information for Item 18: Almost like a "catch" rather than constant pain. 2/16: Went to local medical center for drive-thru rapid Covid 19 and flu test. Both came back negative as did the PCR Covid test they also ran. 2/17-2/20: Symptoms pretty much the same....no fever in the am and thought I was finally getting better, then it would spike again around 1:00-2:00. Never over 101*. On the morning of 2/21, the "catch" around the collarbone had moved down to the bottom of my ribcage. 2/22: Contacted PCP again and made appointment for bloodwork, chest x-ray, and further tests. "Sick and tired of feeling sick and tired!"
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| 67 | 2021-02-23 | nausea |
nausea; felt tired; Rash is red and she can feel bumps; rash is red and she can feel bumps; pain at ...
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nausea; felt tired; Rash is red and she can feel bumps; rash is red and she can feel bumps; pain at the injection site; itching going on in my face, my left arm, in the elbow / stomach about 2 inches to the left where they made the incision for the cancer removal; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL9269), via an unspecified route of administration into left arm on 06Feb2021 (at the age of 67-years) as a single dose for COVID-19 immunization. Medical history included allergic to peanuts, allergic to Penicillin, cancer and hysterectomy. There were no concomitant medications. The patient previously took vancomycin, cefalexin (KEFLEX) and zelnorm and was allergic. On 06Feb2021, the patient had pain at the injection site, but that was gone now. She also experienced rash, which was elaborated as an itch, like a rash that started since she got the shot. She had the itching rash going on into her face, left arm, the elbow, and also 2 inches from naval on the left side where she had incision from cancer removal, hysterectomy. The rash was started in the area of the hysterectomy. The patient elaborated that the rash was red and she can feel bumps. The patient was taking diphenhydramine hydrochloride (BENADRYL) which usually stop the itching. Last night 06Feb2021, the back of her left elbow and her face started itching as well and at 23:30 the patient experienced nausea and felt tired. The patient is scheduled for second dose on 27Feb2021. The clinical outcome of event rash is red and she can feel bumps was not recovered. The outcome of pain at the injection site was recovered in Feb2021. The clinical outcome of other events was unknown.
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| 67 | 2021-02-24 | nausea, vomiting |
Patient woke up at 0200 with the room spinning, she felt dizzy, and nauseated. Was able to get into ...
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Patient woke up at 0200 with the room spinning, she felt dizzy, and nauseated. Was able to get into the rest room where she vomited. Patient received meclizine and ondansetron in the ED. Neurology consult requested stroke/TIA work up.
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| 67 | 2021-02-24 | vomiting, difficulty swallowing | vomiting, chest tigthness and shortness of breath, tongue swelling and difficulty swallowing |
| 67 | 2021-02-25 | abdominal pain upper |
Chills, low-grade fever (99 - 100), headache, body ache, fatigue - lasted for two days, then lifted....
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Chills, low-grade fever (99 - 100), headache, body ache, fatigue - lasted for two days, then lifted. One day of feeling fine, then the next day starting getting stomach cramps in waves, then more chills and fatigue, which lasted through that day; by afternoon of the next day I felt fine.
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| 67 | 2021-02-25 | decreased appetite |
Muscle aches, chills and severe joint pain 9:05PM Treatment: went to bed at 10:00 P Following day 2/...
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Muscle aches, chills and severe joint pain 9:05PM Treatment: went to bed at 10:00 P Following day 2/25/2021: 7:45 AM extreme fatigue, loss of appetite, taste buds off Treatment: naps, fluids 02/25/2021 9:00PM mild muscle aches and joint pain
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| 67 | 2021-02-25 | diarrhea |
sore arm; diarrhea; bad taste in her mouth/can taste vaccine in her mouth and throat; This is a spon...
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sore arm; diarrhea; bad taste in her mouth/can taste vaccine in her mouth and throat; This is a spontaneous report from a contactable consumer (patient). This 67-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EL1283), via an unspecified route of administration on 26Jan2021 09:55 at single dose in the left arm for COVID-19 vaccination. Medical history and concomitant medications were none. Patient got her first injection of the COVID-19 vaccine on 26Jan2021 at 09:55AM in her left arm. Patient said that the diarrhea just started on 26Jan2021, she had tried calling earlier and had to hang up because of it, maybe because she was nervous. Patient said that she tasted the vaccine constantly, she has been experiencing a bad taste in her mouth, she couldn't stand the taste. Patient couldn't get rid of the taste. She said beforehand she was scared of anaphylactic shock, but she was having the taste in her mouth and diarrhea. She said she had the taste of the vaccine in her mouth and throat on 26Jan2021. She said that everything that she eats she is trying to get taste out of her throat. Patient has done no treatment yet for the diarrhea or the taste in her mouth. She said that her arm didn't hurt afterwards and she didn't feel the shot, and now she can't touch her arm without it hurting though she has been moving her arm a lot. She said she knew that from the flu shot, but that never hurt her, this thing was sore (sore arm) on 26Jan2021. She said she wasn't worried about that though, she just wanted to know if the taste would go away, and if it was normal. She said that there was nothing that said anything about diarrhea either, and she was not sick, she didn't feel sick, there was just the taste. Outcome of the events was unknown.
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| 67 | 2021-02-26 | nausea |
Fever, aching, (severe) chills, (a little) nausea, unable to get out of bed for 30 hrs, symptoms con...
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Fever, aching, (severe) chills, (a little) nausea, unable to get out of bed for 30 hrs, symptoms continued for 48 hrs toatal.
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| 67 | 2021-02-27 | indigestion |
Did not report on check in yesterday because I didn't think there was a correlation. I developed s...
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Did not report on check in yesterday because I didn't think there was a correlation. I developed severe persistent heartburn 2.5 weeks after second dose. I considered this as more coincidence (although I have never had severe heartburn except once related to NSAID use) given the timing (2.5 weeks after vaccine) and that I had not seen this listed as a potential side effect. It then dawned on me that if no one reported for the same reasons you would never know that there is in fact a correlation so I am deciding to report. It may be worthless data but it may also be relevant.
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| 67 | 2021-02-27 | nausea | erythema-face, angioedema-hands, lips, nausea |
| 67 | 2021-02-27 | nausea |
Started with Chills approx 8 pm same day as vaccine given. Developed general weakness/tiredness, fe...
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Started with Chills approx 8 pm same day as vaccine given. Developed general weakness/tiredness, fever, headache, muscle/joint pain, nausea, dizziness with made it difficult to walk to the bathroom d/t the dizziness, general unwell feeling. I took tylenol. I applied ice packs to my neck and core body area. I was confined to the bed until Friday apprx 11:00 am until I could get up. I continue to feel "funny" in the head at times. I did not seek any Dr or hospital visit.
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| 67 | 2021-02-28 | diarrhea |
Loose bowels 2nd day after shot; Rapid heart beat for about an hour second day, but could be thyroid...
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Loose bowels 2nd day after shot; Rapid heart beat for about an hour second day, but could be thyroid as well; Rapid heart beat for about an hour second day, but could be thyroid as well; Sore arm, not severe; Lethargic for a day; This is a spontaneous report from a contactable other health professional, the patient. This 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1, single dose via an unspecified route of administration on 26Jan2021 at 09:00 AM in the left arm (at the age of 67 years-old) for COVID-19 vaccination. Medical history included hypothyroidism, autoimmune disease, allergies to penicillin and many foods. Concomitant medications included etanercept (ENBREL), levothyroxine sodium (SYNTHROID), liothyronine sodium (CYTOMEL) and losartan potassium (LOSARTIN). The patient receive did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jan2021 at 09:00 AM, the patient experienced sore arm, not severe and was lethargic for a day. On 27Jan2021, the patient had loose bowels the second day after the shot and rapid heart beat for about an hour second day, but could be thyroid as well. No treatment was received for events, sore arm, lethargic, loose bowels, rapid heart beat and thyroid. The events were reported as non-serious. The clinical outcome of sore arm, lethargic, loose bowels, rapid heart beat and thyroid was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has not been tested for COVID-19 since the vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 67 | 2021-02-28 | retching |
Approximately 5-10 minutes after receiving the vaccine, patient began sweating, feeling dizzy and dr...
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Approximately 5-10 minutes after receiving the vaccine, patient began sweating, feeling dizzy and dry heaving. BP was normal as well as HR. This has happened before with vaccines and other needle sticks like blood draws. Patient was given and ice pack to help her cool down and after about 10-15 more minutes, patient was calm enough to leave the vaccine observation area.
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| 67 | 2021-03-01 | decreased appetite |
Day 1: uncontrollable coughing spasms for several minutes, piercing joint pain in left shoulder cap...
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Day 1: uncontrollable coughing spasms for several minutes, piercing joint pain in left shoulder capsule and right ankle, 101 degree fever lasting 6 hours Day 2: chills, exhaustion/weakness, inability to concentrate, lack of appetite Day 3 &4: waves of muscle aches and exhaustion
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| 67 | 2021-03-01 | nausea | lightheaded, dizziness and nausea. Evaluated by EMS-Cleared |
| 67 | 2021-03-02 | nausea, diarrhea | Chills, fever, body aches, nausea, diarrhea, dizziness, feels like I have the flu |
| 67 | 2021-03-02 | nausea, vomiting |
Migraines 3 days, vomiting 1day, nausea 4 days. Muscle aches 4 days, joint pain 5 days. Exhaustion 5...
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Migraines 3 days, vomiting 1day, nausea 4 days. Muscle aches 4 days, joint pain 5 days. Exhaustion 5 days
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| 67 | 2021-03-02 | nausea |
injection site pain; headache; joint pain; nausea; feeling unwell; tiredness/tired; swollen lymph no...
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injection site pain; headache; joint pain; nausea; feeling unwell; tiredness/tired; swollen lymph nodes under left arm; achy; This is a spontaneous report from a contactable consumer reporting for herself. This 67-year-old non-pregnant female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 30Jan2021 at 09:30 AM, in left arm, for COVID-19 immunisation. Medical history included allergies to sulfa and COVID before vaccination. Concomitant medications included calcium, glucosamine/chondroitin and unspecified multivitamin. On 30Jan2021 at 16:00 the patient experienced injection site pain, headache, joint pain, nausea, feeling unwell, tiredness, swollen lymph nodes under left arm and achy. The events got progressively worse the following day. On 01Feb2021 the patient was too tired and achy to go to work. The events did not require any treatment and were resolving at the time of report. COVID was not tested post vaccination. No follow-up attempts are possible. Information on lot/batch cannot be obtained. No further information is expected.
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| 67 | 2021-03-02 | nausea |
Fever to 102, chills, body aches. Palpitations headache, nausea everything started the day after sym...
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Fever to 102, chills, body aches. Palpitations headache, nausea everything started the day after symptoms lasted until 3/2/2021
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| 67 | 2021-03-02 | vomiting |
throat is still sore; Vomiting; Migraine; This is a spontaneous report from a contactable consumer (...
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throat is still sore; Vomiting; Migraine; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261 and expiry date: unknown) via an unspecified route of administration on the left deltoid, on 27Jan2021 10:00 at a single dose for COVID-19 immunization. Medical history included ongoing type 2 diabetic for at least 15 years. There were no concomitant medications and no prior vaccinations within 4 weeks. On 28Jan2021, patient got a migraine and on 29Jan2021, the vomiting started which was so bad her throat was still sore. The migraine resolved as of the morning of 01Feb2021. The vomiting lasted 3-4 hours and resolved the same day (29Jan2021). It was done at a clinic at a local church. There were no treatment, she just waited it out and rehydrated. Outcome of the event throat was still sore was not recovered.
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| 67 | 2021-03-03 | diarrhea |
Immediately after medicine went in my arm I felt a warm flush from my neck all the way to my toes (t...
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Immediately after medicine went in my arm I felt a warm flush from my neck all the way to my toes (the same as when I have had radioactive dye), during my 15 minutes of observation my hands and feet were cold and sweaty and I felt a little shaky. I waited 20 minutes and went to the restroom and had diarrhea (very rare for me). I went to my car and looked in the mirror and my face was bright red and the whites of my eyes were red and my eyes were glassy. I went back in to the observation area and was given oral Benadryl. and monitored for 45 minutes. Right after I took the Benadryl my throat felt itchy (not sore - itchy). My blood pressure was 157/62 when I first sat down but came down to 130/ 60 by the time I was sent home. My bp is normally about 106/60. I was really tired at home for the rest of the day so went to be early. The next day I felt fine and my arm was only slightly sore. The doctor at the immunization clinic told me not to get the 2nd shot. I called my GP, and he too told me not to get the 2nd COVID shot and wait until more information has come out about adverse reactions to the vaccine. I did not have any difficulty breathing. I don 't know if the redness on my face went down my neck to my chest. I didn't look. I did not have a fever.
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| 67 | 2021-03-03 | nausea |
Shot in left arm. No side effects until three days later began having nausea, fever, chills, aches....
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Shot in left arm. No side effects until three days later began having nausea, fever, chills, aches. Next day noticed heat, redness, increased swelling, tenderness of RIGHT arm that has Lymphedema. Called doctor today and was prescribed Keflex 500 4x a day for 7 days for suspected cellulitis.
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| 67 | 2021-03-03 | vomiting, nausea |
Chills; Headache; Severe sweats; Nausea; Runny nose; Fever; Vomiting; It was positive for Covid and ...
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Chills; Headache; Severe sweats; Nausea; Runny nose; Fever; Vomiting; It was positive for Covid and negative for the antibodies the Nurse told me; It was positive for Covid and negative for the antibodies the Nurse told me; It was positive for Covid and negative for the antibodies the Nurse told me; This is a spontaneous report from a contactable consumer. A 66-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 at single dose for covid-19 immunisation. Medical history included diabetes mellitus. The patient's concomitant medications were not reported. The patient experienced positive for covid and negative for the antibodies on 02Feb2021, chills, headache, severe sweats, nausea, runny nose, fever, vomiting on an unspecified date. The outcome of events was unknown. Information about lot/batch number has been requested.
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| 67 | 2021-03-04 | decreased appetite |
Woke up feeling fine, a few hours later started with fatigue, extreme chills, achy, and my arm was v...
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Woke up feeling fine, a few hours later started with fatigue, extreme chills, achy, and my arm was very sore swollen some at injection site, however, I had swelling under my armpit that was very tender and sore to touch. These symptoms lasted for 2 days, the armpit tenderness lasted for 4 days. I could t keep my blood sugar levels low, as they remained high almost 400. I was taking additional insulin to try and bring it down and I wasn?t eating.
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| 67 | 2021-03-04 | diarrhea, nausea |
Friday around 5:30pm a headache began and then tongue swelling began around midnight Then the sw...
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Friday around 5:30pm a headache began and then tongue swelling began around midnight Then the swelling of tongue went away around 3pm on Saturday afternoon. On Saturday The nausea and diarrhea started around 7:30am and subsided by 9am. The headache went away by Sunday afternoon.
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| 67 | 2021-03-04 | vomiting, abdominal pain, nausea, abdominal distension |
elevated transaminase measurement; Severe abdomen pain; abdomen swelling; chills; nausea; vomiting; ...
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elevated transaminase measurement; Severe abdomen pain; abdomen swelling; chills; nausea; vomiting; This is a spontaneous report from a contactable consumer. A 67-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: el 3247), via an unspecified route of administration on the left arm on 28Jan2021 10:15 at a single dose (at the age of 67-years-old) for COVID-19 immunization. The patient was administered in a public health clinic/administration facility. Medical history included asthma, diabetes, high blood pressure and anxiety. The patient had unspecified concomitant therapy. The patient preciously took enalapril and sulfur and experienced drug allergies: "Allergies to medications, food, or other products: Sulfur, Enalapril". The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jan2021 at 21:30, the patient experienced severe abdomen pain, abdomen swelling, chills, nausea, vomiting and elevated transaminase measurement. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received unspecified treatment for the adverse events. The patient underwent lab tests and procedures in 2021 which included CT scan, comprehensive metabolic, Random amplification of polymorphic DNA (Rapd) and ultrasound all with unknown results; on 30Jan2021 elevated transaminase; and on 31Jan2021 a negative nasal swab (SARS-CoV-2 test). The events were considered non-serious by the reporter: not resulted in death, not life threatening, did not cause or prolong hospital, not disabling/incapacitating and not a congenital anomaly/birth defect. The patient has not recovered from the events.
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| 67 | 2021-03-04 | vomiting, nausea |
Severe headache, fever high at 101, aches in joints, nausea and vomiting,fatigue. Started at about 1...
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Severe headache, fever high at 101, aches in joints, nausea and vomiting,fatigue. Started at about 1 am on 3/5/21. Fever has dropped to 100 as of 4 pm. Severe headache persists. Advil every 6-7 hours, fluids regularly
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| 67 | 2021-03-06 | nausea |
Pfizer, pain in arm around the injection site, down into left breast, nausea could not sleep on the ...
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Pfizer, pain in arm around the injection site, down into left breast, nausea could not sleep on the side of injection too painful
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| 67 | 2021-03-06 | vomiting, nausea |
Severe muscle and joint pain Severe body aches Skin pain Severe headache Nausea Vomiting Fever S...
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Severe muscle and joint pain Severe body aches Skin pain Severe headache Nausea Vomiting Fever Severe chills Left arm pain Injection site swelling, redness hives around left upper arm Left axillary lymph node swelling
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| 67 | 2021-03-06 | vomiting | Body ache, chills, throw-up, felt like a case of the flu |
| 67 | 2021-03-08 | decreased appetite |
First 48 hours reports felt fine. Sunday am felt achy and tired. Took advil and aspirin. Reports the...
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First 48 hours reports felt fine. Sunday am felt achy and tired. Took advil and aspirin. Reports the next 8 days she felt sleepy and achy. Reports felt ok couple of days. Friday 3/5/2021 she had a fever, loss of appetite, chills, for 24 hours. Sunday night had trouble breathing SOB. used humidifier. Chest felt tight. minor cough, symptoms similar to asthma.
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| 67 | 2021-03-08 | diarrhea, vomiting |
vomiting, diarrhea, chills Thursday 9:00 PM to Friday 9:00 AM rash over entire body, pins and needle...
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vomiting, diarrhea, chills Thursday 9:00 PM to Friday 9:00 AM rash over entire body, pins and needles effects Friday 8:00 PM to Saturday 10:00 rash continues but not as severe to currently Tuesday at noon Jaundice, elevated liver enzymes, and elevated billirubin started Saturday to currently Tuesday at noon
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| 67 | 2021-03-08 | nausea, decreased appetite |
Intense pain at injection site but no swelling or redness Intense body and joint pain and muscle cra...
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Intense pain at injection site but no swelling or redness Intense body and joint pain and muscle cramps. Difficulty walking. Fatigue. Chills and Fever 102.2 degrees. Brain fog and off-balance could not sleep but no headache. Nausea —no appetite. Nasal congestion and mild cough. Symptoms woke me at 2 am with chills. Took 500 mg acetominophin at 10 am. Forgot to take medication resulted in high heart rate and blood glucose. Symptoms started to decrease after 2 pm 2/28/21. Took 500 mg acetominophin around 3 pm. Fever 100. 5 on 3/1. Fever 100 on 3.2 Felt better but cancelled morning appointment on 3/3. Went for short walk outside on 3/5/21. Did not seek medical care. Still have muscle pain fatigue and brain fog.
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| 67 | 2021-03-08 | nausea |
No symptoms until 8:30 PM on fifth night after injection. Headache, unable to sleep fifth night aft...
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No symptoms until 8:30 PM on fifth night after injection. Headache, unable to sleep fifth night after injection. Dizziness beginning 9:00 AM and lasting all day sixth day after injection; Nausea and shortness of breath beginning 7:00 PM on sixth after injection; able to sleep sixth night after injection. Fatigue and shortness of breath beginning 8:00 AM and lasting all day seventh day after injection until 8:00 AM eight day after injection. Side effects were moderate, subsided on their own.
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| 67 | 2021-03-09 | decreased appetite, nausea |
bone ache; body shaking chills; no appetite; exhaustion; headache; occasional nausea; incapacitating...
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bone ache; body shaking chills; no appetite; exhaustion; headache; occasional nausea; incapacitating fever; This is a spontaneous report from a contactable consumer, the patient. This 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9265), dose 2 , single dose via an unspecified route of administration in the left arm on 02Feb2021 at 14:00 (at the age of 67 years-old) for COVID-19 vaccination. The patient was not pregnant. Medical history included primary immunodeficiency, diabetes, irritable bowel disease, gastroesophageal reflux disease (GERD), high cholesterol and allergy to cefazolin (ANCEF). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3248, dose 1 on 12Jan2021 at 2:15 PM in the left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included famotidine, lansoprazole, pioglitazone and rosuvastatin. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 03Feb2021 at 09:00 AM, the patient experienced bone ache, body shaking chills, no appetite, exhaustion, headache, occasional nausea and incapacitating fever. Treatment was not received for the events. The clinical outcome of bone ache, body shaking chills, no appetite, exhaustion, headache, occasional nausea and incapacitating fever was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 67 | 2021-03-09 | decreased appetite, nausea |
Violent entire body chills approximately 12 hrs after vaccine. Chills lasted an hour with 3 blanket...
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Violent entire body chills approximately 12 hrs after vaccine. Chills lasted an hour with 3 blankets and heating pad. Then switched to fever for next 8 hours. Fever recorded 102 the only time I checked. Nausea, body aches, plugged nose making it slightly difficult to breathe, headache, and exhaustion. Unable to sleep through the night due to fever, aches, and breathIng discomfort. Slept off and on all following day. Able to eat minimally at dinner next day. Strong taste of food, ie chicken soup seemed way strong. Third day tired but appetite slightly returning and other side effects seem subsided.
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| 67 | 2021-03-09 | decreased appetite |
4 hours after injection felt like I had Covid coming back on me. Felt sever headache, elevated tempe...
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4 hours after injection felt like I had Covid coming back on me. Felt sever headache, elevated temperature, chills flurry vision. Lack of appetite. Just general malaise?. Laid on couch after taking Tylenol Extra Strength 2 tablets and napped.
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| 67 | 2021-03-10 | nausea, diarrhea |
On Saturday-Sunday, March 6-7 I had diarrhea, nausea, chills and body aches. Beginning Wednesday, ...
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On Saturday-Sunday, March 6-7 I had diarrhea, nausea, chills and body aches. Beginning Wednesday, March 10 and continuing to the present, I have had an itchy rash over much of my body--arms, stomach, and back of legs.
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| 67 | 2021-03-10 | nausea | Headache, nausea, patch of hives on face. |
| 67 | 2021-03-12 | diarrhea |
Severe pain in left arm, unable to raise arm or lift anything. Sudden, profuse diarrhea unlike anyth...
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Severe pain in left arm, unable to raise arm or lift anything. Sudden, profuse diarrhea unlike anything I've ever experienced (about 6 hours after shot).
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| 67 | 2021-03-12 | nausea, vomiting, diarrhea |
Nausea, vomiting, diarrhea, dizziness, swelling, and soreness at the injection site, unable to raise...
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Nausea, vomiting, diarrhea, dizziness, swelling, and soreness at the injection site, unable to raise arm without pain
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| 67 | 2021-03-12 | nausea | Nausea after 6 hours. Temperature rise of 2 degrees at 12 hour mark that lasted for 36 hours. |
| 67 | 2021-03-13 | nausea, gastrointestinal pain |
ongoing symptoms of headache, muscle aches, fatigue, insomnia, elevated temperature( no fever above ...
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ongoing symptoms of headache, muscle aches, fatigue, insomnia, elevated temperature( no fever above 99 degrees) joint aches, swollen lymph nodes, sweats, scratchy throat, red irritated eyes, bowel cramps and nausea
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| 67 | 2021-03-13 | nausea | Extreme chills, nausea, about 2 hours |
| 67 | 2021-03-14 | abdominal pain |
Abdominal cramps/really bad cramps in my abdomen; a bit of a headache; This is a spontaneous report ...
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Abdominal cramps/really bad cramps in my abdomen; a bit of a headache; This is a spontaneous report from a consumer. A 67-years-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no:EN9581, expiration date:31May2021) as first dose, on left arm, via an unspecified route of administration on 28Jan2021 15:30 at single dose for covid-19 immunisation. Medical history included Kidney transplant recipient from 1995 and ongoing. There were no concomitant medications was not reported. This consumer reported that she was administered the first dose of Pfizer-BioNTech COVID-19 Vaccine 28Jan2021 about 15:30. On 28Jan2021 about 19:30 she had onset of abdominal cramps. Patient also reported that she received the Pfizer shot yesterday at around 3:30, then at around 7:30 she experienced really bad cramps in her abdomen, along with a bit of a headache. She asked if that is one of the side effects of the Pfizer-BioNTech COVID-19 Vaccine. She was a little concerned because she heard that if you had a reaction or side effects to the first dose of the Pfizer-BioNTech COVID-19 Vaccine that they would be worse with the second dose. She had abdominal cramps all night long off and on. She reported outcome as ongoing but a little bit better. She did better if she just stays still. When she gets up and starts doing things the abdominal cramps occur more. She described the abdominal cramps as being kind of like menstrual cramps, which she has not had in a long time, but they are low like that in the abdomen; not like stomach cramps that are up higher. Usually with something like this kind of abdominal cramps she would have diarrhea but she was not having any diarrhea. The abdominal cramps are weird feeling. Outcome of the event abdominal cramps/really bad cramps in my abdomen was recovering and outcome of other event was unknown.
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| 67 | 2021-03-14 | nausea, decreased appetite |
Approximately 24 hours after vaccine, had symptoms very similar to when I had Covid in January - tir...
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Approximately 24 hours after vaccine, had symptoms very similar to when I had Covid in January - tired, queasy stomach, headache, no appetite. Thought I was doing better after 48 hours but had a relapse last night with fever and chest pains. When I take a deep breath, feel pain in my chest.
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| 67 | 2021-03-14 | nausea |
nausea; dizzy; chills; body aches; headache; trouble concentrating; very sore arm; This is a spontan...
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nausea; dizzy; chills; body aches; headache; trouble concentrating; very sore arm; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 67-year-old non-pregnant female patient (Patient was not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: E1823886, Expiry date: unknown), via an unspecified route of administration on 09Feb2021 at 10:00 (age at the time of vaccination was 67-year-old) on right arm at single dose for covid-19 immunisation. Medical history included allergy to Sulfa. Concomitant medication patient received within 2 weeks of vaccination included Hydrochloride, potassium chloride (K-DUR), vitamin d3, irbesartin. The patient experienced nausea, dizzy, chills, body aches, headache, trouble concentrating and very sore arm on 09Feb2021. The events were considered as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The patient was recovering from the events.
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| 67 | 2021-03-14 | nausea | Nausea muscle aches chills very painful left arm |
| 67 | 2021-03-14 | nausea |
My arm did get sore and it had stayed sore; I am also experiencing nausea; headache; not feeling wel...
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My arm did get sore and it had stayed sore; I am also experiencing nausea; headache; not feeling well; felt feverish; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL8982), via an unspecified route of administration on her arm on 25Jan2021 10:00 at single dose for covid-19 immunisation. Medical history included raynaud's phenomenon. She was told that she could not donate plasma because of it but she have raynauds, she stated she is not taking medications or anything for it, it's just she get chills in her hands and feet from anything if she drink anything cold or get chilled or whatever, white they turn white. It was reported that patient had Covid 19 and was tested positive for antibodies back in June. The patient's concomitant medications included estradiol (Cream, its a hormone cream), vaginally at 13 micro grams, twice a week for unknown indication and acyclovir for unknown indication. In Jan2021, patient reported that her arm did get sore and it had stayed sore and she is also experiencing nausea, she had experienced nausea that night, a headache, not feeling well and felt feverish didn't recorded fever but her concern is that it's not going away. The patient received treatment just advil (as reported). The events were considered as non-serious. The outcome of the event felt feverish was not recovered and outcome of other events unknown.
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| 67 | 2021-03-14 | nausea | Fever, chills, nausea, body aches. |
| 67 | 2021-03-14 | vomiting, diarrhea |
Vomiting; Diarrhea; Sweating and shivering all night; Sweating and shivering all night; This is a sp...
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Vomiting; Diarrhea; Sweating and shivering all night; Sweating and shivering all night; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the second dose of received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL1283) in the left arm, at single dose, on 03Feb2021 at 07:15, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included hypertension. No known allergies were reported. The patient had not experienced Covid-19 prior vaccination. The patient previously, on 12Jan2021, at 07:00 AM, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EK9231) in the left arm, for COVID-19 immunisation. Concomitant medications included metoprolol, simvastatin, telmisartan and buspirone hydrochloride (BUSPAR). On 05Feb2021, at 10:00 PM, the patient experienced vomiting and diarrhea, sweating and shivering all night. Post the vaccination, the patient has not been tested for COVID-19. No treatment was received. The patient recovered from the events on an unspecified date.
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| 67 | 2021-03-15 | diarrhea, nausea |
Nausea; Diarrhea; Fever; This is a spontaneous report from a contactable consumer (patient). A 67-ye...
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Nausea; Diarrhea; Fever; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EM9810), via an unspecified route of administration on 05Feb2021 at a single dose on left arm for COVID-19 immunisation. Medical history was not reported. There were no concomitant medications. The patient was asking if Pfizer had people, about 3 or 4 days later, get nausea and diarrhea after getting the COVID shot. She had a real bad fever 3 hours after the shot but felt fine the next day. But now she has nausea and diarrhea that started yesterday (08Feb2021). She normally does not that have that. Her nausea has improved because she took a nausea pill, ondansetron (ZOFRAN) 2 mg. Therapeutic measures were taken as a result of nausea. The outcome of the event fever was recovered on 06Feb2021, nausea was recovering, and diarrhea was recovered on 09Feb2021.
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| 67 | 2021-03-15 | nausea |
nausea, dizziness and chest compression with in 15 minutes of shot. oxygen and laid supine flat. I...
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nausea, dizziness and chest compression with in 15 minutes of shot. oxygen and laid supine flat. Itchiness within 60 minutes. Benadryl 25 mg. Resolution post shot 3 hours, released home. At 3 PM I experienced chest compression again and used my rescue inhaler with resolution of sx, also took another benadryl Note: I was premedicated with zyrtec and 50 mg of diphenhydramine at the time of the second shot
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| 67 | 2021-03-15 | nausea |
Arm has been burning for 2 2/2 weeks. The injection was given up high. Also woke up with nausea whi...
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Arm has been burning for 2 2/2 weeks. The injection was given up high. Also woke up with nausea which has lasted over a week. Spent first day after injection in bed. Felt feverish and had absolutely no energy. Felt that way for about two or three days. For about a week had very little energy. My arm through the shoulder blade and in the back still has a burning sensation.
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| 67 | 2021-03-15 | nausea |
pinching all over body; mildly nauseated; Plantar fasciitis; The pain in my foot became excruciating...
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pinching all over body; mildly nauseated; Plantar fasciitis; The pain in my foot became excruciating; could barely walk; The pain in my foot became excruciating; could barely walk; This is a spontaneous report from a contactable Consumer (patient). A 67-year-old female patient received second dose bnt162b2 (PFIZER COVID 19 VACCINE, lot number= EL9263), via an unspecified route of administration in right arm on 19Feb2021 09:30 AM at single dose for COVID-19 immunization. Medical history included known allergies to Sulfites, Iodine as contrast, Dairy, Gluten. Concomitant medication included levothyroxine, liothyronine (NP THYROID), latanoprost (LATANOPROST) and Supplements (Other medications in two weeks). The patient was not pregnant. The patient did not have COVID prior vaccination. The patient did not have COVID tested post vaccination. The patient received first dose bnt162b2 (PFIZER COVID 19 VACCINE, lot number= COVID-19 immunization), via an unspecified route of administration in right arm on 29Jan2021 11:30 AM at single dose for COVID-19 immunization. The patient did not have other vaccine in four weeks. 19Feb2021 after 2nd shot: pinching all over body and mildly nauseated. Plantar fasciitis left foot had no pain for 24 hours. 24 hours later: no nausea. The pain in the foot became excruciating; could barely walk. Lasted 2 days. Milder now. Adverse event start date was 19Feb2021 10:30 AM. The outcome of the events was recovering.
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| 67 | 2021-03-16 | abdominal discomfort, diarrhea |
Day 2 diarrhea, fever and upset stomach Day 2 broke out all over my chest and stomach and just don't...
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Day 2 diarrhea, fever and upset stomach Day 2 broke out all over my chest and stomach and just don't feel good
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| 67 | 2021-03-16 | abdominal pain |
pt developed bad case of shingles on Left abdomen to left side of back. Went to Urgent care 3/12 an...
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pt developed bad case of shingles on Left abdomen to left side of back. Went to Urgent care 3/12 and was given acyclovir and cephalexin. pt is having stabbing pain on abdomen and back
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| 67 | 2021-03-16 | burping | Left chest pressure and belching episodes. |
| 67 | 2021-03-17 | nausea, vomiting |
3/14/21: 10:00 pm violent hand tremors - 3 hours 3/14/21: 10:30 pm nausea 3/14/21: 11:00 pm vomiti...
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3/14/21: 10:00 pm violent hand tremors - 3 hours 3/14/21: 10:30 pm nausea 3/14/21: 11:00 pm vomiting every hour - 7 hours and off and on the next 48 hours 3/15/21: 10:00 am extreme joint pain 48 hours 3/15/21: 10:00 am headache off and on 72 hours 3/16/21: 3:00 am 102.4 temperature (couple of hours?)16 3/16/21: 12:00 pm sore throat 24 hours 3/16/21: Fatigue Continues 3/16/21: Very dizzy 3/17/21: 3:00 pm injection side tenderness and slight swelling 48 hours 3/18/21: 3:00 pm first time able to get out of bead and shower - slight light headedness
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| 67 | 2021-03-17 | nausea | Migraine, chills, nausea, dizziness, fever |
| 67 | 2021-03-17 | nausea |
Sore arm at injection site, bad headache, chills, fever, aches in joints, back pain, nausea, tiredne...
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Sore arm at injection site, bad headache, chills, fever, aches in joints, back pain, nausea, tiredness Treatment, sumatriptan for headaches, Advil for aches , pain and fever. I was in bed for 2 1/2 days because I felt so sick and was very tired Most of my symptoms were better after 3 days but the headaches and tiredness are still bothering me today 3/18/21.
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| 67 | 2021-03-17 | stomatitis, nausea, decreased appetite, abdominal distension |
Severe rash covering entire lower back, severe sore throat and mouth with sores, cough, some shortne...
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Severe rash covering entire lower back, severe sore throat and mouth with sores, cough, some shortness of breath, low grade temp., extreme lethargy, nausea, bloating, peeling of the tips of my fingers on the palm side, loss of appetite.
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| 67 | 2021-03-17 | vomiting | Fever and chills lasting 8 hours Vomiting |
| 67 | 2021-03-18 | abdominal pain upper, decreased appetite |
Losing her mind/ mental fog; No appetite and went 32 hours without eating/He stated she's lost her a...
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Losing her mind/ mental fog; No appetite and went 32 hours without eating/He stated she's lost her appetite; heard in the background stating the COVID-19 Vaccine screwed up her mind; Headache; Eyes hurt/Her eyes felt like they were going to pop out; Feels tired and weak; Feels tired and weak; can't think straight; pain in head and stomach; change of mood; altered mental status and nightmares; altered mental status and nightmares; she is so mean to everybody / not acting normal; her eyes felt like they were going to pop out; Suicidal thoughts/thinking of committing suicide; This is a spontaneous report from a contactable consumer from a Pfizer sponsored program. A 67-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EL267, expiry date 31May2021) via an unspecified route of administration, at the age of 67-year-old, on 24Feb2021, as SINGLE DOSE (0.3mi as reported) for COVID-19 immunisation. Medical history included type 2 diabetes mellitus and ongoing allergy to penicillin. There were no concomitant medications. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL9265, expiry date 31May2021) via an unspecified route of administration, on 03Feb2021, single dose for covid-19 immunisation wherein the patient had to got to Emergency room and it was found that her magnesium and potassium were low. The patient had a super bad reaction to the Pfizer vaccine. Patient's mind has not been normal ever since and she is so mean to everybody. The patient was fine until she got the vaccine. The reporter has had the ambulance and police up there to try and help but the caller wouldn't go out to the hospital. The patient had a normal mind before she got the shot. The patient has a bad headache that will not go away (8 days) and her eyes are hurting really bad/eye pain/ eyes hurt. She feels so tired and weak. The second COVID-19 Vaccine messed the patient up. She had the same symptoms for both first and second dose (unspecified symptoms), but the second dose has really messed up her mind. Patient probably won't have a mind. It was reported that the patient's mind was alright, but the second COVID-19 Vaccine did her in. Now patient is saying she won't get her mind back. It has messed up her mind. Clarified when caller states it messed up her mind, he is referring to the patient being mean. Stated patient did have a headache, but wasn't hateful. Stated patient's mind is so bad, she is just mean. If patient doesn't get help soon she is going to tell herself good night. Patient stated in background "If I don't get my mind back I'm going to end up killing myself because he made me." At 11PM last Wednesday (24Feb2021), patient starting losing her mind. Confirmed with caller that patient is currently having suicidal thoughts. Patient used to be a real nice lady and blames this on the COVID-19 Vaccine. Patient is afraid she is not going to get her mind back. Advised caller to seek emergent medical attention for the patient. Patient is against everybody now because of the crazy COVID-19 Vaccine. Patient heard in the background stating the COVID-19 Vaccine screwed up her mind. Caller stated patient is quite upset with everybody. Patient is not acting normal. Patient doesn't think her mind will ever get straightened. The medicine was too much for her body. After getting the second dose, the patient lost her mind, she's lost her appetite/ No appetite and went 32 hours without eating, can't think straight, altered state of mental, mental fog, pain in head and stomach, change of mood, nightmares, her eyes felt like they were going to pop out. Her doctor said it was probably an overdose. The patient was not like this prior to second dose. Outcome of the event was unknown. The reporter believes her mental fog is due to second dose of vaccine.
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| 67 | 2021-03-18 | nausea, vomiting, diarrhea |
1AM Sat. March 6: Woke up shivering, lasted on and off throughout the day) Also had a Severe migra...
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1AM Sat. March 6: Woke up shivering, lasted on and off throughout the day) Also had a Severe migraine, severe nausea, lower leg cramps, and vomited 5 times until nearly 5PM ( last 3 times was water that was sipped but "heaved") mild diarrhea. Family offered to take me to hospital at since I had trouble "holding down" sips of water. Dozed off about 11PM and woke up at 1AM feeling better. Nausea and headache had subsided greatly, Congestion lasted until Sat. Took a 24 hour non drowsy Sudafed on Thursday and Friday. Rested Sunday and ate very light (toast; applesauce).
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| 67 | 2021-03-18 | nausea, vomiting |
Patient is being hospitalized for COVID-19 pneumonia. The patient has had a pulse ox reading in the ...
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Patient is being hospitalized for COVID-19 pneumonia. The patient has had a pulse ox reading in the low 90s and feels short of breath. She had a positive COVID-19 test collected on 3/16/21. She has fatigue and nausea/vomiting. The patient received Regeneron antibody infusion and dexamethasone. In ED, patient is requiring 2 L of O2 to maintain O2 saturation of 96%. Patient is being admitted.
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| 67 | 2021-03-18 | nausea |
feeling light headed; mild headache; fatigue; erratic bp/ spike in her blood pressure; feeling nause...
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feeling light headed; mild headache; fatigue; erratic bp/ spike in her blood pressure; feeling nauseous; accelerated HR; she had body shakes/body was trembling; to the point she thought she was going to pass out; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: EL1284) at vaccination age of 67-year-old via an unspecified route of administration on 28Jan2021 at a single dose to prevent COVID19 (covid-19 immunisation). Medical history included interstitial lung disease and overactive thyroid (She was treated for overactive thyroid, but it has been stable for five years). Concomitant medication included nitrofurantoin for interstitial lung disease and fluticasone. The patient previously took prednisone [prednisone acetate] (She did ten weeks of Prednisone and has been off Prednisone since the middle of Nov2020. She started at 30mg and tapered down to 20mg then to 10mg and then to 5mg until she was done). The patient experienced feeling lightheaded, mild headache, fatigue, erratic bp 01Feb2021 11:30, feeling nauseous on an unspecified date in 2021. Took Pfizer Covid 19 vaccine last week. Began feeling lightheaded, mild headache, fatigue, erratic BP on Monday, 4 days after receiving the vaccine. Went to Emergency department on Monday evening. Has been continuing off and on since Monday. Can these symptoms occur after 4 days patient questioned. Has already reported to DSU. She got Pfizer's COVID19 Vaccine a week ago today. She was doing fine and then Monday she started with mild headache, erratic blood pressure readings. She ended up in the ER because it was so high. It stabled out and she went home. She was feeling ok on Tuesday, but not quite normal. She was fine yesterday until last night then it started again with erratic blood pressure, fatigue, mild headache and lightheadedness. The headache is never pounding. The lightheadedness won't go away. Is that normal to have that many days after receiving the vaccine? It was four days before she started experiencing it. Now she feels kind of normal as long as she is laying down except for headache. As of 15Feb2021, the patient reported that she called a couple weeks ago and reported adverse side effects and she needed a couple questions answered. She mentioned that she was due to have the second vaccine this weeks (18Feb2021). She was extremely worried about doing it because even some of the effects she had after 4 days in the first vaccination have not subsided. She added that it landed her in emergency room a couple of times (also reported as ended up in the ER twice). She inquired if should she take the second one at this point or can she wait and if she can wait for how long. She mentioned that she had a spike in her blood pressure (BP), she had accelerated HR on an unspecified date in 2021, she was very lightheaded to the point she thought she was going to pass out on an unspecified date in 2021. The second time around, her body was trembling on an unspecified date in 2021, she had body shakes. It was not fun. All of these effects have returned to somewhat normalcy, but she is still experiencing lightheadedness. She has seen her own physicians, but she is not sure if she should proceed with the second vaccine. The outcome of the event lightheadedness was not recovered while the outcome of the other events was recovering. Follow up (15Feb2021): New information received from a contactable consumer (patient) included: lab data, new event (accelerated HR, to the point she thought she was going to pass out, body shakes/trembling) and clinical course of the events.
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| 67 | 2021-03-18 | vomiting, nausea | Nausea, emesis, chills, and fatigue. |
| 67 | 2021-03-18 | vomiting |
Rash; Joints and fingers swelling/hands were swollen; Joints and fingers swelling; wrist was sore; F...
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Rash; Joints and fingers swelling/hands were swollen; Joints and fingers swelling; wrist was sore; Freezing and chills; Felt like would pass out/felt so faint; Ate dinner but food came back up; Shortness of breath; Cheeks flushed; Achy; felt draggy/feeling tired; This is a spontaneous report from a contactable. A 67-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCIN) lot number: GL9266, via an unspecified route of administration, administered in left arm on 21Feb2021 as single dose for COVID-19 immunisation. Medical history included rheumatic fever (occurred age 7), vulvovaginal dryness and sore joints. The patient was negative on Covid test on an unspecified date. Historical vaccine included BNT162B2 on 28Jan2021 for COVID-19 immunisation and flu shot. Concomitant medications included estradiol (IMVEXXY) taken for vulvovaginal dryness; vitamin C [ascorbic acid] (VITAMIN C); colecalciferol (VITAMIN D); calcium. On Monday, 22Feb2021, the patient felt draggy, but did not think it was a big deal. She just thought it was from the shot and was feeling tired. The draggy feeling lasted a few days, but she was unable to clarify outcome further. On Tuesday, she started to feel achy and felt like that too was to be expected. The achiness went away on 25Feb2021. On Wednesday, 24Feb2021, she was really busy. She was still achy but was busy. She also did not drink much water for several hours. It dawned on her later when she was not feeling good. Late Wednesday afternoon it was like everything cratered and she felt horrible. She was feeling bad. She was freezing and had chills. It was a horrible feeling. She helps with her grandkids since she is retired. They were home from school and had to sit on the couch. She felt cold, yucky, and achy. It was a yucky feeling. She went home a couple of hours later. She told her husband she had to lie down on the couch because she felt horrible. She could not further describe horrible feeling. Her daughter had called her as well and was unable to describe how she felt to her daughter. She could only say she felt so sick but could not explain further. She felt awful and could not put her finger on it. She was laying down and when she got up, she felt like she would pass out. At that time, she had not eaten dinner yet. She ate dinner, took one bite and the food came back up. For a few moments she felt so faint, she felt shortness of breath, but it was only for a few seconds. After that, her and her and her husband took a drive to go to hospital. However, by the time she got to hospital she was feeling better. She was also talking to a friend at that time who said all of this was probably form the shot as well. Since she was feeling better decided not to go into the hospital and went back home. At the time she was thinking this was all from the shot and no big deal. On Wednesday night, things got crazy and worse. That evening Wednesday she was getting ready for bed and noticed her cheeks were flushed. On Thursday she got up and noticed rash. She was covered all over her body. It did not itchy really, but it was a rash. Not a bumpy rash, it reminds her of Roseola. Her joints and fingers were starting to swell. Her hands were swollen. It started with her knuckles, it went to her fingers, up to her hands, wrist. Her wrist was sore. Her joint swelling was worse. On Friday, she tried to see her doctor, but could not be seen by the doctor. However, she got in with the PA. When she saw the doctor, it could be seen her hands were swollen. However, the main reason she went to the doctor was due to the rash. However, her joints were sore and swollen. Treatment for rash included Hydroxyzine, for joints and fingers swollen/ wrist was soreincluded prednisone 10mg one tablet every day for five days. The patient recovered from the event felt like would pass out/felt so faint and shortness of breath on 24Feb2021. The outcome of the events joints and fingers swelling/hands were swollen, wrist was sore and cheeks flushed was not recovered.
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| 67 | 2021-03-19 | abdominal pain upper |
I had somewhat similar results the 1st does. Same symptoms w/o fever 1st does. Chills, headache mu...
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I had somewhat similar results the 1st does. Same symptoms w/o fever 1st does. Chills, headache muscle aches joint pain fatigued. 2nd does, all the symptoms listed. I took tums and Advil which helped. This time had fever which lasted 24hrs. Stomach pains the time along with the other symptoms. Not unlike the actual virus I had!
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| 67 | 2021-03-19 | nausea, diarrhea |
Pulsatile Tinnitus in left ear started 5 days after 2nd dose administered and is ongoing. Other eff...
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Pulsatile Tinnitus in left ear started 5 days after 2nd dose administered and is ongoing. Other effects post 2nd dose had resolved before tinnitus began. Other effects experienced were headache, nausea, itching at injection site, diarrhea, fatigue
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| 67 | 2021-03-19 | nausea | Nausea headache sore arm |
| 67 | 2021-03-19 | nausea |
I got a headache at the base of my skull (very unusual for me and it lasted for 36 hours) within an ...
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I got a headache at the base of my skull (very unusual for me and it lasted for 36 hours) within an hour of the shot and became quite fatigued a couple hours later. Approximately 8 hours after injection I began having severe chills with teeth chattering and muscle cramps and aches. which lasted for three exhausting hours. Then suddenly I had a fever of 101 degrees and body aches and nausea with extreme fatigue until 4:00 PM the next day. The fatigue and brain fog continued until 48 hours or so after the shot. My arm did not hurt at all by the way. Nurse had me pull my arm down in an exaggerated way as she gave me the shot and it seems to have helped.
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| 67 | 2021-03-20 | difficulty swallowing |
Bad taste in mouth followed by increasing chest pain. B/p 200/100 (nl low) increase chest pain gradu...
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Bad taste in mouth followed by increasing chest pain. B/p 200/100 (nl low) increase chest pain gradually better over 45?. Tried to leave didn?t get out of bldg, collapsed in chair bad chest pain felt really bad. Ambulance called, gradually progresses to weak r side hi b/p slurred stammering speech inability to swallow tongue thrusting to Uc health ct w contrast ok. Gradually improved discharged at 1700. Saw doctor following Monday. Cardiac work up scheduled 4/5/21 She does not want 2nd vaccine until cleared by cardiologist. I have had bouts of chest pain. Hospital tadmitted me as Jane doe. Severe fatigue sleeping 12-14 h/ d for 5-6 d no fever flu sx. Low energy. Hospital never took he from me once better discharged as migraine but I don?t have migraines
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| 67 | 2021-03-20 | flatulence, abdominal pain |
-About 20-25 minutes after received vaccine, had already left the facility felt a surge tightness wr...
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-About 20-25 minutes after received vaccine, had already left the facility felt a surge tightness wrap around my diaphragm up to my collar bone, as if my breath was being taken away. I yelped out but the three people in the car with me did not here me. I remained calm took a deep breath- feeling went away. - Had vaccine on Saturday. Woke up in the night on Sunday night, feeling like my tongue was swelling and my throat was closing up. I took 1/2 Benadryl and used Albuterol enhaler. Temp was 99.8 (my average at home is 96.5)Fell back asleep. Woke up the next day and was fine. - other symptoms were tiredness, headaches, achy joints, which went away fairly as quickly. -since the vaccine I have had a bad outbreak of do
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| 67 | 2021-03-21 | diarrhea |
Arm sore when I got home that evening. Up at 4:00 with chills and fever which last 4 days. Diarrhea...
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Arm sore when I got home that evening. Up at 4:00 with chills and fever which last 4 days. Diarrhea stated at 6:00 am the day after my second shot and lasted 10 days.
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| 67 | 2021-03-21 | nausea, diarrhea |
2nd shot caused dizziness, loss of balance, nauseous, unable to eat, diahera, headache. Going on sin...
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2nd shot caused dizziness, loss of balance, nauseous, unable to eat, diahera, headache. Going on since evening of day of injection.
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| 67 | 2021-03-21 | vomiting | vomiting, dizziness, headache, |
| 67 | 2021-03-22 | nausea | Fever of 101.7 with severe body aches, headache, chills, nausea |
| 67 | 2021-03-22 | nausea |
Fever, chills, severe nonstop headache, including my entire face, nausea, complete body ache, fatigu...
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Fever, chills, severe nonstop headache, including my entire face, nausea, complete body ache, fatigue, weakness, sudden sweating and severe nausea, extreme weakness disableing my ability to walk upright to even get to the bathroom. This lasted 3 days 03/16/2021 through 03/18/2021. Sever symptoms decreased to managable levels by 03/19/2021, except for off and on nausea. Fatigue, lack of energy and weakness still remain as of the report 03/23/2021
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| 67 | 2021-03-23 | nausea | Bad headache Fever Fatigue Nausea Rash |
| 67 | 2021-03-23 | nausea | chills, fever of 101.6 with Tylenol on board, headache, chest tightness, nausea, malaise |
| 67 | 2021-03-23 | retching |
1/11 vaccination 1/15 COVID - 1/18 I had a scheduled colonoscopy at 10AM. Close to 11AM, started IV ...
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1/11 vaccination 1/15 COVID - 1/18 I had a scheduled colonoscopy at 10AM. Close to 11AM, started IV sedation, put me on my side. I remember gagging and then i woke up. My chest was burning and they were talking to them, OZ mask because SPO2 had dropped to 48. They needed to monitor me longer, took to recovery, and put on bronchodilator (?) thru the O2 mask. They started and IV antibiotic for 90 minutes. SPO2 went back to 98. I went home, felt weak. The Dr said to take it easy next couple of days. Work stated to only come back when feeling normal. My husband tested for COVID 20th. 1/26 I tested COVID +. I felt like it would be negative due to having both vaccines but it wasn't.
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| 67 | 2021-03-24 | abdominal discomfort, diarrhea |
Minimal reaction the first 2 days after receiving the shot. on the 3rd day I became fatigued but not...
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Minimal reaction the first 2 days after receiving the shot. on the 3rd day I became fatigued but noticed some lower abdominal discomfort. 4th day had loose stools and noticed some burning when urinating.. Late in the day had a splitting headache, i never get headaches, took Tylenol and felt better. At 2 am that night woke up with teeth chattering and limbs shaking. Urinated and noticed a pink tinge. My husband took me to the ER ( He had had a similar reaction to his first Pfizer shot) Found to have a fever, increased heart rate and a raging bladder infection (significant amount of blood in urine). Treated with Keflex via IV . Went home with a presciption for Keflex They are running a culture. I HAD COVID IN NOVEMBER AS DID MY HUSBAND IT APPEARS THAT MAYBE ONE DOSE WOULD HAVE BEEN SUFFICIENT FOR US. I HOPE THIS WILL BE EVALUATED AND THE PUBLIC INFORMED OF BEST PRACTICE
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| 67 | 2021-03-24 | diarrhea, abdominal discomfort |
Approximately 10pm I started getting diarrhea. I had 5 bouts of it during the first night. I took pe...
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Approximately 10pm I started getting diarrhea. I had 5 bouts of it during the first night. I took pepto bismal and it stopped for one day , which was the 21st. On the 22 I woke up with more diarrhea and took Imodium. It stopped the rest of the day until evening when my stomach started to feel like Ibwss going to get nauseated. I took an Imodium. 23 I felt a little nauseous and took pepto bismal. 24 and 25th I feel fine but I still have soft stools and some water excrement. A little ache in left arm for a little bit of time today.)
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| 67 | 2021-03-24 | diarrhea, vomiting |
Started with loss of taste on Tuesday p.m.. Just after 4am, I awoke my husband because I was about t...
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Started with loss of taste on Tuesday p.m.. Just after 4am, I awoke my husband because I was about to vomit. From there I was going in and out of consciousness. My husband took my temp and it was just over 104 degrees. He wanted to call an ambulance to take me to the ER, but I refused not realizing how bad off I was. This went on for about 4 hours. My husband applied ice cold wash cloths to my forehead and back of my neck for hours. He finally was able to bring my temp down some. I used the cold cloths for just over two days. I was so fatigued I was unable to walk without help. Had a bad headache too. My husband gave me Tylenol off and on for days. My fever finally broke on the 5th day. I am still left with bad fatigue and some headache. Have also had diarrhea. My husband kept fluids in me which also included Ensure. I had terrible fever blisters on my lower lip and the inside of my mouth was sore. I am due to have my 2nd shot in about a week, but because I still have some lingering symptoms, was advised to not have 2nd shot.
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| 67 | 2021-03-24 | diarrhea, vomiting |
Evening of vaccine and most of following night, I had severe diarrhea, continuing into next day. The...
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Evening of vaccine and most of following night, I had severe diarrhea, continuing into next day. The day after that, I could not hold food down and still can?t.
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| 67 | 2021-03-24 | diarrhea |
No symptoms first dose 2nd dose: 18 hours- headache 24 hours-joints ache, sore arm 52 hours- diarrh...
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No symptoms first dose 2nd dose: 18 hours- headache 24 hours-joints ache, sore arm 52 hours- diarrhea, sore arm 74 hours- diarrhea
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| 67 | 2021-03-24 | difficulty swallowing |
Couldn?t swallow good, itchy ears and throat, blood pressure 170/87 , elevated heart rate, numb lips...
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Couldn?t swallow good, itchy ears and throat, blood pressure 170/87 , elevated heart rate, numb lips, bad headache. I received a shot of benedryl and steroids.
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| 67 | 2021-03-24 | nausea, decreased appetite |
Severe chills, migraine, some nausea, zero appetite, body muscle pain and joint ache, soreness at va...
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Severe chills, migraine, some nausea, zero appetite, body muscle pain and joint ache, soreness at vax site and extreme tiredness. Symptom onset was 12 hours after the shot.
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| 67 | 2021-03-24 | nausea |
Severe nausea, temperature 102, aches, chills, severe headache, light sensitivity On 03/19/2021, con...
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Severe nausea, temperature 102, aches, chills, severe headache, light sensitivity On 03/19/2021, consulted with Dr and given Rx for Ondansetran, 8mg Symptoms receed over the next few hours
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| 67 | 2021-03-24 | nausea | Chills, headache, temperature 101, nausea, |
| 67 | 2021-03-25 | diarrhea |
A few hours after the shot, I experienced a mild bout of diarrhea. Then began to run a fever. The...
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A few hours after the shot, I experienced a mild bout of diarrhea. Then began to run a fever. The injection site and right arm became extremely heavy and painful. Overnight, I experienced fever, extreme muscle cramping and a burning sensation in all of my joints. Took a Tylenol at midnight which helped. Fever remained at 99.8 which is high for me. This lasted for the next 24 hours. Today, Friday the 26th, I am finally feeling better and fever is gone.
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| 67 | 2021-03-25 | difficulty swallowing |
After I left the center as I was driving home I couldn't swallow. I took a sip of water and started ...
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After I left the center as I was driving home I couldn't swallow. I took a sip of water and started to choke. I pulled in to the parking lot if the fire dept to see if it went away. I waited for about 5 more minutes and then I could swallow again.
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| 67 | 2021-03-25 | nausea, decreased appetite |
Couldn't get warm- very cold, her skin was very cold; Nausea; Pretty severe headache; Generalized ac...
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Couldn't get warm- very cold, her skin was very cold; Nausea; Pretty severe headache; Generalized aching; Fibromyalgia flare up; No energy been very tired; No energy been very tired; Felt like she was going to faint; Dizziness; Vision blurred; Loss of appetite; Flu-like symptoms; Hands feel warm to touch, but she still feels cold; She cannot sit or stand without discomfort in her spine; She cannot sit or stand without discomfort in her spine; Sick; Her bones and muscles hurt; Her bones and muscles hurt; Wheezing; This is a spontaneous report from a contactable Other HCP, the patient. A 67-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE,Lot Number: EM9809; Expiration Date: 30Jun2021), intramuscularly, on 01Mar2021 at 13:45 (at the age of 67 years old) as a single dose in the left deltoid for COVID-19 immunization. Medical history included having become disabled in 2009, arrhythmia from 2014 and ongoing which was diagnosed after she took a Hep C treatment (Sovaldi, Ribavirin, Olysio). She had to take these medications for five months, where most people have to take it for three, ongoing allergic asthma - allergic to "everything." She has had this her whole life, diagnosed when she was 5. Started treatment with steroids at 16 , Hepatitis C from 1996 to 2014 diagnosed 4 years after blood transfusions Could have already gotten it as a nurse, was much more resistant than the average person 5 weeks to go negative, ongoing hepatic failure from 2013- she went into liver failure from Hep C. An event occurred- exposure of a deadly toxin that came from China, ongoing fibromyalgia from 1992 -Immediately after blood transfusions when her son was born- Gave her the correct blood but her body reacted. Flu shot in Early Oct2020 Fibromyalgia flare up, 4 times the dose (as reported)- Onset Age 66, Seizure disorder which was diagnosed in 2016 after disseminated shingles; after 2.5 months started having black outs where she did things and said things no memory of, the only way she knew it happened is if there were consequences. Doesn't know if she still has those, but she is getting an MRI and EEG. She lost vision in her right eye 2 years ago due to retina surgery macular pucker. She thinks her liver was stealing Vitamin A from her eye. Medical history also includes she ran over herself with her car, blood pressure abnormal, hepatic encephalopathy, autoimmune thyroiditis, and anxiety all from unknown dates and unknown if ongoing. The patient has had cataracts since an unknown date prior to the vaccination. The patient was diagnosed with "Rocky Mountain" in 2009. She also mentioned that when she got the vaccine she did not tell them that she was on steroids and an antibiotic. She commented that she was not in good shape when she took the vaccine to begin with. She is immunosuppressed and thinks that she should not have received the vaccination. But she also stated that she took the vaccine because she is a severe asthmatic and does not have a strong immune system so if she got COVID, she would die. Concomitant medication included benazepril (BENAZEPRIL) for blood pressure abnormal from an unspecified start date and ongoing; amlodipine (AMLODIPINE) for arrhythmia from 2014 and ongoing; rifaximin (XIFAXAN) for hepatic encephalopathy from 2014 and ongoing; lactulose (LACTULOSE)for hepatic failure, ammonia abnormal from 2014 and ongoing; levothyroxine sodium (SYNTHROID) for autoimmune thyroiditis from 1984 and ongoing; omeprazole (PRILOSEC [OMEPRAZOLE]) for reflux gastritis, chronic gastritis from an unspecified start date and ongoing; alprazolam (XANAX) for anxiety, post-traumatic stress disorder from 2009 and ongoing; albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) for asthma from an unspecified start date and ongoing; ranitidine (RANITIDINE) for an unspecified indication, start and stop date were not reported.The patient previously took flu vaccine vii, olysio for hepatitis c and experienced histamine level increased, lyrica and experienced weight increased. Ten minutes after the vaccine was administered the patient experienced generalized aching on 01Mar2021 at 13:55 with outcome of not recovered. After twenty minutes she developed a pretty severe headache on 01Mar2021 14:05 with outcome of recovering. After 30 minutes she stared to feel nausea on 01Mar2021 at 14:15 with outcome of recovered. She stated that when she stood up to leave felt like started to feel dizzy on 01Mar2021 with outcome of unknown, and felt like she was going to faint on 01Mar2021 with outcome of unknown, her vision blurred on 01Mar2021 with outcome of not recovered and she had trouble getting into the elevator. She also experienced a loss of appetite on 01Mar2021 with outcome of recovering. The patient continued to describe her experiences noting that "things changed daily" and mentioning that she experienced fibromyalgia flare up on 01Mar2021 with outcome of not recovered, no energy been very tired on 01Mar2021 with outcome of not recovered , no energy been very tired on 01Mar2021 with outcome of not recovered , couldn't get warm- very cold, her skin was very cold on 02Mar2021 01:30 with outcome of not recovered, flu-like symptoms on 01Mar2021 with outcome of recovering, hands feel warm to touch, but she still feels cold on 01Mar2021 with outcome of unknown, she cannot sit or stand without discomfort in her spine on 01Mar2021 with outcome of unknown, she cannot sit or stand without discomfort in her spine on 01Mar2021 with outcome of unknown, sick in Mar2021 with outcome of unknown, her bones hurt in Mar2021 with outcome of unknown, her muscles hurt in Mar2021 with outcome of unknown, wheezing on an unspecified date in Mar2021 with outcome of unknown. Lab tests and procedures included cardiac output: over 50 percent, echocardiogram: her heart was good and clear, electroencephalogram with unknown results, magnetic resonance imaging with unknown results, all on unknown dates. Therapeutic measures were taken as a result of pretty severe headache; Sender's Comments: Based on the available information, the company considers that a causal relationship between generalized aching, severe headache, feel dizzy, going to faint, vision blurred, no energy been very tired, very cold, her skin was very cold, wheezing and bnt162b2 vaccine cannot be excluded due to plausible temporal association. The Company considers the reported event fibromyalgia flare up is unrelated to bnt162b2 vaccine but more likely due to underlying medical history of ongoing fibromyalgia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 67 | 2021-03-25 | nausea, diarrhea, vomiting |
Day of Vaccine, typical sore arm. Day2 sore arm & feeling out of sorts. Day3 started in the early am...
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Day of Vaccine, typical sore arm. Day2 sore arm & feeling out of sorts. Day3 started in the early am with N&V, chills, fatigue & later in the day diarrhea. Slept off & on throughout the day, drank nothing but Gatorade, Gingerale & water. That night had a temp of 100.8 took Tylenol. Day 4 fever broke able to stomach dry toast & later Chicken Noodle soup but still continued with diarrhea. Day 5 starting to feel a little better, tried to eat normally, but later continued to have diarrhea. From Day 6 to today (Day 12) I still continue to have some nausea & diarrhea & fatigue.
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| 67 | 2021-03-25 | nausea |
The patient reports a severe allergy to Corn/corn syrup. S: I feel itchy and nauseous. I feel like...
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The patient reports a severe allergy to Corn/corn syrup. S: I feel itchy and nauseous. I feel like my chest is heavy. Denies CP or SOB. Denies dizziness or lightheadedness. O: A&O x3. Skin is pink, warm, and dry. No rash. Resp: normal resp rate- no cough no stridor. Cards: RRR in the 80s. Radial pulse palp. A/P: 67 y/o female who reports severe Corn allergy and is having symptoms of s/p Pfizer vaccine that are similar to when she ingests corn or corn derivative. She takes Cetirizine when this happens but does not have any with her. Cetrizine 10 mg po x1 given Patient monitored for 30 min with a resolution of reported symptoms
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| 67 | 2021-03-25 | nausea | Nausea and mild vertigo. Not significant enough to require treatment. |
| 67 | 2021-03-25 | nausea |
fatigue, headache 6 hrs after vaccine (same as 1st dose), ~11 pm, severe chills, nausea, joint pai...
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fatigue, headache 6 hrs after vaccine (same as 1st dose), ~11 pm, severe chills, nausea, joint pain, short of breath ~ 2 am increased heart rate (112, usually in 80's) fever over next 3 days fever, joint pain, injection site redness and area on arm below -day - continued redness in arm
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| 67 | 2021-03-25 | vomiting |
Within an hour of the shot I felt very tired and took a long nap. Around 5 pm I began to feel a lit...
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Within an hour of the shot I felt very tired and took a long nap. Around 5 pm I began to feel a little achy and a slight headache. During the night, I ached all over, had a terrible headache, the muscles in my neck felt like they were drawing up, I had fever, but didn't get up to check it, my joints and bones ached, I had chills and it was a miserable night. The next morning I got up to make my breakfast and I kept trying to pass out and would have to sit down. I was sweating real bad and finally went to lay down. My husband fixed my lunch and I began to feel like my eyes were getting black, and then I slumped over and he said my head was bobbing on his shoulder. I could hear him saying my name, but I couldn't respond. Right after I cam to, I began to throw up at the table. He called an ambulance and they came and check me out. My blood pressure, blood sugar, EKG, and pulse ox were all normal. I refused going to the hospital, but I didn't know what the hospital could do for me. I called my family physician's office, but never heard back from them. I hear the second shot is worse than the first, so I am not sure if I should take the second shot. Also, strangely enough, my arm wasn't sore. Every time I have the flu shot I feel bad for a couple of days. I also felt bad after my Shringrix shot and pneumonia shots.
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| 67 | 2021-03-26 | decreased appetite | Very sore arm, body aches, lack of appetite, and extreme tiredness |
| 67 | 2021-03-26 | diarrhea |
Fevers 104.0-102.6, day 22 and still fevers over 101.0. Severe diarrhea, vomiting, and crushing head...
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Fevers 104.0-102.6, day 22 and still fevers over 101.0. Severe diarrhea, vomiting, and crushing headache since the second vaccine. Vaccine card shows two different Covid vaccines. Nurse wrote in my medical record that I received two of the same, we had witnesses that the second wasn?t a moderna
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| 67 | 2021-03-27 | nausea, vomiting, diarrhea |
Woke up the next morning with body aches, 101 fever, chills, migraine. As the day worn on fever clim...
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Woke up the next morning with body aches, 101 fever, chills, migraine. As the day worn on fever climbed to 103., nauseous and vomiting. Slight headache and diahhrea on 3rd day following vaccine
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| 67 | 2021-03-28 | appendicitis |
Abdominal hematoma; I went to my doctor, he thought it was appendicitis; This is a spontaneous repor...
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Abdominal hematoma; I went to my doctor, he thought it was appendicitis; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Feb2021 (Batch/Lot Number: EN6203; Expiration Date: 30Jun2021) as single dose for covid-19 immunisation. The patient medical history included White blood cell count decreased and tiredness. Concomitant medications included cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) taken for white blood cell count decreased, start and stop date were not reported (taking it for 2-3 months) and folic acid (FOLIC ACID) taken for an unspecified indication, start and stop date were not reported. The patient was hospitalized with abdominal hematoma on 03Mar2021; patient went to doctor, he thought it was appendicitis and should take its course. She was admitted in the hospital from Friday afternoon (03Mar2021) until Wednesday afternoon (05Mar2021). They did a CT scan (03Mar2021), no surgery, they want to see if it would work out, it was rather large, they did blood work, they were very perplexed, they can't understand what happened. They keep asking what she did, although there was no bruising. She did say that she just got her shot. The patient underwent lab tests and procedures which included blood test with unknown result on an unspecified date and computerised tomogram showed abdominal hematoma on 03Mar2021. The patient had a check up on 11Mar2021, hematoma was rather large but the doctors don't know why she got it, she didn't know if it had anything to do with the vaccine. The caller's doctors can't figure it out and she is not on aspirin or blood thinners. There is no reason for the patient to get the vaccine, she did not have trauma and isn't on blood thinners. The patient was told to take 3 vitamins when she left the hospital because she became anemic, she is taking folic acid, vitamin B1 and a multivitamin which she is to take for 10 days to a month. The patient was considered to be recovering from the event abdominal hematoma while outcome of the event appendicitis was unknown.
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| 67 | 2021-03-28 | nausea, vomiting |
something in her throat; rash/bumpy rash; nausea; vomiting; started having a taste in her mouth; tic...
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something in her throat; rash/bumpy rash; nausea; vomiting; started having a taste in her mouth; tickle in her throat, and she kept trying to clear her throat, and then her voice was gone; it felt like her throat was closing up.; rash/red rash; lost of voice; dizziness; headache; This is a spontaneous report from a contactable consumer. A 67 -year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6200, expiration date: 30Jun2021), via an unspecified route of administration on 04Mar2021 (at the age of 67 -years-old), single dose for COVID-19 immunisation. Medical history included diagnosed in 1978 with Gestational Diabetes, and that went away, but it came in 1995 and has been active and progressing ever since; Diabetes, Type Two; allergies to various medications; food allergy. Caller had concomitant medicines of unspecified anxiety medicine, pain medicine,anti-inflammatory, diabetic, blood pressure medicines, the statins. After getting the first dose of the Pfizer BioNTech COVID-19 vaccine, caller had adverse events that made her become hospitalized. She said she had developed dizziness, light headedness, headache, something in her throat, lost of voice, rash nausea, and vomiting. She was in the hospital for 5.5 hours. She originally has the appointment for the second dose of the vaccine on 25Mar2021 but it got cancelled. Caller got the vaccine on 04Mar2021, and the guy gave her the shot, and then said the would check on her in 10 minutes, because of the caller's history of allergies to various medications and foods. Caller reports that she started having a taste in her mouth, and then she got lightheaded, she was dizzy, she got a headache, she felt sick to her stomach and that progressively got worse to where she ended up throwing up twice at the hospital. Caller was given a Bendaryl, and some anti-nausea pills under her tongue, but she did not know she was rashy, until she got home, there was a rash on her chest, arms, back, and legs that was all bumpy and red. Caller started to feel a tickle in her throat, and she kept trying to clear her throat, and then her voice was gone. An ambulance was called, but her husband took her to the hospital because it was right across the street, because her doctor had advised her to get the shot at a site near the hospital because of her history of allergies. Caller reports that she was in the ER for like five and a half hours, and when she started to feel better, she said she wanted to go home and lay in her own bed if she is just going to be puking her guts out. Caller states that she went home and crashed and burned for a few days, with no voice, and she was still coughing to try and clear her throat, it felt like her throat was closing up. Caller confirms she was not admitted to the hospital for this reaction. All events started 04Mar2021. Treatment was given for all events. The outcome of the events was unknown. Caller had no other vaccines on the same day.
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| 67 | 2021-03-29 | GERD, nausea |
Extreme nausea; My symptoms were so severe I felt like I was going to die; I mean literally die; I t...
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Extreme nausea; My symptoms were so severe I felt like I was going to die; I mean literally die; I thought I am going to have a stroke; My chest is still tight; I still feel low congestion; having hard time taking a deep breath; Chills; Headache; The chest pain was horrible; The joint and muscle pain were so severe; I am still little real nauseous; I feel like I mean like acid coming up constantly making me more nauseous; Unable to eat; The joint and muscle pain were so severe; My chest is still tight; I still feel low congestion; having hard time taking a deep breath; My chest is still tight; I still feel low congestion; having hard time taking a deep breath; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Deltoid Left on 19Mar2021 (Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient previously had first dose of BNT162B2 for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication includes supplements and multivitamins. The patient stated "I wanted to ask you and I have some horrible concerns I got my second COVID shot last Friday, and by Saturday night, I am not exaggerating, my symptoms were so severe I felt like I was going to die I mean literally die on 20Mar2021. I couldn't get to emergency room, I figured out I am just going to die, I just laid down and let my door open down so somebody could find me, the symptoms I was having was extreme nausea, chills, headache, the chest pain was horrible, horrible, the headache I mean I thought I am going to have a stroke, the joint and muscle pain were so severe. So I have been taking Tylenol, Advil (Treatment) finally this morning, yesterday was tiny, tiny bit better, this morning its little bit better but I am still little real nauseous and I feel like I mean like acid coming up constantly making me more nauseous and almost like unable to eat. Ever since Saturday all I will have been doing is three bites of chicken soup three times a day. What in the world is going on with this vaccine that it would cause those severe symptoms and my chest is still tight I still feel low congestion having hard time taking a deep breath in Mar2021". The outcome of the event "my symptoms were so severe I felt like I was going to die I mean literally die" was recovered on unspecified date. The outcome of the event unable to eat was unknown. The outcome of the rest of the events was recovering. Information on lot/ batch number has been requested.
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| 67 | 2021-03-30 | abdominal pain, difficulty swallowing |
Sore throat; Headache; Something sharp going down her leg and it felt like it was in the area of the...
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Sore throat; Headache; Something sharp going down her leg and it felt like it was in the area of the vein; Abdominal pain; It is rawish and hard to swallow; Her throat felt scratchy when she laid down; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in upper right arm on 03Feb2021 12:35 (Batch/Lot Number: EN9581; Expiration Date: 31May2021) as SINGLE DOSE for covid-19 immunisation (reported as "her health. She has a heart condition and is scared to get COVID"). Medical history included heart condition (Verbatim: heart condition/caller states she doesn't know what her heart condition is), blood cholesterol abnormal, blood pressure abnormal. Concomitant medications included irbesartan (AVAPRO) taken for blood pressure abnormal (she has been on it for some time); evolocumab (REPATHA) taken for blood cholesterol abnormal (been on it a year. She gave herself a shot yesterday), two heart pills and a blood pressure pill. The patient previously got flu shot back in November. History of all previous immunization with the Pfizer vaccine considered as suspect was None. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. Prior Vaccinations (within 4 weeks) was No. The patient experienced sore throat on 04Feb2021 with outcome of not recovered (reported as worsened), headache on 04Feb2021 with outcome of not recovered, something sharp going down her leg and it felt like it was in the area of the vein on 04Feb2021 with outcome of recovered, abdominal pain on 04Feb2021 with outcome of recovered, it is rawish and hard to swallow on 04Feb2021 with outcome of not recovered, her throat felt scratchy when she laid down on 04Feb2021 with outcome of not recovered. The patient underwent lab tests and procedures which included body height: 152.4 cm on an unspecified date, weight: 165 lbs on an unspecified date. The clinical course was reported as follows: She went and had the vaccine. She got a horrible sore throat. It is rawish and hard to swallow. She had a headache last night (04Feb2021). When she laid down last night it felt like something sharp going down her leg and it felt like it was in the area of the vein: it happened through the night off and on. It hasn't done it today (05Feb2021). She had abdominal pains really bad yesterday(04Feb2021). She didn't have a sore throat prior to the vaccine, so she is sure it is related. Her throat felt scratchy when she laid down. Today (05Feb2021) it has been raw. She has not wanted to eat, but she took her medicine. The headache was just dull at the time of reporting. She had only got the first dose. She only got a sheet with the side effects. 24Feb2021 was when she gets the second. No Emergency Room and Physician Office required. The sharpness down her leg was gone. Other than her throat and dullness in her head she was doing ok. Caller declined to be transferred to a facility. She states she was just going to gargle with warm salt water.
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| 67 | 2021-03-30 | GERD |
pt states she started feeling very bad and everything hurt the day after getting the vax. She has a...
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pt states she started feeling very bad and everything hurt the day after getting the vax. She has a lot of hair loss. She had to stay in the bed for the next couple of days because she had fatigue and body aches. 5 weeks after taking the vax she has swollen lymph nodes in both arm pits and he developed sore knots under the skin on the outside of her thighs. Her BP has become uncontrollable. She was on 10mg of bp medicine and then it was upped to 20 mg. About 7 days ago a diuretic and her BP is still very high. on 3/20/2021 it was 180/89. she checked it again a couple of hours later and it was 165/92. She has had symptoms of GERD since 3/22/2021. Blood work she had on 3/18/21 shows way too much carbon monoxide in her CO2. Her anxiety has increased since she was vaccinated. She has an appt w/ her PCP on 4/9/21. She is very concerned that she is going to die from taking this vax.
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| 67 | 2021-03-30 | nausea, abdominal pain, diarrhea |
also had a headache; her eyes have been really sore, red and she has several broken blood vessels in...
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also had a headache; her eyes have been really sore, red and she has several broken blood vessels in her eyes; her platelet levels dropped; having muscle pain or some kind of pain, maybe joint pain that is in her hips; has had nausea and she has generally felt unwell; muscle pain; she slept for almost two days; felt unwell; diarrhea; abdominal pain; her eyes have been really sore, red and she has several broken blood vessels in her eyes; her eyes have been really sore, red and she has several broken blood vessels in her eyes; tiredness; eyes were yellow when she woke up that morning; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6200), first dose via an unspecified route of administration, administered in Arm Left on 09Mar2021 11:45, single dose as SINGLE DOSE for covid-19 immunisation. Medical history included lung transplant from May2011, immunodeficiency from May2011 and ongoing, strokes. The patient had dtap vaccine before Jan2021. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN); prednisone acetate (PREDNISONE); tacrolimus monohydrate (TACROLIMUS). Patient reported that it has been about a week and a half of maybe more since her first COVID vaccine and she gets new symptoms almost everyday. Most of the symptoms aren't like put-you-down sick, horrible symptoms, they can be dealt with, but she has had a lot of them. She never got injection site pain and her arm never got sore. She had tiredness on the second day after her COVID vaccine, she slept for almost two days. She has a headache almost constantly. She is having muscle pain or some kind of pain, maybe joint pain that is in her hips. She doesn't have chills, a fever, injection site swelling or redness. She has had nausea and she has generally felt unwell all the time for a week and a half now. She is immunocompromised because she has had a lung transplant, that is the one thing that probably sets her apart is that she is immunosuppressed. She had the lung transplant almost 10 years ago now and she has been doing well. She is not on blood thinner medicine but she does take a baby aspirin everyday. Those are the only two things that she can think about. She doesn't know if all of that would make the symptoms from the COVID vaccine different for her. Most people she knows who have received the COVID vaccine have only had a couple days of tiredness and a sore arm. But she has a headache, been achy, and she just doesn't feel good. She also had a headache then and slept a lot, she was really tired. Later in the report caller clarified the first dose was actually 09Mar2021. She is not tired right now but she does still have a headache today, it is a pretty good headache. Her tiredness was Sunday and Monday of this week, confirmed to be 14Mar2021 and 15Mar2021. She says that she has recovered completely from the tiredness even though she feels like she could nap right now but she can't since she has a blood draw later. It is like she wakes up and every day she gets new symptoms. She had two symptoms that are not on the sheet of symptoms. The two she experienced are weird. On Saturday, a week and a day after her vaccine, her eyes were yellow when she woke up that morning. Confirmed date to be 13Mar2021. It was only that one day. She thinks that she has recovered completely. Also, her eyes have been really sore, red and she has several broken blood vessels in her eyes. Some of this is normal in the winter for her, but the yellow isn't normal for her. Normally, when she does get the blood vessels in her eyes they will heal in a day or so but the ones now have lasted much longer. They have been much slower to go away. It is not like there is a red spot, but it looks kind of red and kind of weird. The other symptom that is strange is that her platelet levels dropped. She was at 49 before her COVID vaccine and now her platelet level is down to 29. She does have normally very low levels for platelets but they are usually around 50. They have dropped substantially since her COVID vaccine. They dropped from 50 to 33 and then 5 days later her level went to 29. She is getting another platelet level drawn today, confirmed to be 16Mar2021. Her eyes being sore, red, and having broken blood vessels occurred probably a couple of days after she received the COVID vaccine. Specifically, her left eye felt like it had something in but she doesn't believe that it did. She used eye drops. Her eye just felt gritty. This is not like she had pink eye and she didn't wake up with this eye shut. It wasn't pink eye she knows what that is like. Her eyes had broken blood vessels and then they turned yellow then they turned red and have remained red. They are not sore today and she doesn't feel like she has gravel in her eye but the whites of her eyes don't really look clear. She says so far it has improved some but she will see since she wakes up every day and something new has happened, or something different or something has come back again. The good news is that she doesn't have all of these symptoms at the same time. She can't the remember the day pain in hips began but it is ongoing. She noticed this morning that the pain in her hip was not as bad when she had gotten out of bed. That pain has lessened there but the pain went to her head. Nausea and generally not feeling well: Probed for when this began and caller says that it has occurred for several days after she eats dinner, her stomach will be growling loud and that comes along with abdominal pain which doesn't really fit in with muscle or joint pain, she has no muscle there unfortunately she jokingly says. Sometimes this is all accompanied with diarrhea. It is not ongoing as of now, no date provided. She noticed that it comes and goes and sometimes she can eat and she is fine and sometimes she gets really sick feeling. It seems like if she doesn't eat then she doesn't get the symptoms but she knows that she needs to eat. Investigations: Her doctor has been having her do platelet blood tests about every 5 days since she took the COVID vaccine. She does not remember the dates of these tests off of the top of her head. She had a blood draw at the clinic the day before her COVID vaccine and her platelet count was 49 on 08Mar2021. For the result of 29 that was either last Thursday or last Friday, 11Mar2021 or 12Mar2021. Te outcome of the event scleral discoloration was recovered on 13Mar2021, tiredness was recovered on 15Mar2021, headache was not recovered, pain in hip was recovering, other events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021299104 similar report from same reporter
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| 67 | 2021-03-30 | nausea |
fatigued/ extremely tired; nauseated; severe headache behind my eyes; This is a spontaneous report r...
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fatigued/ extremely tired; nauseated; severe headache behind my eyes; This is a spontaneous report received from a contactable consumer (patient). A 67-Year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EK9231), via an unspecified route of administration on right arm on 25Jan2021 13:15 at single dose for COVID-19 immunisation in hospital. The patient medical history included chronic migraine and brain aneurysm (surgery 2016). Concomitant medications included unspecified Multivitamins (Vitamins NOS) within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jan2021, the patient experienced somewhat fatigued the first day after the vaccine, but the second day It was extremely nauseated, had a severe headache behind her eyes, and was so exhausted that she could barely get out of bed to use the bathroom. she felt better the following day but have since had some days when she is extremely tired. No treatment was received for the events. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient has not been tested for COVID-19 Since the vaccination. The outcome of the events was reported as unknown.
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| 67 | 2021-03-30 | retching |
passing out; she was 155 lbs before when she was in the hospital - and now 160 lbs; States that she ...
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passing out; she was 155 lbs before when she was in the hospital - and now 160 lbs; States that she was dehydrated in hospital and did not eat a thing; stayed dizzy; confused; She had felt disoriented; foggy; it was like the flu shot; sleeping a lot; her vision would get very narrow; thumb pink; erratic body temperature; horrible headache; bodyaches; dry heaves; slight fever/ body temperature 104.4; injection site sore; lymph nodes swollen; This is a spontaneous report from a contactable consumer (patient). The 67-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Right on 04Feb2021 (Batch/Lot Number: EN5318) as SINGLE DOSE for covid-19 immunisation. Medical history included breast cancer - stage 2 from Jan2008; 29Jan2008 surgery, breast cancer. First surgery for breast cancer removal and lymph node removal, then the cancer went around the first and second lymph nodes so they had to go back in because they had to take out a bunch more and she had to give them permission to take out more lymph nodes. Concomitant medication(s) included ongoing simvastatin for High cholesterol; ongoing bifidobacterium bifidum, bifidobacterium longum, lactobacillus gasseri (PHILLIPS COLON HEALTH) she has high pain tolerance, had stomach cramp did not know what it was and one a day vitamin. The patient previously took bnt162b2 (BNT162B2), dose 1 intramuscular administered in Arm Right on 14Jan2021 (Batch/Lot Number: EL8982) as SINGLE DOSE for covid-19 immunization and experienced Injection site sore. The patient experienced passing out on 28Feb2021, injection site sore, lymph nodes swollen on 04Feb2021, thumb pink on 26Feb2021, erratic body temperature, horrible headache, bodyaches, dry heaves on 05Feb2021, she was 155 lbs before when she was in the hospital - and now 160 lbs on an unspecified date. The patient was hospitalized for passing out from 01Mar2021 to 02Mar2021. The event passing out leaf to emergency room visit. The patient lab tests and procedures which included cat scan/ cat scan groin area with contrast: normal; EKG: normal; blood workup: normal; Blood culture:normal, all on 01Mar2021; cat scan head and neck with contrast: normal and cat scan head and neck without contrast:normal on 02Mar2021. The outcome of the event thumb pink was recovering, erratic body temperature was not recovered, horrible headache, bodyaches, dry heaves recovered on 26Feb2021, and was unknown for the rest events. Reported as: Caller states that on 04Feb2021 she received her 2nd vaccine at around 3:30 pm, and then around 10 pm she had injection site soreness. The morning after the second injection around 4 am, she had site on her arm soreness, erratic body temperature with slight fever, horrible headache, bodyaches, and dry heaves. Her lymph nodes also swelled up again. Caller clarifies that this also happened after her first injection of the Pfizer Covid19 vaccine and on a similar timeline. Caller clarifies that 2 weeks later on 26Feb2021 she had ended up with horrible headache, dry heaves, headache, body temperature 104.4. She states that this lasted Friday night and Saturday night and Sunday she was feeling better. Clarifies that was the week of 26Feb2021. Caller states that her events were on a similar timeline and that her first vaccine was 14Jan2021 at 3:30 pm on Thursday. States that by 10 o'clock that night, injection site was sore. At 4 am, injection site was very sore. A couple of days later, her lymph nodes were swollen in her left leg, groin area, right arm under armpit. Adds that area under armpit was the size of her thumb. Also, on the left underneath her chest wall. She states that she has had breast cancer in that left breast. She states that the swelling went away completely, but that the groin area swelling took 2 weeks to go away. Unable to verbalize exact dates. Confirms that this was after the first vaccine and also occurred after the second vaccine. Caller then adds that she was feeling better Sunday, 28Feb2021 but that her husband then found her on the floor Sunday night at 8:45 pm. She states that she passed out. Monday she passed out again and was taken to the hospital where she stayed until 02MAR2021. Healthcare Provider also provides information that her son ran her to emergency room, and she is not familiar with the doctors there. Also, a doctor that she does not remember the third physician but it was a neurologist. Caller states that she was 155 lbs before when she was in the hospital - and now 160 lbs. States that she was dehydrated in hospital and did not eat a thing. Normally she runs around 160 lbs. States she had breast cancer so left arm cannot be used, so they used her right arm for both vaccines. caller adds that she had a cruise she was going to go on but refused to go on in 2020. States that she heard you will need to have a vaccination passport to travel in the future so she wanted to get vaccine. States she did not want to get covid. States that so many people have died. Caller clarifies that she was admitted to (Hospital Name) on 01Mar2021. Caller adds that she went to the hospital 2 weeks after the second dose. She states that is what makes them wonder if it is from the Covid vaccine. Adds that she is not saying that is what caused all of this, but that it is just a coincidence that it was exactly 2 weeks after the vaccine, exactly 2 weeks out when this happened. She states that she has been thinking if she should be wasting Pfizers time reporting this but it could be a coincidence or maybe a reaction. Caller adds maybe it is because she had 34 radiations, 8 chemo treatments, 1 year of Herceptine, and breast cancer. States that maybe she can save somebody else, or if a possibility, people can be prepared two weeks early. She adds that she is lucky she did not break an arm, leg. or bone. States that she doesn't know if maybe she can save some other person by sharing this information. Injection site sore: States that this was after both first and second vaccine. It stayed sore for about a week, and was just tender after that. If she touched it, she noticed, but it didn't hurt her from doing anything. With the first vaccine, injection site soreness started 14Jan2021 around 10 pm and completely resolved after about a week. She adds that with the second vaccine she also noticed injection site soreness that same day on 04Feb2021 around 10 pm also. She adds that it lasted about six days or seven days or so. It was the same way, tender the first day and then at 4 am was when it got really bad. That Friday 05Feb2021 was when it hurt worse. Adds that she went into hospital on 01Mar2021 on Monday. States she was feeling okay, stayed dizzy and confused and thought she was getting Alzheimer's or dementia but it cleared. At 11 pm on Sunday felt completely different, like the old her. States she was fine yesterday 15Mar2021. She had felt disoriented but is now feeling better and back to normal. Eratic Body Temperature: States that she started watching and recording her body temperature on 09Mar2021. She states that it was 104.5 on Friday, and Saturday and Sunday night she used a wet washcloth to her forehead. States that her body temperature initially was variable starting on 26Feb2021. She adds that it continued until Sunday 28Feb2021. On 26Feb2021, her body temperature was 104.5. She states that it was then low on Sunday 28Feb2021 and was 98 or 99. Adds that it had been erratic but that once the fever broke it has been between her normal which is 98.6 to 98.7. Adds that her and her husband know for sure that when she passed out the three times, her temperature was 94.4. States that her husband gave her aspirin for the temperature. Adds that her temperature has been between 97.9 to 94.9 and dropped to its lowest on Saturday 13Mar2021 at 10:35 am. She states that it is still doing this erratic behavior and that this morning it was 96 at 1 am and then 96.8 at 8 am. While on phone today, it is 97.1. Lymph nodes swollen: States noticed swelling at 4 AM 16Jan2021. States this occurred 4 am after both first and second injection. Occurred to groin area, right arm, and left arm. It was there for a couple of days and then it would just remind her it was there. The arm lymph node swelling went away after a few days, maybe before a week or so. The one in the groin was there for about two weeks. On a scale of 1 to 10, it was a 1.5 and was not something that people need to take an Advil or something for. Clarifies it was in the armpit except in the left side because they took those lymph nodes out during surgery in 2008. Also, she noticed lymph node swelling in the chest area. Lymph Nodes at second vaccine she also noticed them starting at about 4 am after the vaccine and it started hurting again. Caller reiterates both shots were given at 3:30 pm and then at 10 pm injection site gets sore.Then 4 am injection site gets more sore. She's been telling everybody to get the vaccine in the morning. Her symptoms lasted two weeks and then she was fine. Caller adds that her husband never felt a thing from receiving the vaccine. She states that the injection site was tender on her husband but gone the next day. Investigations: stated they looked at her in the hospital and said she was fine. The girl came back up and did more cultures and nothing grew. They were confused and so was she and she has been debating whether to call and waste time reporting but thinks that Pfizer needs to know what happened to her. Simvastatin: Adds that asked doctor if this caused her symptoms and he said no. Phillips colon: doctor 6 to 9 months later did scan, the next day was in emergency surgery and it was her appendix. It enlarged and had grown into the other organs. Doctor said it was a mess and it was ready to rupture as a precaution they wanted to remove it. Bayer product Code above expiration date states 0C09C and expiration is Mar2023. Thumb pink: thumb nail to finger print past where you bend it was where she noticed it was pink. States it is now 98% better. Friday 26Feb2021 afternoon at 1 pm, right thumb turned pink. She took a pen and marked where it was vertical and horizontally pink to scarlet in color. She put herself on antibiotics. She was not sure if maybe she cutting chicken and cut it, or closed finger in drawer. It swelled up twice the size, turned purple. Went all around the finger and it was hot. She thought it was going to pop off. She kept wondering what she was going to do to her thumb. She did jam it and cut herself 2 months ago. Clarifies it was right hand thumb. Treatment: took antibiotics, which she states they kept her on in the hospital in IV form. She started the antibiotics on Friday 26Feb2021. Took it Friday afternoon, Friday night, and Saturday and Sunday. She thought it was doing better Sunday night before she passed out. Clarifies Cephalexin, 500 mg daily (Keppra) three times a day and by mouth. Adds that she keeps this medication on her because she travels the world and it is good to have on hand since it is broad-spectrum. Passing out: 28Feb2021 Sunday night noticed the volume on television was driving her crazy and it was irritating. Around a quarter to 9 she got up to brush her teeth and go to the bathroom. She went pee and then fell off toilet. She got really really dizzy, and her husband was standing over her yelling asking what happened. She saw the wall and she did not know what happened. States she was out cold and he was calling her name but she did not hear him. She heard him asking what happened but it was in the distance. He got her to bed and about 20 minutes later (husband reports 30 minutes later) she was so dizzy and passed out again. She adds that this may have happened Saturday also because she was sleeping a lot and it was like she was seeing words repeat themselves over and over again and her vision would get very narrow. Her husband was note sure if she passed out on Saturday also, but said both times Sunday she was out cold. Monday 01Mar2021 she called her husband's office and woke up to the nurse on the other line screaming. She dropped the phone and heard her name being screamed over and over on the phone and when she picked it up the nurse said that she must have passed out even though she thought she was sleeping. The nurse got ahold of her husband in his office. She believes she passed out again Monday morning and was then in the hospital Monday and Tuesday. Hospitalization: On 01Mar2021, her husband is a physician and suggested she go to the hospital. She was trying to get ahold of her son and daughter in law. She sent them a text and called and they did not answer. Her sons phone was charging and when he looked at it he was on his way to her. She states that when she came to all three times, she was extremely dizzy foggy and confused. Adds that the nurse at her husband's office alerted her husband and he told her to stay in bed and her son came to help her and then drove her to ER. States she was there Monday 01Mar2021, and discharged Tuesday night 02Mar2021 about 4:30 to 6 pm. Caller does not want to file a report for her husband regarding the injection site soreness. She states it was like the flu shot. She clarifies that it was not his arm, it was the injection side. She states that these people who are going on and on about their arm hurting, it is the injection site. She states it is the injection site and will not be the arm. States that it is like the flu shot. States she does not want to file a report regarding her husband because it was injection site soreness and went away. Provides no additional information. Adds that this is a new drug and new disease and we do not know what the future holds Caller adds that she keeps a diary and started a diary so that she has everything recorded in terms of medical history. States that it is important that everybody do so. Family Medical History Relevant to AE(s): callers dad passed out at age 85. He found out he was diabetic and had heart issues. Also had a stroke at age 87 and passed away. Adds that between ages 85 and 87 he passed out every few months, he would do one of his passing out things. Caller also had a brother who passed out sitting at table and went forward into table. She states at that time her brother didn't realize he had stage 4 lung cancer, and her brother passed away 1 and a half years later. Caller adds that he smoked from ages 15 to 64, and quit at age 63 because the doctor told him to. No follow-up attempts possible. No further information expected.
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| 67 | 2021-04-01 | appendicitis |
Appendicitis, 27 days later; This is a spontaneous report from a contactable consumer (patient). A 6...
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Appendicitis, 27 days later; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EN6200), via an unspecified route of administration, administered in Arm Left on 23Feb2021 13:15 at 67-year-old as single dose for COVID-19 immunization. Medical history included allergies: Cephalosporins. Patient is not pregnant. Facility type vaccine: Public Health Clinic. Patient had no Covid prior vaccination. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (lot number: EL9265) on 29Jan2021 12:30 at 67-year-old on left arm for COVID-19 immunization. On 18Mar2021 02:00, the patient experienced appendicitis, "27 days later". AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for appendicitis, 27 days later for 1 day. The patient underwent lab tests and procedures which included Nasal Swab: negative on 19Mar2021. Therapeutic measures were taken as a result of appendicitis, 27 days later (Surgery). The outcome of the event was recovering.
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| 67 | 2021-04-12 | difficulty swallowing |
Glands in her throat swelled up; her throat was inflamed; Painful to swallow; Throat pain, sore; her...
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Glands in her throat swelled up; her throat was inflamed; Painful to swallow; Throat pain, sore; her neuropathy, since the vaccine, has acted up.; her neuropathy, since the vaccine, has acted up.; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in upper left arm on 15Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation (did not want to get Covid). Medical history included hypertension (she has been on medications for it, and she doesn't know how long), Cancer (Cancer Survivor. for probably 8 years), ongoing Neuropathy (since she had chemotherapy 7.5 years ago), chemotherapy. Concomitant medication included telmisartan tablet at 80 mg once a day taken for hypertension (stated she has been taking it for a couple of years). The patient experienced her neuropathy, since the vaccine, has acted up on an unspecified date in 2021, glands in her throat swelled up on 20Mar2021, her throat was inflamed on an unspecified date 2021, painful to swallow on an unspecified date in 2021, throat pain, sore on an unspecified date in 2021. Caller stated she was the recipient of the Pfizer vaccine. Caller stated her first shot was 15Mar2021, and in 5 days, all of a sudden her glands in her throat swelled up, and asks, is that normal, Reclarified, caller stated the Pfizer vaccine, she was not sure but as she gets older, she shrinks. Caller stated that she was due to get her second shot next week and was a little leery. Glands in throat swelled up: Start: caller stated she did not know than stated 20Mar2021, she thought. Stated it was resolved, she did not feel it, it resolved 2-3 days later, maybe on the 23Mar2021. Caller stated it was weird, her throat was inflamed and it was painful to swallow. She did not know, it was hard to tell, it feels a little sore. Caller stated she did not know she has no idea. Throat inflamed caller did not the same day, maybe that Saturday, or the night before, she did not remember. She reports she did a lot of gargling with salt water and her throat was sore, what the heck. She stated she feels much better. Recovered. Caller stated she did not remember. In 2021, painful to swallow caller Stated probably the same day as the glands or the night before. She Stated no, it was not difficult to swallow anymore. She did not know the end date, it was better 3 days later. Throat pain and sore in 2021, caller stated no, it was all together around the same time. Caller stated she woke up with it. Caller stated the pain has gone, and she did not know the date, once it went away, she didn't think about it. She was not sure, if it was recovered, or recovered completely. Caller stated she has neuropathy because of chemotherapy, but reports that her neuropathy, since the vaccine, has acted up. Stated the vaccine must have been given between 1 and 1:30, she had the appointment at 12:45, but didn't get in after 1:00. Caller stated all she saw was N534, she thinks, it was an E or Z the way that they wrote it. Caller gave ZPN534, reclarifies, she stated she thinks they wrote it so sloppily.. She did not know if that was an E or ZPN534. I was having hard time reading it. It could be a E or it could be a Z, P, I think it was N 534. For events, her neuropathy, since the vaccine, outcome was not recovered, glands in her throat swelled up, outcome was recovered on an unspecified date in 2021, her throat was inflamed outcome was recovered on an unspecified date in 2021, painful to swallow, outcome was recovered with sequelae, throat pain, sore outcome was recovered on an unspecified date in 2021. Information on the lot/batch number has been requested.
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| 67 | 2021-04-17 | nausea |
Chronic obstructive pulmonary disease exacerbation; hypertension; vaccination complication; really s...
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Chronic obstructive pulmonary disease exacerbation; hypertension; vaccination complication; really sick; nausea; headache; The patient had decreased breaths from 12 to 10 breaths; This is a solicited report received from pharmacy. A contactable other healthcare professional and a consumer (patient) reported that a 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as a single dose for COVID-19 immunization; treprostinil sodium (TYVASO, concentration of 0.6 mg/ml), resp inhalation (reported as via inhalation (IH) route) from 23Sep2020 (batch/lot number: 2101929; expiration date: 31Jan2022) to an unspecified date, delivered by Tyvaso inhalation device (TD-300/A) at 18-54 ug, QID (3-9 breaths), then via an unspecified route of administration from an unspecified date (batch/lot number was not reported) to an unspecified date, at 72 ug to 60 ug (12 to 10 breaths) for secondary pulmonary arterial hypertension. Medical history included ongoing secondary pulmonary arterial hypertension and ongoing chronic obstructive pulmonary disease. Concomitant medication included tadalafil taken for an unspecified indication, start and stop date were not reported. On 25Mar2021, the patient experienced events of chronic obstructive pulmonary disease exacerbation (chronic obstructive pulmonary disease, hospitalized), hypertension (hypertension, hospitalized) and reaction to COVID vaccine (vaccination complication, hospitalized). On an unreported date, the patient experienced events of really sick (illness), nausea (nausea) and headache (headache). On an unreported date, the patient had decreased breaths from 12 to 10 breaths (off label use). It was also reported that the patient had decreased breaths from 72 ug to 60 ug (12 to 10 breaths). The patient was really sick, nausea and headache. On 25Mar2021, 6 months and 3 days after initiating IH Tyvaso, the patient was hospitalized for reaction to coronavirus disease (COVID) vaccine, chronic obstructive pulmonary disease exacerbation, and hypertension. The patient was discharged from the hospital on 28Mar2021. The action taken in response to the events chronic obstructive pulmonary disease, hypertension and vaccination complication for treprostinil sodium was not reported, and dose was decreased due to the events illness, nausea and headache. At the time of reporting, the outcome of chronic obstructive pulmonary disease, hypertension, vaccination complication, illness, nausea and headache was unknown. The reporter did not provide causality for the events of chronic obstructive pulmonary disease, hypertension, and vaccination complication. The reporter's causality for the events illness, nausea and headache with IH treprostinil sodium was considered to be possibly related. Case Comment/Sender's Comment: The company has assessed the serious adverse event of chronic obstructive pulmonary disease, hypertension and vaccination complication as not related to IH treprostinil and TD-300/A device. Chronic obstructive pulmonary disease and hypertension were likely due to exacerbation of underlying COPD and Hypertension respectively. Vaccination complication was due to COVID vaccine. The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is based on the company causality assessment. Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event chronic obstructive pulmonary disease, hypertension, vaccination complication, illness, headache, nausea and the suspect drug BNT162B2 , TYVASO cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 67 | 2021-04-19 | abdominal pain |
Pt presented with abd pain, dark stool, altered mental status, febrile, hypotensive, septic, cardiog...
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Pt presented with abd pain, dark stool, altered mental status, febrile, hypotensive, septic, cardiogenic shock, progressed to multi organ dysfunction.
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| 67 | 2021-04-24 | indigestion |
face swelled up, numbness and red on left side; face swelled up, numbness and red on left side; sinu...
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face swelled up, numbness and red on left side; face swelled up, numbness and red on left side; sinus infection; Shortness Of Breath; pounding in my chest/throbbing in her chest; ringing in ears; flared up some digestive issues / digestive disturbances; flared up some digestive issues / digestive disturbances; red on left side/face redness; exhausted all the time; This is spontaneous report received from contactable female consumer (patient) reported herself. A 67 years old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6199) on 10Mar2021 17:30 at age of 67 years old at single dose in right upper arm for COVID-19 immunisation. Medical history included: last year February, she was really sick with bad sinus infection not knowing about COVID at the time. Sometime later she got these horrible digestive attacks, ended up in her stomach and esophagus, horrible attacks where she couldn't breath, she has had acid reflux in the past. digestive problems stayed with her a really long time, they did and endoscopy and put her on amitriptyline 10mg daily, continuing to take this medication for hypersensitivity. She tested in April last year, it was negative (not detectable). There was no history of all previous immunization with the Pfizer vaccine considered as suspect. Concomitant medications were not reported. No additional vaccines administered on same date of the Pfizer Suspect. No prior vaccinations (within 4 weeks). No adverse events (AE) following prior vaccinations. Patient had first Pfizer covid vaccine on 10MAR2021, approximately 10 days to 14 days after the vaccine her face swelled up, numbness and red on left side, went to see my doctor, he treated her with steroid and antibiotic for sinus infection, at the same time she had some shortness of breath and pounding in my chest, and had and still have ringing in ears since then, it kind of flared up some digestive issues she had last year. If she back up to last year February, she had a bad sinus infection, went to see allergist, family doctor and ENT, all treated her for sinus' before covid testing was even a thing, they didn't think of covid testing at the time. It ended up in her stomach and esophagus, horrible attacks where she couldn't breath, they did and endoscopy and put her on amitriptyline 10mg daily, continuing to take this medication for hypersensitivity. In March2020 her husband came home with covid, after that, talking to his doctor, she brought him meals outside of the door, it occurred to her that queried if this could have been covid. She tested in April last year, it was negative (not detectable), they were still not sure if it could have been covid. She was supposed to get the second vaccine, she postponed it, the numbness and swelling of face is gone, next shot was tomorrow. Since this was a delayed reaction, typically one to three days would be a reaction to the vaccine. she didn't associate it with the vaccine, asked if it could have been from the vaccine. She wanted to make sure that she was safe to get the second one. Response: Spoke from EUA factsheet for Recipients and Caregivers: LAB-1451-4.0 Revised: 06 April 2021: Sections: who should not get the PFIZER-BIONTECH COVID-19 VACCINE and what the risks of the PFIZER-BIONTECH COVID-19 VACCINE were. Spoke from attached VR Consumer- Pfizer cannot assess causality (i.e., cannot assess if what you described/are experiencing is associated with the Pfizer BioNTech Covid 19 vaccine). Your doctor/healthcare provider is in the best position to assess and advise you as your doctor/healthcare provider is most familiar with your medical condition, clinical history, how your treatment has been conducted and any relevant information to your specific case. Patient calling about the COVID vaccine. She states that she had the first vaccine 10MAR2021, and 10 days afterwards her face swelled up. She had numbness in it and redness. She went to the doctor and the doctor thought that maybe it was a sinus infection. So she was treated for that. She states that she did have a few other symptoms. To make a long story short, she was suppose to have the last vaccine last Friday. She postponed it for a week (postponed getting the second shot for a week). She wants to know what Pfizer thinks about her getting her second vaccine and her side effects. She says that somewhere between the 10th and 14th day, after receiving the vaccine the symptoms started and that was why she did not think she had a reaction to the vaccine. She has not had anything like that before, it was sort of a delayed reaction. She states she is better now. She had a few symptoms after the face things started and the only thing that she still has now is ringing in her ears. She states it all started around the same time as her face issues, or might have started a little after that. She confirms everything but ringing in her ears have completely resolved. She states that she did have some digestive disturbances, shortness of breath, and throbbing in her chest after receiving the vaccine. She asks if she can go back a little bit to explain. She states that last FEB2020 she was really sick with bad sinus infection not knowing about COVID at the time. She went to her allergist, then her family doctor, and then an ENT. She states that it was nothing like she has ever had, it was really bad. Sometime later she got these horrible digestive attacks, she has had acid reflux in the past but it was nothing like this. In March her husband had COVID and tested positive for COVID. She decided to get tested and she tested negative. She wonders if she had COVID earlier but at that time they were not testing for COVID. Her digestive problems stayed with her a really long time, and she was still on the medications her gastrointestinal doctor put her on. They are hypersensitive esophageal medication. She states that she has been exhausted all the time. The rest of the story she has told already. She states that after the face thing happened she started getting those digestive issues again. Her friend suggested that she call Pfizer, so she is doing that. She confirms that the vaccine card does not have an expiration date, NDC, or dosing information. She states it says 0.3 ml, but she cant see a point, so she doesn't know if its just 03. She states she got the vaccine to lessen her chances of getting a severe disease, in case she ends up in the hospital. Also, to keep herself safe from other people. She states she wants the second one because husbands works with the public and she wants to be protected when he comes home. She states that she has those gastrointestinal disturbances and is on amitriptyline 10 mgs for that. She states she also takes something for her thyroid but she has no major health issues. She states that she had a endoscopy and a colonoscopy as well as blood work done but she doesn't have any of the results because they are in her Beaumont chart where she actually got the vaccine. All of this was pre-vaccine so she doesn't know how relevant it is. The patient did not require a visit to Emergency Room, but visit to Physician Office. The only thing similar had a sister who reacted to a shingles vaccine, She has no information about her sisters reaction to the vaccine. Outcome of event ringing in ears was not recovered, for others was recovered. No follow-up attempts are needed. No further information is expected.
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| 67 | 2021-04-24 | difficulty swallowing |
Losing voice, like Laryngitis; Chest was heavy; Red spots on arm; Losing voice, like Laryngitis; Har...
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Losing voice, like Laryngitis; Chest was heavy; Red spots on arm; Losing voice, like Laryngitis; Hard to swallow; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left, 2 inches below shoulder on 31Mar2021 14:45 at the age of 67-years-old (Lot Number: EP7533) as single dose for covid-19 immunisation. The patient medical history included Covid in January in an unspecified year and underlying health issues. Concomitant medication included diphenhydramine hydrochloride (BENADRYL). The patient had adverse reactions to some medications, she did not know the names of the medications. On 31Mar2021, the patient experienced hard to swallow after she had the shot about 15 minutes at 3 p.m.; losing voice 20 minutes after the shot, chest was heavy and red spots on arm about 20 minutes after the shot. The patient stated she went to the emergency room where the doctor gave her 50mg of diphenhydramine hydrochloride and she tought some type of stomach pill. The patient stated she fell asleep for an hour and when she woke up, her chest was not heavy and she could swallow better, reclarifies that, her voice, felt like she had some laryngitis. The patient stated she had an appointment on 28Apr2021. The patient stated that she talked to the provider about taking the second vaccine, and her doctor told her to take the diphenhydramine hydrochloride before the she got the vaccine. She would have had the second vaccine by the time of her next appointment. The events outcome was recovered on 31Mar2021. No follow-up attempts are needed. No further information is expected.
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| 67 | 2021-04-24 | nausea |
cramps; her stiff neck; She couldn't move her neck, it was very painful; She was breaking out in swe...
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cramps; her stiff neck; She couldn't move her neck, it was very painful; She was breaking out in sweats; She is still cold/She is freezing cold; She is loosing her hair. clumps of hair falling out.; sinus headache; had issues with her thyroid; sinusitis like when she had COVID; palpitation; nausea; feeling achy like you have a flu/ aches and pain; fever; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received first dose of BNT162B2, via an unspecified route of administration, administered in arm left on 26Mar2021 15:00 (Lot Number: EN6208) as single dose for COVID-19 immunisation. Medical history included atrial fibrillation on an unknown date. Caller added she takes medication for Atrial Fibrillation. She had Covid at the end of Dec2020. She was sick and out of work for 6 weeks. She had a headache since she was diagnosed with Covid. Caller had a funny sensation in her sinuses after the injection. It was a weird feeling, just like when she had Covid. She had breathing issues with her Covid diagnosis. Her headache, cough, and breathing issues kept her out of work for 6 weeks. She had a lot of allergies. The patient's concomitant medications were not reported. The patient experienced headache on 26Mar2021 with outcome of recovered with sequelae on 27Mar2021, achy, chills, fever, nausea on 27Mar2021 with outcome of recovered with sequelae on 29Mar2021, palpitation, sinusitis like when she had covid, cramps, stiff neck, couldn't move her neck, it was very painful, she was breaking out in sweats, still cold/ freezing cold, loosing her hair/ clumps of hair falling out, sinus headache and had issues with her thyroid on an unspecified date with outcome of unknown. The clinical course reported as follows: Patient had the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE last 26Mar2021 and scheduled to get the 2nd dose on 16Apr2021. Patient experienced headache, sinusitis like when she had COVID, nausea, feeling achy like you have a flu, fever chills, cramps ,aches and pain, palpitation. Patient had tested positive for COVID last 28Dec2020 that lasted for 6 weeks. Asking if 2nd dose will be more intense when it comes to reactions and if she can safely have the 2nd dose. She will see her cardiologist due to chest palpitations. She worked and had her first Pfizer Covid-19 vaccine 26Mar2021. She had Covid at the end of Dec2020. She was sick and out of work for 6 weeks. She had a headache on Friday immediately after her injection. Then was okay. On Saturday morning after waking up, she felt achy, nauseous, had a fever, chills, and a headache. On Sunday she was not feeling great. Even into Monday, she had fever and chills and felt the same as when she had Covid. Caller added she is not supposed to get sick. Caller states weighs 160 pounds, which she shouldn't be. After the shot she felt a sinus headache. Funny sensation in her sinus's just like it was when she had COVID. Once she had the shot, the original headache went away along with her stiff neck. She couldn't move her neck, it was very painful, it still happens. And she had breathing issues with her Covid diagnosis. Her headache, cough, and breathing issues kept her out of work for 6 weeks. Caller had lasting effects from Covid, but didn't know if these symptoms were related to the shot. She was breaking out in sweats. She was still cold. There was something going on. She was having her Vitamin D level and thyroid checked. She was loosing her hair, clumps of hair falling out. She had issues with her thyroid. Caller wondering if the vaccine was the cause. She was freezing cold. She hadheart palpitations and was seeing her Cardiologist next Thursday. Caller received the vaccine because she had Covid and didn't want to get it again. She was pretty sick. She worked around people and didn't want to be in a situation because not everyone wants to get the vaccination. Treatment of events included: She had not been to the doctor for this, she just jumped into bed and took Tylenol. The events didn't require a visit to emergency room or physician office. No follow-up attempts are needed. No further information is expected.
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| 67 | 2021-04-24 | nausea |
Shaky; Muscles and nerves seemed to be locking up like almost paralyzed; swollen lymph nodes; inject...
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Shaky; Muscles and nerves seemed to be locking up like almost paralyzed; swollen lymph nodes; injection site redness; severe allergic reactions; slight dizziness; severe headache; nausea; weak; tired; feverish; sweat; had pain at the Pfizer Covid 19 Vaccine injection site; right arm started to swell; chills; extreme muscle pain; certainly extreme and joint pain; Heart beat seemed to speed up; Has not been able to walk or move body in normal fashion; This is a spontaneous report from a contactable consumer (patient herself) A 67-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EP7533) a week ago via an unspecified route of administration on 02Apr2021 at 13:45 hrs on the right upper arm as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.When caller was 18 they required a booster for Small pox and caller received the small pox booster on the leg in the same site where it was given at age 5. Caller's leg swelled up to 5 times the normal size, at the time caller was 18 years old.Took a long time for swelling to go away, a couple weeks. Caller requires it hindered sports activities during this time. On 02Apr2021, the patient started reported slight dizziness, severe headache, Shakiness, nausea, weakness, tiredness, have been feverish, pain at the injection site and stated that her right arm started to swell. The patient stated that through out the night of 02Apr2021, she had extreme muscle pain, certainly extreme and joint pain that was also extreme and heart beat seemed to speed up within the first hour and by the end of the hour. On 03Apr2021, the patient stated that her muscles and nerves seemed to be locking up like almost paralyzed. The patient described the events she experienced slight dizziness and didn't worry because it wasn't major and caller was driving herself and with in an hour the dizziness got worse. Caller had severe headache and had to drive home a significant distance and the time the caller got home, she reports being shaky, dizzy, had headache, nausea, was weak and tired and must have been feverish. Caller reports she must have been feverish because she was drenched in sweat by the time she got home and it was a 2 hour drive home from the vaccine administering facility. Caller had pain at the Pfizer Covid 19 Vaccine injection site, and caller's right arm started to swell.Caller clarified that the injection site was in the right upper arm, doesn't know what the muscle is called. Caller says she couldn't see if her arm was getting red, caller has some discs out in her neck and is unable to look at the arm. Caller could feel the injection site on her right arm was swollen and swelling. Caller reports fever was gone and fever got replaced with chills later on. Caller reports there was progression of the symptoms after the first hour. Caller states the information provided thus far was the first hour of her experience and through the night a lot of other things changed and added.Through the night caller had extreme muscle pain, certainly extreme and joint pain that was also extreme. Muscles and nerves seemed to be locking up like almost paralyzed: By the next morning, after caller had the Pfizer Covid 19 Vaccination, states she was not a doctor but all of her muscles and nerves seemed to be locking up like caller was almost paralyzed. Caller reports she couldn't move, couldn't get out of bed. It took a long time to get caller's fingers and toes moving and the rest of the body, but fingers and toes were the first ones. Caller was able to kind of release from muscle cramping. Whatever was going on, caller says can't tell exactly what was going on, does not have a Doctor in the home. States the information given should cover that part of the experience. Through the night had extreme muscle pain, certainly extreme and joint pain that was also extreme: Reports since the morning after receiving the Pfizer Covid 19 Vaccine, caller has had continued muscle pain, although not as extreme, its pretty extreme, and join pain. The patient has not been able to walk or move body in normal fashion. The patient stated that she had every side effect listed on the fact sheet at the top minus the swollen lymph nodes and injection site redness and she had two of the side effects listed under the severe allergic reactions. The patient wanted to know whether it is safe to receive the second dose of the vaccine. The patient lives in an isolated area where all through COVID-19 she tried to get information from the local medical clinics and they did not seem to stay informed. Caller states she has a doctor's appointment, and she will let them know the side effects she experienced after the first dose but she is not confident in the recommendations they might provide. Patient was given a list of side effects to look for, ones they were assuming, doesn't know if the hand out was published by Pfizer or not.The hand out listed emergency kind of side effects people were experiencing.Caller reports they are over age 65 range and knew a lot of people before her who had the Pfizer Covid 19 Vaccine and said they only had injection site soreness. Caller was expecting the same reaction, caller was told by the Doctor she was in pretty good shape. Caller reports she had most all of the reactions except anaphylactic reaction of not breathing after receiving first dose Pfizer Covid 19 Vaccine. Caller is nervous about going for the second round of the Pfizer Covid Vaccine, is not sure how to proceed and would like that information. The case was assessed as serious medically significant for the event paralysis. It was reported that patient took Aspirin as treatment medication for pain. The outcome of the events was resolved for fever and nausea, resolving for swelling arm, unknown for swollen lymph nodes, Chills , Vaccination site pain, injection site redness, severe allergic reactions, sweat, shaky feelings, heartbeat increased, movement disorder and not resolved for all other events.
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| 67 | 2021-04-26 | diarrhea | Diarrhea, joint aches, chills |
| 67 | 2021-04-26 | vomiting, diarrhea, nausea |
hot and cold; very ill; felt horrible; Clammy; feeling odd, kind of wonky, woozy; Diarrhea; Fall; pr...
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hot and cold; very ill; felt horrible; Clammy; feeling odd, kind of wonky, woozy; Diarrhea; Fall; pretty badly bruised / bruise has gone above her knee to her ankle; Weak and could not get out of bed; Sleeping a lot; Dizziness; Headache; Chills; Vomiting; Queasy; This is a spontaneous report from a contactable consumer reporting for herself. A 67-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 16Mar2021 11:05 (Batch/Lot Number: EP7534; Expiration Date: 31Jul2021) as single dose for covid-19 immunisation . Medical history included hypersensitivity , immune system disorder , respiratory disorder , cytogenetic abnormality , endocrine disorder Endocrine abnormalities , diabetes mellitus , obesity , anxiety, hypersensitivity. Concomitant medication(s) included alprazolam (XANAX) at 5 mg daily, taken for anxiety, start and stop date were not reported; duloxetine hydrochloride (CYMBALTA) at 60 mg daily taken for anxiety, start and stop date were not reported. The patient experienced fall on 05Apr2021 with outcome of recovered with sequelae , pretty badly bruised / bruise has gone above her knee to her ankle on 05Apr2021 with outcome of unknown , headache on 16Mar2021 with outcome of recovering , chills on 16Mar2021 with outcome of not recovered , vomiting on 16Mar2021 with outcome of recovering , queasy on 16Mar2021 with outcome of not recovered , diarrhea on an unspecified date with outcome of recovering , weak and could not get out of bed on 17Mar2021 with outcome of recovering , dizziness on 16Mar2021 with outcome of not recovered , sleeping a lot on 17Mar2021 with outcome of not recovered , hot and cold on an unspecified date with outcome of unknown , very ill on an unspecified date with outcome of unknown , felt horrible on an unspecified date with outcome of unknown , clammy on an unspecified date with outcome of unknown , feeling odd, kind of wonky, woozy on an unspecified date with outcome of unknown. The events fall and contusion were considered Important Medical Events. The remaining events were non serious. No follow-up attempts are possible. No further information is expected.
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| 67 | 2021-04-27 | diarrhea, abdominal pain lower |
multiple er/admissions from february through april 27. pt deceased on 4/27/21 2/25/21 known past m...
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multiple er/admissions from february through april 27. pt deceased on 4/27/21 2/25/21 known past medical history of hypertension and hypothyroidism. Status-post spinal decompression due to stenosis. The patient then developed worsening issues with a surgical site infection. Patient has had numerous bouts of C diff. Staff notes patient is to have GI consult in the near future. Patient is seen today in her room. Patient was once again diagnosed with C diff and is currently being treated with antibiotics. Patient notes no bowel movements today. Patient has not had any issues with intake recently. The patient's weight has declined partially due to likely diarrhea. Patient's blood pressure continues to be monitored closely as it has been on the lower side of normal. Patient's potassium 2.9 on CMP. Patient's other care and therapies were reviewed. 2/28/21 Patient was admitted the hospital after found to be anemic at skilled care facility where she is being treated for C diff infection recurrent Lea. Patient was transfused. Patient was also found to have pneumonia/lung mass. Patient has struggled with electrolyte dysfunction. Patient had to be transfused a second time. Patient did well with second transfusion. Patient was found to be hypokalemic. Patient did well with potassium replacement. The patient was advised will have to do outpatient PET scan. Patient was found to have positive blood cultures as well 4/26/21 68 y.o. female who presents from nursing home with complaints of elevated white blood cell count. According to nursing home records patient had CBC checked on Saturday 04/24/2021 and her WBC count was found to be 50,000. At that point in time no other orders were given and patient was not sent in for evaluation. CBC was repeated this morning and WBC count found to be in the 70,000s. Patient was sent in for evaluation this morning. In talking with the patient, she denies any runny nose, sinus drainage or cough. Patient does report shortness of breath. Patient denies any chest pain or palpitations. Patient denies any dysuria, hematuria, fevers, or chills. Patient denies any nausea or vomiting. Patient does report diffuse pain across the lower abdomen. She does report chronic diarrhea. Patient had C diff stool checked on 04/13/2021 and was negative. (4/26 cdiff positive) Of note patient does have known lung mass that was seen on chest x-ray and PET scan. Patient reports that she does not want anything done and understands it could be cancer. And continuing to question patient, she reports she wants to be a DNR and does not want any aggressive measures.
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| 67 | 2021-04-27 | nausea |
She was 'bouncing off the walls'.; unsteadiness; Nausea; extreme dizziness; fatigue/bad enough that ...
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She was 'bouncing off the walls'.; unsteadiness; Nausea; extreme dizziness; fatigue/bad enough that for 3 days she couldn't work; This is spontaneous report received from Pfizer Sponsored Program Support from a contactable consumer (patient). This 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in upper left arm on 15Mar2021 09:30 (Lot Number: EN6207) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were none. The patient experienced nausea on 15Mar2021 18:00, extreme dizziness on 15Mar2021 18:00, fatigue/bad enough that for 3 days she couldn't work on 15Mar2021 18:00, she was 'bouncing off the walls' on an unspecified date, unsteadiness on an unspecified date. She went on 15Mar2021 to get her first shot and then she was went for her second vaccine this past Saturday. Patient stated they denied giving her the 2nd dose of the covid vaccine after hearing about her side effects form the 1st one. She would like to know whether she needs to get the 2nd dose. She had pretty bad reactions to the first shot. She got the shot around 09:30 in the morning and by 6 pm she felt the reactions. Patient reported the following side effects form the 1st dose of the covid vaccine: nausea, extreme dizziness and fatigue, bad enough that for 3 days she couldn't work. She was 'bouncing off the walls', unsteadiness and spent the next three days in bed due to fatigue. There was no event require a visit to emergency room and physician office. There was no prior vaccination (within 4 weeks) and no adverse event following prior vaccinations. The outcome of event nausea was recovered on 16Mar2021, extreme dizziness and fatigue/bad enough that for 3 days she couldn't work was recovered on 18Mar2021, She was 'bouncing off the walls' was recovered on an unspecified date, unsteadiness was unknown. No follow-up attempts are possible. No further information is expected.
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| 67 | 2021-04-27 | nausea |
Nausea; Dizzy; Face Hot; Trouble breathing/chest tightness; Trouble breathing/chest tightness; 1hr p...
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Nausea; Dizzy; Face Hot; Trouble breathing/chest tightness; Trouble breathing/chest tightness; 1hr pain to shot; administered in right leg; This is a spontaneous report received from a contactable hcp (patient). A 67-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in right leg on 15Mar2021 09:30 (Batch/Lot Number: EN6204) as single dose for COVID-19 immunization. Medical history included known allergy, asthma, atrial fibrillation, urticaria. Concomitant medications included cetirizine hydrochloride (ZYRTEC) as pre treated; diphenhydramine hydrochloride (BENADRYL) as pre treated. The patient previously received the first dose of BNT162B2 (Batch/Lot number: EN6200) on 20Feb2021 13:00 in left leg by injection for COVID-19 immunization. The patient experienced nausea, dizzy, face hot, trouble breathing/chest tightness, pain to shot, all on 15Mar2021. Clinical course: Pre treated u/ 50mg Benadryl and 1 Zyrtec. 1hr pain to shot. u/in 15 minutes of shot: Nausea, dizzy, face hot, trouble breathing/chest tightness, given oxygen +2 more Benadryl laid down u/ feet up, discharged 1200HR Sx resolved by next day (24hours). The outcome of the events was recovered on 16Mar2021. No follow-up attempts are needed. No further information is expected.; Sender's Comments: There is a reasonable possibility that the events nausea and vaccination site pain were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the events "face hot, trouble breathing/chest tightness" with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 67 | 2021-04-28 | nausea |
collapsed, head hit the tile floor of bathroom; collapsed, head hit the tile floor of bathroom; righ...
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collapsed, head hit the tile floor of bathroom; collapsed, head hit the tile floor of bathroom; right arm was bruised; corner of her eye was purple/bruised; feeling nauseated; Headaches off and on; pain; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6208) intramuscular, administered in Arm Left, at the age of 67-year-old, on 19Mar2021 11:00, as SINGLE DOSE for covid-19 immunisation. Medical history included asthma and Allergies. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6203) single dose, at the age of 67-year-old, on 26Feb2021, for covid-19 immunisation and experienced slight ache in her left arm, headaches, and mitral valve disease. On 20Mar2021, the patient had headaches off and on and the patient mostly woke up with them. The patient doesn't know if the headaches were from pollen in the air since it is Spring time or mold. On 24Mar2021 at 4am, the patient got out of bed because she had to use the restroom. As soon as the patient took the first step into the tile floor of the bathroom, the patient collapsed. The patient didn't fall, the patient collapsed on the file floor. Her head hit the floor. Her head was killing her when she was laying there. The patient used the restroom and went back to bed. The patient got out of bed because her head was killing her. The patient guesses she threw her right arm out to brace herself, because she noticed her right arm was bruised the morning of 24Mar2021 when she went to shower. The patient took Equate 500MG for the events head hit the tile floor of bathroom, headache, and right arm was bruised and used a wash cloth with cold water as a cold compress and applied it by her eyebrow, the corner of her eye was purple/bruised. It looked like she had eyeshadow on. On 24Mar2021, she was feeling nauseated. Thankfully, she had the next 2 days off (Thursday and Friday) because she didn't feel so hot. On 26Mar2021, the patient called her PCP and was asked if she wanted to come in/ make an appointment. Since, the caller was planning to meet with the surgeon about her upcoming surgery on 29Mar2021, it didn't really fit into her schedule. She was undergoing all these tests, etc. It was determined her surgery was going to happen after receiving the second vaccine. The surgery is hopefully a mitral valve repair. The patient mentioned that her provider is aware of her experience with the COVID vaccine. The patient saw the surgeon on 29Mar2021, and she told him all about her experience. He advised the patient to call her PCP and schedule an appointment with them. She saw her PCP on 01Apr2021. She told her PCP what happened and her PCP asked why she didn't go to urgent care. The patient doesn't really know why she didn't, she just thought she was going to feel better. The patient thought she would work through the pain since Mar2021. Plus, she had everything going on with her surgery- like finding out she had to have the surgery and going under other tests. Her PCP wanted her to go to radiology to have a MRI of the head/brain done. She had the MRI done at 3:00PM on 06Apr2021 and the results were negative. Up until last weekend, she still felt "headachy". The patient has headaches too because of stress knowing her surgery was scheduled in a matter of 2 weeks, so she didn't know if the headaches she was experiencing was because of the COVID vaccine, stress, allergies, etc. The patient was certain the headache she experienced the day after she collapsed, was due to the collapse. The patient clarified that she knew it was more of a "collapse" instead of a fall because all the furniture leading to the bathroom, like the loveseat, lamp, cedar chest, etc, were all intact with no marks. It was like all of a sudden she collapsed. Her bruising is all gone, but there might be a slight mark that is like yellow and green (because the bruising changes colors) on her arm. Her eye was okay. The patient will have her planned surgery on 15Apr2021. The events required physician office visit. The patient underwent unspecified lab test and procedures relevant to her upcoming surgery but no other testing in regards to her symptoms after the COVID vaccine. Outcome of headache was not recovered, the events corner of her eye was purple/bruised and right arm was bruised recovered in 2021, while it was unknown for the other events.
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| 67 | 2021-04-30 | vomiting, nausea, diarrhea |
bleeding/bruising; CP (Cerebral palsy); itchy /itchiness; shaky; hot; Chest tightness; Anxiety; misc...
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bleeding/bruising; CP (Cerebral palsy); itchy /itchiness; shaky; hot; Chest tightness; Anxiety; misc mental health; arm pain; bleeding/bruising; localized rash; SOB (Shortness of breath); NVD (Nausea, vomiting, and diarrhea); NVD (Nausea, vomiting, and diarrhea); NVD (Nausea, vomiting, and diarrhea); Visual/Neuro concerns; Visual/Neuro concerns; mechanical irritation; This is a spontaneous report from a non-contactable other HCP. A 67-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN6205) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. During her 15-minute waiting period after the injection, the patient began to experience itchy, shaky, hot, chest tightness. Patient monitored and improving. Patient ambulates well without dizziness. Chest tightness resolved and itchiness improving. Precautions discussed with patient. Patient aware of what to monitor and when to go to ED. Patient voiced understanding and appreciated. Patient able to ambulate out of the facility with ease. Vaccine-Related Anxiety (include misc mental health), Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) and Red flag symptoms (CP (Cerebral palsy), SOB (Shortness of breath), NVD (Nausea, vomiting, and diarrhea), Visual/Neuro concerns). Outcome of pruritus was recovering, chest discomfort was recovered on an unspecified date. Outcome of rest of the events was unknown No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. however, Relevant medical history and concurrent disease are missing for a medically meaningful assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 67 | 2021-05-06 | nausea, vomiting |
fainting; Severe head, neck and back pain; Severe head, neck and back pain; Severe head, neck and ba...
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fainting; Severe head, neck and back pain; Severe head, neck and back pain; Severe head, neck and back pain; nausea; vomiting; This is a spontaneous report from a contactable consumer, the patient. This 67-year-old non-pregnant female patient reported that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8737) via an unspecified route in the right arm on 19Apr2021 at 14:45 (at the age of 67-years-old) as a single dose for COVID-19 immunization. Medical history included chronic severe tension headaches and allergies to some antibiotics (unspecified products). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior to vaccination. Concomitant medications included unspecified supplements and herbals. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7534) on 27Mar2021 at 14:45 in the right arm as a single dose for COVID-19 immunization. On 20Apr2021 at 02:30, the patient experienced severe head, neck and back pain, combined with nausea, vomiting and fainting. There was no treatment received for severe head, neck and back pain, combined with nausea, vomiting and fainting. The clinical outcomes of severe head, neck and back pain, nausea, vomiting and fainting was recovering. The patient was not tested for COVID post vaccination.
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| 67 | 2021-05-07 | decreased appetite |
cardiac enzymes were extremely elevated; Weight from 223 pounds to 211 pounds in 2 months; No appeti...
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cardiac enzymes were extremely elevated; Weight from 223 pounds to 211 pounds in 2 months; No appetite; Sleep pattern is bad/she cannot fall asleep until 0400 and then wakes right back up around 0800; Feels rough with fine bumps at times; Feels rough with fine bumps at times; Itches at times; Rash on outer aspect of arm; Tightness, uneasiness in chest; Palpitations, Fluttering in Chest; Palpitations, Fluttering in Chest; Easily Winded; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose on 16Mar2021 (Batch/Lot Number: EN6207; Expiration Date: 31Jul2021), then the second dose on 07Apr2021 (Batch/Lot Number: ER8730; Expiration Date: 31Jul2021), both via an unspecified route of administration, at the age of 67-years-old, administered in arm left as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) from 2002 and ongoing, ongoing diabetes mellitus, penicillin allergy from an unknown date and unknown if ongoing, became really sick, really fast, uncertain if was Covid 19 from Feb2020 to an unknown date and chest discomfort from an unknown date and unknown if ongoing. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)), glyceryl trinitrate (NITROGLYCERIN), both taken for chest discomfort; dulaglutide (TRULICITY) taken for an unspecified indication, all from an unspecified start date and ongoing. The patient previously took morphine and codeine and experienced drug allergy. The patient was at her eye doctor on 02Apr2021 and decided afterwards to have her grandson take her to the Emergency Room (ER) for some tightening and uneasiness she had been having in her chest over the preceding days. She also felt some palpitations, they were fast, then slowed down; did not feel labored. She went to the ER and was there for 8 hours. They told her that her cardiac enzymes were extremely elevated. After the cardiologist reviewed her results she was allowed to go home. She went to her regular cardiologist on 05Apr2021. That cardiologist went over her tests results and said that while it was not normal results for her he didn't find them too worrisome. He stated that just because her enzymes are elevated does not mean she is in trouble. He scheduled her for a Dobutamine Stress Test on 07Apr2021. She has been trying to get the results of this stress test from the doctor's office but has not been successful in doing so. Says that once she completed the Stress Test on 07Apr2021 she went to get her second dose of the Covid Vaccine. She was still having her symptoms when she got her second vaccine and they have continued since. She saw her endocrinologist who went over blood work with her. The endocrinologist told her that her blood glucose level was very good and her A1c was a 5.5. The endocrinologist was concerned because usually the A1c is between 6 and 7. Patient was 5 foot 6- and one-half inches. Tightness, Uneasiness in chest: Stated it is not pain, just an uneasy, uncomfortable, fluttering feeling. Palpitations, Fluttering in chest: Not a labored feeling, goes fast, then slows down, not constant. Rash on outer aspect of arm: Extends from her wrist to about 2-3 inches below her elbow. Outside of arm, not on the inner part of her arm. Feels rough with fine bumps at times; then will feel smooth again. Itches at times. She uses calamine lotion, which does help to relieve the itching and smooth the skin. Stated it eventually does come back though. Easily Winded: She has had respiratory conditions all of her life. This winded feeling, she has been having is different than that she stated. She gets the fast heartbeat really quick, can almost hear it; becomes winded and sits down. The episodes last about 15 minutes. She has had no appetite; she has lost almost 15 pounds in 2 months. Her weight was 223 pounds 2 months ago and now weighs 211 pounds. She mentioned her sleep pattern is bad. Some days she cannot fall asleep until 0400 and then wakes right back up around 0800. The patient underwent lab tests and procedures which included blood glucose: 100 on 22Apr2021, blood pressure measurement: 128/62 on 21Apr2021, body temperature: 97 degrees fahrenheit on 21Apr2021, haemoglobin: 5.5 on Apr2021, heart rate: 78 on 21Apr2021, myocardial necrosis marker: extremely elevated on 02Apr2021, oxygen saturation: 98 % on 21Apr2021. Therapeutic measures were taken as a result of rash on outer aspect of arm, Feels rough with fine bumps at times and Itches at times. The outcome of the events Itches at times, Feels rough with fine bumps at times, Rash on outer aspect of arm, Easily Winded was not recovered; Palpitations, Fluttering in Chest and Tightness, uneasiness in chest was recovering, while of the rest was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between the suspect drug and the events cannot be excluded. This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 67 | 2021-05-13 | nausea |
blacking out; seeing gray splotches; nauseous; light headed; I barely made it back to bed; This is a...
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blacking out; seeing gray splotches; nauseous; light headed; I barely made it back to bed; This is a spontaneous report received from a contactable consumer (reporting on herself). A 67-years-old Non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EP6955 and Expiration Date was not reported), via an unspecified route of administration in Arm Left on 09Mar2021 10:15 as single dose for COVID-19 immunization. Medical history included hypertension, blood cholesterol increased, obesity , goitre , sciatica , arthritis, fibromyalgia, all from an unknown date and un-known if ongoing. Concomitant medication(s) included meloxicam (MELOXICAM); gabapentin (GABAPENTIN); levothyroxine (LEVOTHYROXINE); atorvastatin (ATORVASTATIN) all taken for an unspecified indication, start and stop date were not reported. The patient previously took ibuprofen, sulfa and synthroid and experienced drug hypersensitivity, First dose of BNT162B2 on 16Feb2021 09:15 for covid-19 immunisation The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that patient was up at 5:30 am and started seeing gray splotches and then she got nauseous and started blacking out. It happened again about 10 minutes later and she barely made it back to bed be-fore the whole thing stopped. When she woke up later she was still a little light headed. The out-come of the events was recovered on an unspecified date.
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| 68 | 2021-01-03 | diarrhea | Low Grade fever, Diarrhea |
| 68 | 2021-01-04 | nausea, vomiting |
headache; nausea; vomiting; chills, rigor; fever; fatigue; This is a spontaneous report from a conta...
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headache; nausea; vomiting; chills, rigor; fever; fatigue; This is a spontaneous report from a contactable other hcp. A 68-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), intramuscularly in the left arm on 24Dec2020 at 07:30 (at the age of 68-years-old) as a single dose for COVID-19 vaccination. Medical history included penicillin allergy from an unknown date and unknown if ongoing, latex allergy from an unknown date and unknown if ongoing and a thyroid disorder from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient previously took iodine for an unknown indication and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Dec2020 at 15:30, the patient experienced headache, nausea, vomiting, chills, rigor, fever and fatigue. No therapeutic measures were taken as a result of the events. The clinical outcome of the headache, nausea, vomiting, chills, rigor, fever and fatigue was not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 68 | 2021-01-07 | abdominal pain upper |
woke up with 100.5 fever, head ache, chills , generalized body aches, stomach ache, Called my work,...
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woke up with 100.5 fever, head ache, chills , generalized body aches, stomach ache, Called my work, they ordered, rapid Covid 19 test, waited for 3 hours and came back negative, but I'm having fever 100.3 for two nights and 99.0 at day time, with head ache and stomach ache,
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| 68 | 2021-01-07 | diarrhea, nausea |
1-2 minutes after injection: lip tingle, bi-lat side back of tongue, some neck discomfort, slight he...
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1-2 minutes after injection: lip tingle, bi-lat side back of tongue, some neck discomfort, slight headache, eyelid drop-bi-lat. Lasted 30 minutes. Day 2- symptoms returned approx 10:30 am - 3:00 pm. Nore intense included dizziness, shakes, overall malise, chest tightness. Later that day, mild diarrhea, mikd nausea. Day 3- woke with wheezing. Symptoms all continued for next 10 days off and on. The lip, tongue seemed to get shorter and shorter in duration. Also has mouth watering. Afternoon would bring on overall malaise issues. 2nd and 5th day, the worst. On 3 day went to urgent care, prednisone 40 mg x days, pepcid, zyrtec. Back to urge t care day 6, Ed day 8. Day 14 abd 15 awful chills, muscke ache and shaking.
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| 68 | 2021-01-07 | nausea, indigestion |
Extreme acid stomach. Can on the night of the vaccine and nausea the next day. I still have the stom...
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Extreme acid stomach. Can on the night of the vaccine and nausea the next day. I still have the stomach acid.
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| 68 | 2021-01-07 | nausea |
Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left...
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Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea.; Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea.; Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea.; Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea; Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea.; Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea.; This is a spontaneous report from a contactable consumer, the patient. A 68 -year-old elderly female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL0142), via an unspecified route of administration in the left arm on 29Dec2020 at 02:30 PM, (at the age of 68 -years-old) as a single dose, dose number=1 for COVID-19 vaccination. Medical history included hypothyroidism and osteopenia. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included levothyroxin and citalopram within 2 weeks of the vaccination. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 02Jan2021, the patient woke up with a red and swollen, slightly itchy, left 4th finger, redness progressed to left hand, and arm, generalized red rash noted in groin and abdomen, slight headache and nausea. The patient was treated for red and swollen, slightly itchy, left 4th finger, redness progressed to left hand, and arm, generalized red rash noted in groin and abdomen, slight headache and nausea with diphenhydramine (BENADRYL) 50 mg x 1. The clinical outcome of red and swollen, slightly itchy, left 4th finger, redness progressed to left hand, and arm, generalized red rash noted in groin and abdomen, slight headache and nausea was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 68 | 2021-01-09 | diarrhea, abdominal pain |
Pain at injection site (resolved within 48 hours). Chills, lightheadedness, warm (not feverish), ab...
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Pain at injection site (resolved within 48 hours). Chills, lightheadedness, warm (not feverish), abdominal cramping, loose stool x 5 over 48 hours. Extreme fatigue (over 5 days)
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| 68 | 2021-01-10 | nausea | Chills nausea body aches dizziness fever |
| 68 | 2021-01-11 | decreased appetite, nausea |
moderate, and intermittent nausea; lack of appetite; fatigue; malaise; sometimes chills; This is a s...
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moderate, and intermittent nausea; lack of appetite; fatigue; malaise; sometimes chills; This is a spontaneous report from a contactable nurse (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Dec2020 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. A couple of hours after she received the Pfizer-BioNTech Covid-19 Vaccine last 21Dec2020, she started to experience moderate, and intermittent nausea, lack of appetite, fatigue, malaise, and sometimes chills; all on 21Dec2020. She said that the worse of all side effects she's experiencing was nausea. HCP also said that she was still experiencing the side effects until now. She also mentioned that she got tested for Covid, and results came back negative. However, she said that she will get tested again just to make sure she did not have the virus. The events were reported as non-serious. The outcome of events was not resolved. Information on the Lot/Batch number has been requested.
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| 68 | 2021-01-11 | nausea, vomiting |
Sore arm Low grade fever between 101-102 F Really bad body aches Nausea and vomiting that lasted 24 ...
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Sore arm Low grade fever between 101-102 F Really bad body aches Nausea and vomiting that lasted 24 hours Fever has continued in the afternoons
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| 68 | 2021-01-12 | diarrhea, abdominal pain upper |
Itching of tongue, face, under arms & groin, headache, intense chills & shakes, fever 101.9, stom...
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Itching of tongue, face, under arms & groin, headache, intense chills & shakes, fever 101.9, stomach pain, diarrhea Still experiencing fever and diarrhea.
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| 68 | 2021-01-13 | abdominal pain upper, nausea |
Stomach (Abdominal pain); Nausea, headache, feverish, but no temp; minor Body aches. Began around 9:...
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Stomach (Abdominal pain); Nausea, headache, feverish, but no temp; minor Body aches. Began around 9:00 A.M. (2 hrs After injection). Nausea & other symtoms gone by A.M. 12-29-20.
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| 68 | 2021-01-13 | abdominal pain, nausea | Severe abdominal cramps moving up towards diaphragm. Complete exhaustion. Nausea |
| 68 | 2021-01-13 | diarrhea, nausea |
Ten minutes after the vaccine was administered, I began to taste it in the back of my mouth, a metal...
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Ten minutes after the vaccine was administered, I began to taste it in the back of my mouth, a metallic-type taste and felt tingling around my mouth. I had been sitting in the post-vaccine observation area during this time looking at my telephone. I approached the nurse's desk and reported what I was experiencing and was taken to another room where I was put in a wheelchair and vital signs were taken. By now I think I became very anxious and fearful and my heart felt like it was pounding at 104. My BP went to 188/79 which is high for me and I felt SOB. I truly think the VS symptoms were related to anxiety, but I continued to have the taste in my mouth and my tongue felt like sandpaper. I was given 50 mg BENADRYL and observed for 30 minutes. After that amount of time, I felt better and safe to leave the hospital. Today, 1/14/2021, I have felt excessive tiredness and mentally dazed with diarrhea. No temperature, slight nausea this morning, and no vomiting. My left arm is only moderately sore. Now, at 7:30 pm I am feeling better and feel that I can work tomorrow. Honestly do not know if it was an adverse reaction or excessive anxiety. I do not have anxiety disorder.
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| 68 | 2021-01-13 | indigestion |
Most concerning was dizziness to the point of almost fainting. This happened 2 times. Once on the fi...
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Most concerning was dizziness to the point of almost fainting. This happened 2 times. Once on the first day after injection and once on the second day after injection. Other S.C. were fatigue, muscle aches, chills, indigestion and sore arm. No fever noted.
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| 68 | 2021-01-16 | decreased appetite, abdominal discomfort |
chills, headache, body aches, spaced out feeling, loss of appetite, sick stomach, 100.5 fever for 2 ...
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chills, headache, body aches, spaced out feeling, loss of appetite, sick stomach, 100.5 fever for 2 days-this felt similar to how I felt when I had Covid 19 March-April.
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| 68 | 2021-01-17 | difficulty swallowing |
After 15 minutes felt light headed and throat started to constrict slightly. Had an Allegra with me...
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After 15 minutes felt light headed and throat started to constrict slightly. Had an Allegra with me, so took it. Seemed to subside in about 30 minutes. Took a benedryl at bedtime. In morning, seemed ok, though took another benedryl. Seemed OK on this next day, but before bed, face was puffy, then woke up at 3:50 a.m. Saturday, and throat glands swollen and was having difficulty swallowing.
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| 68 | 2021-01-17 | nausea, decreased appetite |
Migraine headache on waking days 1, 2 and 3. Joint pain, nausea, lack of appetite, dizziness on day ...
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Migraine headache on waking days 1, 2 and 3. Joint pain, nausea, lack of appetite, dizziness on day 2. Same symptoms to a lesser extent Day 3. Day 4 no symptoms.
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| 68 | 2021-01-17 | nausea, vomiting, diarrhea | severe headache soon after vaccination, vomiting, nausea and diarrhea also |
| 68 | 2021-01-18 | GERD |
severe pain in the middle of her chest that was acid reflux/bad GERD; This is a spontaneous report f...
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severe pain in the middle of her chest that was acid reflux/bad GERD; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EJ1686, expiry date: 31Mar2021), intramuscular in the left arm on 04Jan2021 11:00 (also reported as 12:00) at a single dose for COVID-19 immunisation. The patient's medical history included Gastrooesophageal reflux disease (GERD) which she has not had this since she was pregnant 36 years ago. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The caller stated she had the COVID vaccine on Monday (04Jan2021) at 11:00am. Later that day at 6:00pm she had severe pain in the middle of her chest that was acid reflux/bad GERD. She has not had this since she was pregnant 36 years ago. She stated that the sharp pain in her chest was really really bad, she thought she was having a heart attack. She stated the pain went away, but she has really bad acid. The caller asked if this is this normal? Additionally, how long do side effects in general last? She wanted to go lay down because her stomach was hurting. The outcome of the event was not recovered.
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| 68 | 2021-01-18 | nausea |
Started with uncontrollable chills that lasted 1 hr , Fever. The next day ( saturday)tiredness , h...
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Started with uncontrollable chills that lasted 1 hr , Fever. The next day ( saturday)tiredness , headache joint pains , muscle pains , chest pains and nausea as well as Fatigue . I started taking Tylenol 500mg po q 6 hrs and that improve the sxs. The site of the injection was extremely red and swollen as well as lymphadenopathy underneath the left arm ( site of injection). The next day ( sunday) I noticed a swelling underneath the axilla going on top of the bra with blood exudate and looked as if I had bumped an object. The weakness continued during the next week and slowly the tiredness got better ( TOOK AT LEAST 7-10 DAYS).
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| 68 | 2021-01-19 | blood in stool, vomiting |
1/15 - HAD SLIGHT HEADACHE AND BODY ACHES IN LATE EVENING AND CHILLS AND TEMP 100.1 AT 10PM. 1/16- ...
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1/15 - HAD SLIGHT HEADACHE AND BODY ACHES IN LATE EVENING AND CHILLS AND TEMP 100.1 AT 10PM. 1/16- 6AM HEADACHE; 10AM TEMP 100.2 WITH BODY ACHES AND VERY TIRED; 12 NOON VOMITED; 3PM TEMP 101.2. BODY ACHES, TIRED AND CHILLS. HAD SMALL AMT OF BLOOD IN STOOL (STOPPED ADVIL); 5PM TEMP 100.1 1/17 - 10AM TEMP 99; 11AM TEMP 98 AND REMAINED AFEBRILE WITH HEADACHE. 1/15 2:40PM- ADVIL 200MG+TYLENOL 500MG; 9:30PM 400MG ADVIL 1/16 6AM ADVID 400MG; 3PM TYLENOL 500MG 2 TABS 1/17 7AM TYLENOL 500MG 2 TABS
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| 68 | 2021-01-20 | nausea |
3:18 sitting in general observation and c/o left side arm pain, radiating up neck. Describes pain as...
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3:18 sitting in general observation and c/o left side arm pain, radiating up neck. Describes pain as throbbing 5/10. Also c/o nausea. O2 97% on room air, HR 86; EMT on site in attendance. 3:24 BP 206/118 on Lt upper arm taken per EMT 3:30 BP 182/118; HR 118 per radial pulse. States pain now 2/10 is is a dull pain to a burning warm sensation. 3:35 O2 98% r/a, HR 68 3:40 BP 132/80 HR 66, O2 97% r/a. Patient states she is feeling better. Patient decided to go home accompanied by husband to private vehicle. EMT recommended to patient the she f/u with doctor is she feels worse. Ambulated with husband.
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| 68 | 2021-01-20 | nausea | Nausea, joint pain, fever, chills, fatigue. 2 days duration |
| 68 | 2021-01-21 | abdominal discomfort |
Felt shaky, started to have facial swelling and tongue swelling and had to take diphenhydramine. St...
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Felt shaky, started to have facial swelling and tongue swelling and had to take diphenhydramine. Started to feel abdominal and chest tightness. Taken to ER and given IV diphenhydramine and IV dexamethasone
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| 68 | 2021-01-21 | nausea |
Chills, fever to 100.7, mild nausea, malaise, fatigue all resolving in 24 hours. A transient light r...
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Chills, fever to 100.7, mild nausea, malaise, fatigue all resolving in 24 hours. A transient light rash (hives) noted at bedtime 48 hours after injection, totally resolving by morning. Not sure this were real adverse advents,but very happy to have had a robust reaction indicating it's working! !!
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| 68 | 2021-01-21 | nausea |
I immediately sat down for 1 hour, felt I had something , like i felt possible slight chest tightnes...
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I immediately sat down for 1 hour, felt I had something , like i felt possible slight chest tightness. I say I was fine until 3-4 hours later, I had extreme headaches. At 430pm, I still had the headaches and I took Tylenol 500mg. At night my headache got worse and it felt like I had the flu. I then went to bed and when I woke up my left arm felt intense like hornets and it was swollen. I then took another Tylenol and Ibuprofen 600mg. At 4am, I felt awful and horrible. I had joint pain with aches, felt nauseated. I called my PCP and he told me to take Prednisone 10mg. My fever was 101.4F. By the night my fever was gradually coming down and it was 102F. By the next day I felt much better. I also had Covid-19 on March 2020 and also got tested for antibody test in July 2020. I spoke with my PCP and he is recommending I do not take the 2nd dose injection.
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| 68 | 2021-01-24 | diarrhea, decreased appetite | chills,diarrhea,body,aches,no appetize |
| 68 | 2021-01-25 | diarrhea, decreased appetite | No appetite. Diarrhea fatigue Lasted 7 days.Then normal. |
| 68 | 2021-01-25 | nausea |
Mild headache within 1 hour of vaccine. Fatigue in evening necessitating early to bed. Slept thro...
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Mild headache within 1 hour of vaccine. Fatigue in evening necessitating early to bed. Slept through the night and awake in am without symptoms. Getting out of bed sudden drop in BP with weakness, feeling faint, nausea, sweating. Drop in BP to 68/52. Unable to go to work. Improved with upright resting in am with BP at 10:30 am 119/69 (low as my usual BP averages 130's/mid 80's). Still slightly nauseous. Able to have toast and tea. Felt better as am progressed and able to drive to work at 11:45 am. Worked until 6 pm without further symptoms.
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| 68 | 2021-01-25 | nausea |
About 12 hours after injection I developed a fever, body aches, chills, and severe arm soreness, hur...
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About 12 hours after injection I developed a fever, body aches, chills, and severe arm soreness, hurt to lift my arm. Also had some slight nausea and headache. Took Ibuprofen helped some. Next day still felt off, arm still extremely sore, body aches, headache, fatigue. I continued with the Ibuprofen alternating with Tylenol. Finally felt better by Sunday and was able to return to work on Monday.
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| 68 | 2021-01-25 | retching, diarrhea |
Patient self-reported through the hospital. In her own words, "After 2nd dose of Pfizer COVID-19 Vac...
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Patient self-reported through the hospital. In her own words, "After 2nd dose of Pfizer COVID-19 Vaccine 1/15/21 @ 0630, at 2030 developed generalized aching, chills, weakness and sleepiness. Woke up at 0300, went to bathroom and passed out returning to bed. Awakened soaked in perspiration. Had dry heaves and 1 loose stool. Felt weak and sleepy until 0700, then felt mostly normal. Symptoms relieved by 1000. No other symptoms after that".
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| 68 | 2021-01-26 | indigestion | Burning sensation in upper stomach, chest, throat. Rapid heartbeat |
| 68 | 2021-01-26 | nausea |
immediate dizziness and elevated heart rate after vaccine, and somewhat elevated blood pressure afte...
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immediate dizziness and elevated heart rate after vaccine, and somewhat elevated blood pressure after an hour felt better, went home to bed with fatigue, slight nausea and headache
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| 68 | 2021-01-26 | nausea |
6 days after vaccine I had fever, nausea, headache, stiff neck, fatigue. Symptoms lasted 2 days and...
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6 days after vaccine I had fever, nausea, headache, stiff neck, fatigue. Symptoms lasted 2 days and are improving.
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| 68 | 2021-01-26 | nausea |
.On the way home after receiving vaccine, began to have feeling of facial flushing and swelling. No ...
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.On the way home after receiving vaccine, began to have feeling of facial flushing and swelling. No outward sign. Symptoms continued throughout the rest of the day. Mild headache, some nausea. No difficulty breathing, no fever, no hives or rash. General uneasy feeling. Next morning awoke with "fullness "in ears, with some ringing. Facial symptoms would come and go. On Sunday, two days after vaccine, I felt much better, facial symptoms better, ears still felt plugged. Could ear fine. On Monday , symptoms pretty much gone. I was in contact with primary physician through email/phone message. No treatment was necessary.
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| 68 | 2021-01-27 | decreased appetite, nausea |
Back pain; tired; whole body trembled; nervous; facial tingling; immediate pain in arm from injectio...
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Back pain; tired; whole body trembled; nervous; facial tingling; immediate pain in arm from injection; couldn't lift her arm at all; left eye twitching; Chills; Nausea; no appetite; whole body ache; This is a spontaneous report from a contactable consumer reporting for herself. A 68-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 11Jan2021 5:15 PM at a single dose on arm for COVID-19 immunization. Medical history included ongoing shellfish allergy from 1975 (she carries epi pen), ongoing iodine allergy from 1975 (she carries epi pen), ongoing Mitral valve prolapse (for 20 years), blood pressure high, and cholesterol. The patient had mitral valve prolapse for about 20 years now. They are just watching it now. She just saw the cardiologist, and had an echo done. If the symptoms worsen, they will proceed. Concomitant medications included diltiazem for blood pressure high and atorvastatin for cholesterol, both from an unspecified date and ongoing; she has been on these medications for 30 years now. On 11Jan2021, the patient experienced facial tingling, immediate pain in arm from injection, couldn't lift her arm at all, left eye twitching, chills, nausea, no appetite, whole body ache, tired, whole body trembled, nervous. On 12Jan2021, the patient experienced back pain. The patient explained that on 11Jan2021, evening at 5:15pm, she received her first COVID 19 vaccine. The Pfizer vaccine was being given out at that time. She has shellfish and iodine allergies. So, they made her sit and wait 30 minutes after being injected. One of her daughters took her. On the drive home, a few minutes after leaving she developed facial tingling. At first, she thought nothing of it. She did have immediate pain in her arm from the injection. By the time she got home, she couldn't lift her arm at all. It was that painful. The next morning, she couldn't lift arm, and if she tried, she would be in pain. Also, her left eye started twitching right away also. That night she really noticed it. It was not a constant twitching. She thought at first it was because she was tired or from the pain in her body. But then she noticed the next day it was still doing that. It was still twitching. It is not constant, but it was here and there. She still had it on 13Jan2021, but so far nothing at the day of report (14Jan2021). She also had chills. She had on double clothes, and coverings on her feet and hands. The chills wouldn't go away. Her whole body trembled. On 13Jan2021, Wednesday morning, they went away. She experienced nausea and no appetite. Her whole body ached. It was so brutal. The problem was with her left eye. It didn't twitch constantly, but it got her nervous. She is pretty sure she is going to refuse the second dose. She has heard that the 2nd part is when most people have the worst side effects. So, she is not comfortable getting it. She also got back pain. It wasn't severe, but it was there. She is against getting the second shot. She stated that she is a medical assistant at a pediatric office. She doesn't have a prescribing doctor. She got it (vaccine) because of her age. She was advised to get it as she was around patients. Work gave them the option. The inability to move her arm ended in the middle of night at 4 am 14Jan 2021. She noticed she could move her arm. Her second dose is scheduled for 01Feb2021 at 8:45 am. She does work in a pediatric office. If the second part of side effects are worse, then she doesn't want to take the chance. The eye has her concerned. Outcome of the events were as follows: facial tingling recovered on 11Jan2021, immediate pain in arm from injection recovered on 13Jan2021, chills recovered on 13Jan2021, nausea recovered on 13Jan2021, no appetite recovered on 13Jan2021, whole body ache recovered on 13Jan2021, couldn't lift her arm at all recovered on 14Jan2021, back pain was recovering, while outcome for events left eye twitching, tired, whole body trembled, and nervous, was unknown. Information about lot/batch number has been requested.
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| 68 | 2021-01-27 | diarrhea, nausea | Debilitating headache, nausea, chills, aches, pains, light-headed, disorientation, diarrhea, more |
| 68 | 2021-01-27 | nausea, vomiting |
Patient presented to the ED on 1/21/21 for evaluation of SOB stating her husband tested positive for...
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Patient presented to the ED on 1/21/21 for evaluation of SOB stating her husband tested positive for COVID earlier that week and she has been around him. The patient states her symptoms started 3-4 days prior to presentation. She admits to cough, nausea, and an episode of vomiting the day of presentation. She had been intermittently using her husband's oxygen prior to presentation which she says has helped with her symptoms, but does not use oxygen at baseline. Upon presentation the patient's oxygen saturation rate on room air is 89%. Patient was placed on 2L oxygen via nasal cannula and then was saturating in the mid 90s. CXR demonstrated bilateral patchy infiltrates in the ED which the ED physician felt to be consistent with COVID infection. The patient's rapid COVID test resulted as positive. The patient was admitted to the hospital for further management of hypoxia related to COVID infection. The patient remains hospitalized on the day of report submission (1/28/21)
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| 68 | 2021-01-28 | abdominal pain upper | Shakes, tongue and lip sweeping, pain in stomach and headache |
| 68 | 2021-01-28 | nausea, vomiting | shore arm, fever chills body aches nausea and vomiting |
| 68 | 2021-01-28 | nausea |
tiredness; headache; muscle aches; nausea; dizziness; This is a spontaneous report from a contactabl...
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tiredness; headache; muscle aches; nausea; dizziness; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL1283), via an unspecified route of administration on 11Jan2021 at 11:00 AM at a single dose on the left arm for COVID-19 immunization. Medical history included Barret's esophagus and glaucoma both from an unknown date and unknown if ongoing. Concomitant medication included dorzolamide;timolol maleate (manufacturer unknown) and pantoprazole (manufacturer unknown). The patient did not have COVID-19 prior to vaccination. The patient did not have other vaccines in four weeks. The patient previously took codeine and experienced allergies. The patient experienced tiredness, headache, muscle aches, nausea and dizziness all on 12Jan2021 at 03:30 PM. The patient did not receive any treatment for the events. The outcome of the events was recovered. No follow-up attempts are possible. No further information is expected.
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| 68 | 2021-01-30 | nausea | Headaches Nausea Dizziness Aches |
| 68 | 2021-01-31 | diarrhea |
Had a floater in Left eye for 4/5 days, started last week for a few. Diarrhea several times sinc...
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Had a floater in Left eye for 4/5 days, started last week for a few. Diarrhea several times since the shot (no big deal although more than normal). This last one is the one I'm concerned about believe I have a UTI infection for the last 5 days, self treating with many products. It's getting a little better ... just concerned. Wondering if I should get an antibody test before the second shot ..... HELP!
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| 68 | 2021-01-31 | vomiting |
Dizzy; throwing up; This is a spontaneous report from a contactable consumer. A 68-year-old female p...
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Dizzy; throwing up; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3249), via an unspecified route of administration on left arm at 13:00 on 15Jan2021 at single dose for COVID-19 immunization. Medical history included diabetes, blood pressure abnormal and blood cholesterol abnormal. Concomitant medication included amlodipine taking for two or three years for blood pressure, atorvastatin taking for a year for cholesterol, canagliflozin (INVOKANA) taking for two years for diabetes, losartan taking for two or three years for blood pressure, metformin taking for two years for diabetes and pioglitazone taking for two years, all ongoing. Last night on 17Jan2021, the patient was throwing up and felt dizzy. She still felt that a little today. She was planning to get the second dose 05Feb2021. The outcome of events was not recovered.
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| 68 | 2021-02-01 | nausea, diarrhea |
101.2 fever, chills, body aches, nausea, diarrhea, very sore left arm. Symptoms started early morni...
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101.2 fever, chills, body aches, nausea, diarrhea, very sore left arm. Symptoms started early morning of 01/29/2021 and lasted until midday on 01/30/2021.
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| 68 | 2021-02-02 | nausea, diarrhea, abdominal pain upper, blood in stool |
1.23~starting with stomach ache and lots of elimination which turned into diarrhea. 1.24~awful diarr...
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1.23~starting with stomach ache and lots of elimination which turned into diarrhea. 1.24~awful diarrhea and stool was black for a few eliminations. Fever, Chills, Nausea, arm sore, headache, fatigue, body ache 1.25 ~ symptoms continued 1.26 ~ more black stool. Dr. advised me to go to ER. They did find blood in stool. 2.1~finally had normal bm and started to feel better
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| 68 | 2021-02-03 | nausea, decreased appetite |
Jan. 29 (evening): mild headache, mild chills, pain at injection site Jan. 30 (all day): moderate he...
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Jan. 29 (evening): mild headache, mild chills, pain at injection site Jan. 30 (all day): moderate headache, chills, aching (muscles), fatigue, low-grade fever (100.2), mild nausea, sore upper arm Jan. 31: mild headache, mild muscle/joint ache, chills, fatigue, pain at injection site, loss of appetite Feb. 1: mild pain at injection site Feb. 2: all symptoms resolved
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| 68 | 2021-02-03 | nausea |
2nd dose COVID-19 vaccine (Pfizer EK4176) received on Thursday 1/28/21. approxx 8 hours later devel...
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2nd dose COVID-19 vaccine (Pfizer EK4176) received on Thursday 1/28/21. approxx 8 hours later developed headache which increased in intensity and eventually triggered a migraine, severe dizziness making it impossible to sit/stand, muscle aches,nausea. no temperature or chills. The headache lasted all day lasted all day Friday and decreased in intensity by Saturday. With rest, the dizziness resolved by Friday evening. The muscle aches remained mildly for a few days.
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| 68 | 2021-02-04 | abdominal pain upper, diarrhea, nausea |
The night of the vaccine she woke up with: Diarrhea, black stools, weakness, fever, chills, stomach ...
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The night of the vaccine she woke up with: Diarrhea, black stools, weakness, fever, chills, stomach ache, nausea, rash on abdomen
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| 68 | 2021-02-04 | decreased appetite, diarrhea |
6 hrs after injection swelling began and headache (About 9PM). Next morning swelling from shoulder t...
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6 hrs after injection swelling began and headache (About 9PM). Next morning swelling from shoulder to elbow & headache, chills, tool Tylenol. No appetite, very loose bowels at 10:00 am, (NOTE: NO fever) headache, chills continued all day & dizziness was added only when I moved my eyes like to glance at something or trying to read . Woke up, all symptoms were gone except a little swelling around injection site. 48 hours after injection, only very little swelling at injection site.
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| 68 | 2021-02-04 | gastrointestinal pain | Intestinal pain, chills, generally feeling unwell |
| 68 | 2021-02-05 | nausea |
Lightheaded initially. Felt a little nauseous and tired Then went home and experienced vertigo when...
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Lightheaded initially. Felt a little nauseous and tired Then went home and experienced vertigo when I turned my head or bent forward. Still having vertigo off and on since vaccine. I have had vertigo before but usually never lasts this long or has felt quite like this.
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| 68 | 2021-02-05 | nausea |
Early morning after vaccine started with headache then nausea and chilling. Chilling all day and ev...
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Early morning after vaccine started with headache then nausea and chilling. Chilling all day and evening Fever must have broke about 24 hours or so after with breaking out in a sweat. Symptoms just keep getting worse as the day progressed . Almost 24 hours after the bones just hurt. Today, 2/6/21, two days after vaccination still have nagging headache
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| 68 | 2021-02-06 | nausea | Headache. site of Injection. slight nausea. Flu like feeling. |
| 68 | 2021-02-06 | vomiting, diarrhea, decreased appetite |
Beginning about 12 hours after injection, for apporximately 36 hours after injection, I had a fever ...
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Beginning about 12 hours after injection, for apporximately 36 hours after injection, I had a fever (high of 101), chills, pounding headache, body aches, vomiting, diarrea. I felt incredibly tired and slept, restlessly, on and off for 24 hours. I was unable to even drink anything for about the first 15 hours. Finally I was able to eat two crackers and tea and take tylenol which took the edge off the headache. All of these sympoms persisted for 36 hours. It was miserable and I honestly have never felt so sick. That is coming from someone who has been through labor, childbirth, c- sections, and several major surgeries. I don't think I could do another vaccine without being supervised in a health care facility to help manage the side effects for the first few days. Also, I had a mild case of Covid beginning November 9, 2020 that lasted about 2 weeks. I was only exposed to one person who had covid that I am aware of. When I was with that person for about 15 minutes, we were masked and 6 feet apart. I do not go anywhere but work and am always masked, as is everone else I work with and we are always at least 6 feet apart.
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| 68 | 2021-02-07 | difficulty swallowing |
Felt week and clammy, reported trouble swallowing then numbness in face; rapid response called, tran...
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Felt week and clammy, reported trouble swallowing then numbness in face; rapid response called, transferred to ED. 1:43: HR: 74, RR: 16, O2: 97%, BP: 112/66 END Other daily meds: Protonix, Simbicort, Eliquis(Unable to type on 2nd page)
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| 68 | 2021-02-07 | nausea |
blood shot right eye; Allergic reaction; Chills; Her lips are a pinkish color as if she is still hav...
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blood shot right eye; Allergic reaction; Chills; Her lips are a pinkish color as if she is still having some type of reaction; She did have nausea this morning; This is a spontaneous report from a contactable consumer reporting for herself. A 68-years-old female patient received bnt162b2 (BNT162B2; Lot # EL1283) , via an unspecified route of administration on 21Jan2021 at single dose for Covid-19 immunisation . Medical history included cataract operation on 10Nov2020, oedema , swelling , brain operation on 2016 , aneurysm (aneurysm that did not rupture and there are 8 coils protecting that) , implantable cardiac monitor insertion , hypertension. Concomitant medication included lisinopril dihydrate (LISINOPRI)Lacetylsalicylic acid (ASPIRIN BAYER), amlodipine besilate (AMLODIPIN) pravastatin sodium (PRAVASTATIN) The patient experienced chills on 21Jan2021 with outcome of not recovered , her lips are a pinkish color as if she is still having some type of reaction on 21Jan2021 with outcome of not recovered , she did have nausea this morning on Jan2021 with outcome of unknown , blood shot right eye on 22Jan2021 with outcome of not recovered , she thinks she had an allergic reaction on 21Jan2021 with outcome of not recovered. The patient received Benadryl, Prednisolone and Ketorolac as treatment. Follow up information has ben requested.
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| 68 | 2021-02-08 | nausea |
Pt c/o felt nausea, sweaty, ears became tingling and then went number. Was in placed in a wheelchair...
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Pt c/o felt nausea, sweaty, ears became tingling and then went number. Was in placed in a wheelchair and assisted to private location. C/o eyes feeling funny and tearing. next c/o chest pressure and tingling started down legs. Breathing labored and flushed skin. Epi administered and assisted to ER.
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| 68 | 2021-02-08 | nausea | CHILLS, FEVER UP TO 101 DEGREES, BODY ACHES, NAUSEA, WEAKNESS LASTED FOR 24 HRS THEN WEAKNESS |
| 68 | 2021-02-09 | abdominal pain upper, nausea |
Nasty taste in mouth , Headache, started 25 min. after shot. Nausea and stomach pain started at 10 P...
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Nasty taste in mouth , Headache, started 25 min. after shot. Nausea and stomach pain started at 10 PMon the 6 Feb. 2021. body aches. On 7th the same. Nausea went away on 8th. arm sore. went away on 9th. the nasty taste still have it on 10th. No headche stopped on 9th. Just feel week. going away on 9th of Feb.
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| 68 | 2021-02-10 | abdominal pain upper | Uncontrollable shaking chills, fever, headache stomach pain |
| 68 | 2021-02-11 | retching, nausea, vomiting |
I was fine except for soreness in the arm and a mild headache from the time I got the vaccine (Wedn...
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I was fine except for soreness in the arm and a mild headache from the time I got the vaccine (Wednesday 1:20 p.m.) through the evening, but woke up (Thursday morning about 6:00) very sick . I had a worse headache, extreme tiredness, nausea , vomiting (dry heaves as I couldn?t eat or drink the whole time), fever and chills. The bouts of vomiting fever and chills came in three through the day. I felt extremely unwell the whole time and just kept reminding myself that it would be over soon, but it lasted throughout Thursday. I fell asleep around 5:00 p..m. Thursday afternoon and woke up around midnight feeling that the symptoms had passed. Now it?s Friday morning (5:30 a.m.) and I feel completely well again.
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| 68 | 2021-02-16 | abdominal pain upper, diarrhea |
Within 24 hours of receiving vaccine, client experienced severe diarrhea-watery yellow stools x5 and...
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Within 24 hours of receiving vaccine, client experienced severe diarrhea-watery yellow stools x5 and stomach cramping.
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| 68 | 2021-02-16 | difficulty swallowing |
out like a 'light' and this stuff knock her out; whole entire face her head, down her back her neck ...
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out like a 'light' and this stuff knock her out; whole entire face her head, down her back her neck was numb/Numbness in leg/jaws are numb; I'm feeling my teeth are still and my jaws are numb; felt very odd sensation as she was swallowing; was closing up but much wasn't closing up/it was not full open; swelling on her throat; Muscle pain in my left arm where they gave me injection and it hurts my neck area across my back down my arms specially my left side; it hurts my neck area across my back; it hurts my neck area across my back; Stumbling; face was swollen; eyes looks like little switch; thirsty; felt very sluggish; nose started to running; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first single dose BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (anatomical location: arm left) on 29Jan2021 15:00 for COVID-19 immunization. Medical history included insomnia and asthma. The patient's concomitant medications were not reported. Patient stated, "I got the vaccine yesterday about 3 pm and I came home and I had dinner and sat down to watch TV at 9 O' clock, I turn the program on and I was out like a 'light' and this stuff knock me out (onset date: 29Jan2021). My dog has to wake me up licking my face at 3:15 this morning. I normally don't sleep long 4 hours and that's it. I'm 68 years old and I have insomnia (History) but when I woke up I was stumbling around, still have to sleep (onset date Jan2021), I took the dog out to walk and came back and saw myself in mirror, my face was swollen and my eyes looks like little switch. I noticed, I was thirsty and I went to get and drank, some coke because I felt very sluggish and I drank some coke and when I was swallowing the coke I felt very odd sensation as I was swallowing, I noticed that after swallowing. I have asthma (History) to begin with so I'm anticipated on having some of the symptoms it start showing up a bit, my nose started to running and I noticed that my whole entire face my head, down my back my neck was numb along with swelling on my throat, I felt okay but I felt it wasn't being, it was closing up but much wasn't closing up you know what I mean it was not full open. I also had muscle pain in my left arm where they gave me injection and it hurts my neck area across my back down my arms specially my left side. I also noticed I went to a lovely person and when I went to bathroom I pull my pants down I felt numbness on my legs. So, my whole body was kind of having that not tingling sensation but numb and when I ran my fingers across my leg you know how you feel numbness when you run your fingers across a part of your body when it's numb that's exactly how I felt and that was about 3:30 this morning that happened I woke up by but I also want to ask question because I got to go back to my second shot. I'm wondering if I go back to my second dose am I going to have even more intense reaction to the stuff that I get this time." Patient further added "I was still trying to eat something but I'm feeling my teeth are still and my jaws are numb and this I got since yesterday (29Jan2021)." The outcome of events was unknown. Information on the lot/batch number has been requested.
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| 68 | 2021-02-17 | diarrhea, abdominal discomfort |
Joint pain; had liquid diarrhea; Stomach not crampy but urgency when it happens; Medical history inc...
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Joint pain; had liquid diarrhea; Stomach not crampy but urgency when it happens; Medical history include coeliac disease; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL9262; expiration date: unknown), via an unspecified route of administration right arm on 23Jan2021 11:00 at a single dose for covid-19 immunization. Medical history included essential tremor, coeliac disease, high blood pressure, and allergies to wheat and dairy. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included enalapril (ENALAPRIL), venlafaxine hydrochloride (EFFEXOR), propranolol and hydrochlorothiazide (HCT). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported for about a week, she has had liquid diarrhea. The patient also has joint pain, stomach not crampy but urgency when it happens and no fever. The patient did not received treatment for the adverse events and the event was non-serious. The patient has not been tested for COVID-19 since the vaccination. The onset of the events was on 26Jan2021 and the outcome of the events was not recovered.
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| 68 | 2021-02-18 | nausea, decreased appetite |
I had a serious case of COVID-19 in 3/2020. After the vaccine, I felt like I had the illness all ov...
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I had a serious case of COVID-19 in 3/2020. After the vaccine, I felt like I had the illness all over again. I got a fever of 101, loss of appetite, slept 16 hours a day, headache, slight nausea, some pain at injection site. This lasted about 48 hours. I took two Tylenol 20 hours after the vaccine as the headache was so bad. I got better within 48 hours. No medical help was sought.
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| 68 | 2021-02-18 | vomiting, nausea |
Severe migraine headache associated with visual distortion, nausea/vomiting, and prolonged word-find...
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Severe migraine headache associated with visual distortion, nausea/vomiting, and prolonged word-finding difficulty lasting at least a few days. No prior history of migraines. TIA work up ongoing.
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| 68 | 2021-02-21 | difficulty swallowing |
Chest pains by heart once in the car; Itching by neck, shoulders, upper arms, legs, back; Throat clo...
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Chest pains by heart once in the car; Itching by neck, shoulders, upper arms, legs, back; Throat closed up a bit; Sore upper left arm at injection site; Headache; Fatigue; Later on sharp pains in left calf upon walking; Numbness in left facial cheek and left side of tongue; Numbness in left facial cheek and left side of tongue; Difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265, expiry date not reported), via an unspecified route of administration in the left arm on 02Feb2021 13:30 at single dose for COVID-19 immunization. Medical history included allergies or hypersensitivity. Concomitant medication was not reported. The patient was not pregnant at the time of vaccination. The patient was vaccinated at a health facilty. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received second dose of varicella zoster vaccine (lot number and expiry date not reported) on 18Jan2021 at single dose for immunization. Five minutes after first shot of Pfizer Covid 19 vaccine, on 02Feb2021 13:35, it began itching by neck, shoulders, upper arms, legs, back; throat closed up a bit. The patient was administered 50 mg Benadryl, but itching continued. The patient had sore upper left arm at injection sight. They waited at the vaccination facility under care of 3 nurses for one hour. The patient was offered Epi-pen, but did not administer Epi-pen. The patient's husband drove her home. She had chest pains by heart once in the car. The patient had headache, fatigue, and later on sharp pains in left calf upon walking, numbness in left facial cheek and left side of tongue and difficulty swallowing. Clinical outcome of the events was not recovered.
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| 68 | 2021-02-22 | nausea |
I got the shot at 10:30am. My arm was mildly painful at the injection sight. During the next early ...
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I got the shot at 10:30am. My arm was mildly painful at the injection sight. During the next early morning (~2:00am Friday, Feb 19) I had the chills for about 2 hours. I had intermittent muscle pain, nausea, and fatigue. These symptoms resolved during the day Friday, February 19th.
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| 68 | 2021-02-23 | diarrhea | Diarrhea beginning today (2/23). No other symptoms, denies bloody stool or abdominal pain. |
| 68 | 2021-02-23 | diarrhea | Diarrhea for two days and some weakness from the diarrhea |
| 68 | 2021-02-23 | nausea | Body aches, chills, tired, nausea, started next morning, lasted a day and a half. |
| 68 | 2021-02-24 | diarrhea, abdominal pain, nausea |
Pt received her first Pfizer COVID vaccine today at approximately 1305. She stated approximately 10...
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Pt received her first Pfizer COVID vaccine today at approximately 1305. She stated approximately 10 minutes into observation she developed abdominal pain and felt like she needed to have a BM. She sat on the toilet and had an episode of diarrhea and started to feel flushed, diaphoretic and stood up to go to the sink. She then felt nausea, dizziness and lightheaded and placed her head down leaning over the sink. EMT arrived to bathroom and sat patient down in a wheelchair. I arrived on scene shortly thereafter and the patient was pale and diaphoretic stating she did not feel well. EMS was activated. She was placed on the cardiac monitor and her HR was NSR in the 80's. BP 114/61, 96% on RA. Denied CP, SOB, rash, mouth, lip or tongue swelling. She was brought back to the observation area and was assisted to the gurney. Cool compresses were placed on her forehead and behind her neck. Medics arrived to scene to assess the patient. She stated she was feeling improved and did not want to go to the ED. She signed the AMA form. She was given water and crackers. She was monitored for 1 hour and stated she felt improved. She denied dizziness, lightheadedness, nausea or abdominal pain. I assisted her to the bathroom and she had one more episode of diarrhea. She stated she felt improved after that. She was monitored for 15 more minutes and stated she would like to go home. She was able to get up off the gurney without assistance, stated she felt well. She was ambulatory with a Steady gait and assisted outside. Prior to discharge I recommended she follow up with her PCP. Advised that she rest for the remainder of the day and to activate 911 should she develop any new or worsening symptoms. Advised that if she does get the second dose of vaccine she should be laying down at the time of administration and for 30 minutes after the injection for observation.
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| 68 | 2021-02-24 | nausea | After 4 hours from injection had nausea and very rapid heartbeat. Went away after 2 hours |
| 68 | 2021-02-24 | nausea |
After first shot on 1/28/21: Very slight headache next two mornings and very slight arm at site of s...
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After first shot on 1/28/21: Very slight headache next two mornings and very slight arm at site of shot. After second shot on 2/20/21: Almost imperceptible arm soreness day after (when driving and arm touched driver door), slight nausea (extremely unusual for me) on afternoons of 2/21, 2/22 & 2/23 along with moderate afternoon fatigue those days (I napped which is extremely unusual for me). Alka Seltzer didn't help but CupOSoup eliminated the nausea completely.
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| 68 | 2021-02-25 | nausea, diarrhea |
a little tenderness on the injection site; diarrhea; nausea; This is a spontaneous report from a con...
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a little tenderness on the injection site; diarrhea; nausea; This is a spontaneous report from a contactable consumer. This 68-year-old female consumer reported for herself that she received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9261) at single dose on 24Jan2021 at 13:00 for COVID-19 immunisation. Relevant history included thyroid removal on 11Sep2019, and tumor removed from her appendix on May2020. Relevant family medical history was none. Concomitant Products included: Levothyroxinesince Sep2019 and Ongoing. FIBO tests in 2020 that were positive for Hydrogen FIBO. The patient experienced no symptoms by then except for a little tenderness on the injection site. On 26Jan2021, she experienced a sudden onset of diarrhea and nausea at 15:00. Treatment included Zofran. The patient stated that she did get the Vsafe contact but not today (26Jan2021). Outcome of event nausea was not resolved, outcome of other events was unknown. No emergency room required, no physician office visit. No any other vaccinations within four weeks prior to the first administration date of the suspect vaccine.
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| 68 | 2021-02-25 | nausea |
high fever, swollen face, rash in face, headache, nausea, swollen lymph nodes, joint pain, chills, w...
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high fever, swollen face, rash in face, headache, nausea, swollen lymph nodes, joint pain, chills, weakness, overall feeling not well.
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| 68 | 2021-02-26 | vomiting, nausea |
Pfizer-BioNTech COVID- 19 Vaccine EUA Approx 5 minute post vaccination, patient began reporting itch...
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Pfizer-BioNTech COVID- 19 Vaccine EUA Approx 5 minute post vaccination, patient began reporting itching. Shortly after, developed a dry cough and reported that her throat "felt funny." Patient began vomiting and having difficulty breathing, speaking in 1-2 word sentences. Pt received epi pen to left thigh, with some resolution of symptoms. Pt continued to have cough and nausea, chest pain. Gave 25 mg benadryl IM at 08:27 am. Patient received 2nd dose of Epi for increased SOB, difficulty breathing, and increasing cough, with some resolution of symptoms. Patient reported increased chest pressure. Began having seizure like activity at 08:30, lasting approx 20 seconds with no post ictal period noted. EMS arrived after 2nd dose of epi. Second "seizure like" activity after EMS arrival, lasting approx 20 seconds. During transport to ambulance, patient had 2 more episodes of seizure like activity with no post ictal phase. ED note states low suspicion for true seizure since patient was awake during episodes of tonic clonic movements, answering questions during, and did not have post ictal state.
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| 68 | 2021-02-27 | decreased appetite |
First shot only chills and mild muscle aches gone by the next morning. Second shot aftereffects wer...
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First shot only chills and mild muscle aches gone by the next morning. Second shot aftereffects were very different. Received the shot around noon on Tuesday , February 23, 2021. Later in the afternoon experienced muscle aches and chills. My head felt kind of weird. Hard to describe except I once had a morphine shot that made me feel close. I spent the next ~60 hours in bed. Fever, severe joint and muscle pain, migraine like headache, and brain fog is about all I remember. It could have been 2 hours or 60 hours, I don't remember. On Wednesday and Thursday my sedentary heart rate was 101 and 95 according to my Apple watch up from 77 on Tuesday. Couldn?t eat. Food tasted and smelled differently but not in a good way. Woke up this morning,Friday, with a mild headache and very fatigued but mostly back to normal.
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| 68 | 2021-02-27 | diarrhea, decreased appetite |
Night sweats, chills horrible muscle bone aches diahrrea, no appetite, had to crawl to the bathroom ...
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Night sweats, chills horrible muscle bone aches diahrrea, no appetite, had to crawl to the bathroom the last 3 days on hands and knees. Lethargic . Tired. Fatigue. 4 days now. And I am getting worse. Heaviness on chest
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| 68 | 2021-02-27 | nausea, decreased appetite, vomiting |
Next day could not stand up without vomiting, fever 101, progressively worse as day went on to the p...
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Next day could not stand up without vomiting, fever 101, progressively worse as day went on to the point I could not lift my head off pillow. Could not eat, even sips of water or coke. Hard to breathe Day 2 fever 100 and slept most of day, still nauseous and dizzy with no appetite. Hard to breathe. Day 3 slept 12 hours and normal is 7 hours. Able to eat clear broth and drink lots of water. Fever 99.9 but went down to just 99. Normal for me is 96 and sometimes 96. Hard to breathe. Day 4 Teeth look off color. Able to eat egg, but no sense of taste. Sleep almost back to normal, but no energy. Sudden movement or bending I get out of breath.
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| 68 | 2021-02-27 | nausea |
Several hours after injection my arm hurt down to almost the elbow. Not bad. Next day same until a...
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Several hours after injection my arm hurt down to almost the elbow. Not bad. Next day same until about 3:30 and I started to get chills, body aches and pains then nausea and headache. Shivering for 4-5 hours under the covers in bed with extra blankets and clothes. Can?t say I?m overly concerned as searching online I?ve seen reports of similar reactions but best to report. Today feeling a bit better, not shivering but still achy but not as bad and still a little nauseous.
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| 68 | 2021-02-28 | nausea, abdominal pain upper |
Bad headache, chills, fever, nausea, redness at injection site, stomach ache, weakness. The injecti...
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Bad headache, chills, fever, nausea, redness at injection site, stomach ache, weakness. The injection was on Friday and Saturday we woke up with the side effects. Sunday we were much better and Monday better.
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| 68 | 2021-02-28 | nausea, vomiting, diarrhea | Chills, dizziness, nausea, vomiting, diarrhea, fatigue |
| 68 | 2021-03-01 | decreased appetite |
The inside of my lips swelled up and there was tingling sensation. My tongue started to swell up and...
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The inside of my lips swelled up and there was tingling sensation. My tongue started to swell up and there were little bumps along the edges of my tongue. My throat was okay, and I didn't have any other reactions. I had an EpiPen with me, but I didn't need to use it. It began to gradually subside after four hours, and it last for eight hours. I had a decreased appetite.
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| 68 | 2021-03-01 | nausea | Extreme fatigue, sudden of onset. Mild nausea. |
| 68 | 2021-03-02 | abdominal pain, nausea, vomiting |
severe stomach flu like symptoms; protracted vomiting; nausea; abdominal cramping; muscle aches; inj...
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severe stomach flu like symptoms; protracted vomiting; nausea; abdominal cramping; muscle aches; injection site reaction; This is a spontaneous report from a contactable other hcp (patient). This 68-year-old female patient (pregnant no) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number En6200), via an unspecified route of administration on 20Feb2021 10:30 AM on left arm at single dose for COVID-19 immunization. Medical history included high blood pressure. Concomitant medication included rosuvastatin and hydrochlorothiazide/losartan. The patient experienced injection site reaction and severe stomach flu like symptoms, nausea, protracted vomiting, abdominal cramping and muscle aches on 20Feb2021 19:00. The patient had not received other vaccine in four weeks. There was no treatment received, no COVID prior vaccination and no COVID tested post vaccination, no known allergies. The outcome of the events was recovering.; Sender's Comments: Drug causality for suspect drug BNT162B2 in the onset of the reported events cannot be excluded . The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
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| 68 | 2021-03-02 | diarrhea, decreased appetite |
I got fever, I got diarrhea. I got body ache, headache.; I got fever, I got diarrhea. I got body ach...
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I got fever, I got diarrhea. I got body ache, headache.; I got fever, I got diarrhea. I got body ache, headache.; I got fever, I got diarrhea. I got body ache, headache.; I got fever, I got diarrhea. I got body ache, headache.; Unable to eat, loss of appetite.; Not feeling too well; very sick; can hardly move; This is a spontaneous report from a contactable consumer (patient). This 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL9069), via an unspecified route of administration at single dose on 10Feb2021 for covid-19 immunisation. Medical history included diabetes, thyroid removed. Concomitant medication included influenza vaccine, metformin, levothyroxine, ferrous sulfate, atorvastatin. The patient stated that experienced: I got fever, I got diarrhea. I got body ache, headache, unable to eat, loss of appetite, not feeling too well, very sick, can hardly move , all on an unspecified date in Feb2021 with outcome of unknown. The patient was hospitalized for these events from Feb2021 to an unknown date. The patient underwent lab tests and procedures which included investigation: unknown results in Feb2021.
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| 68 | 2021-03-02 | nausea, indigestion |
Burning of the eyes, and stomach, along with nausea. BP's 142/46 (pulse 64), 155/60. Given juice and...
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Burning of the eyes, and stomach, along with nausea. BP's 142/46 (pulse 64), 155/60. Given juice and crackers.
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| 68 | 2021-03-02 | nausea |
Soreness in injected arm, chills, dizziness, headache, muscle pain, joint pain, nausea, general mala...
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Soreness in injected arm, chills, dizziness, headache, muscle pain, joint pain, nausea, general malaise, lasting almost 2 days
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| 68 | 2021-03-02 | nausea | Fever, headache, body aches, nausea, chills |
| 68 | 2021-03-03 | vomiting, nausea |
she is having confusion and dementia,; went into this kind of like dementia-like state where she tal...
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she is having confusion and dementia,; went into this kind of like dementia-like state where she talked incessantly/ she is having confusion and dementia,; She had days of vomiting and nausea; She had days of vomiting and nausea; She complained of brain fog and couldn't focus on the tv or her programs; kidney functions were not good enough; she has mood swings; she could not remember or know everything from the present; she had a UTI; This is a spontaneous report from a contactable consumer (patient's sister). A 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular injection on 20Jan2021 (at the age of 68-year-old) at single dose for COVID-19 immunisation. Medical history included ongoing breast cancer stage IV, patient was in treatment for breast cancer stage IV, she had cancer 13 years prior the report in 2008, and then was found again and diagnosed 3 years prior the report, in Jun2018; chronic obstructive pulmonary disease (COPD), a long time, a lot of her adult life. The patient was on oxygen; she had a lot of fluid built up from the cancer; patient tested positive for COVID in 2020 (Feb2020 or Mar2020, as reported). She and her roommate tested positive and had a cough. They had no fever or other symptoms. Both in the nursing home got over the cough and 21 days later tested negative. Patient tested negative for COVID ever since. The nursing home tested the residents and staff every week. They had tested the patient so much to the point her nose was bloody which the reporter got upset about; hallucinations and paranoid thoughts. Concomitant medications included ongoing perphenazine (TRILAFON) taken for hallucinations and paranoid thoughts; treatment for breast cancer stage IV and oxygen. The patient lived in nursing facility and had received both Pfizer vaccine doses. The patient received the first vaccine for COVID-19 immunisation in Dec2020. She was fine. She got the second one on 20Jan2021. Since patient received the 2nd vaccine dose, in Jan2021, she was having confusion and dementia, which was not an issue before the vaccine doses. The patient was having trouble putting words together. Patient initially had vomiting, nausea and brain fog where she could not concentrate on her TV, in Jan2021. She was hospitalized from 17Feb2021 to 20Feb2021 to have all kinds of tests run and see if her cancer had spread to her brain. Patient had 3 years with stage 4 breast cancer and had fought so hard and was aware of her confusion and it was very upsetting to her. She had days of vomiting and nausea. She complained of brain fog and could not focus on the tv or her programs. Within days, she went into this kind of like dementia-like state where she talked incessantly and could not get a thought completed. Patient would go from one thought to the next. It was very bizarre. She had never had this kind of issues. This went on for so long, they finally put her in the hospital. Patient had stage 4 breast cancer, and the doctors thought maybe her cancer had gone to her brain. The doctor did not think it was related to the COVID-19 vaccine. She was checked for a urinary tract infection (UTI), for brain cancer, for a stoke, for everything. She saw so many doctors. She still had not come out of this a month later. She was currently on psych meds because she had mood swings, since Jan2021. It had been one thing after another. The patient could not tell the time. On some level, patient knew something was wrong. She was in a very confused state. She did not know how to tell anyone what she wanted to tell. It was very distressing to say the least. She had made a little bit of progress. She could tell time with some struggling but she got upset and cried. Patient could only tell that the time was 3, but not 3:15. But, then she cried and got upset. She had been able to tell time a couple of times, but if you asked her what day was it, she had no clue. She had no clue what day it was and would ask "what day is it?" Her moods all over the place. The patient was still very confused. The reporter explained the patient could be 5'3'', she was unsure. The reporter really did not know the patient weight, she was guessing around 270lbs. She had a lot of fluid built up from the cancer, and reporter had not seen her since COVID started. Patient told that her weight was up around 300lbs. The reporter declined to include a healthcare professional for the report, stating she had not spoken to her sister's primary care doctor. She was waiting for her to call back. The patient was sent to the ER and admitted into the hospital on 17Feb2021. She came back from the hospital on 20Feb2021 at 6:30pm. She had a CAT scan, MRI, bloodwork done, in Feb2021. She saw a psychiatrist, neurologist, her oncologist. There was so many doctors seeing her and talking to the reporter. The last doctor the patient saw in the hospital said that she thought the patient was dehydrated from her vomiting episodes, but did not know for sure. In Feb2021, the nursing home did blood tests and a urinalysis to see if she had a UTI. The blood work would have shown if patient was dehydrated and she was not. The head nurse thought it was the vaccine, but she was not sure. Everybody was not sure. No one could tell her anything concrete about patient. She was not normally like this. Patient had recovered completely from the nausea and vomiting. They tried for a while to give her an anti-nausea medicine, but she could not keep anything down. It was given to her orally, she did not know why an injection was not given. This lasted for a few days, clarified as maybe 3 days. The reporter had no name, NDC, lot number or expiry date for the anti-nausea medicine the patient took. She knew it was given to her once and when they tried to give it to her again, patient refused. Reporter had no product information to provide for the first and second doses of the COVID-19 vaccine, did not have the patient vaccine record card. This would be with the nursing facility. She mentioned patient went into the nursing home on Jan2018 and then was diagnosed with breast cancer Jun2018. She did not know if there were any interactions there with the patient having the breast cancer and receiving the COVID-19 vaccine. The reporter had no product information for the first dose. When probed for the date in which the first dose was given, she explained she was sent constant emails which could have provided a date, but she did not know this information offhand. It was approximately a month before the second dose, or it could have been on 27Dec2020, which was a little closer than a month apart. No additional vaccines were administered on the same date of the Pfizer vaccine. The events required a visit to emergency room. Patient had constant testing while in the hospital. In the hospital, in Feb2021, they did MRI and CAT scan to see if the breast cancer had gone to the brain and both were negative. They tested for UTI. They did the first UTI test at nursing home in 2021 and they said she had a UTI and patient was put on an antibiotic. They tested her again for a UTI when she was admitted into the hospital in Feb2021 and they said she did not have a UTI. She did have a buildup of urine in her bladder because her kidney functions were not good enough for the MRI at first, in Feb2021. Her bladder was relieved of the urine build up and her kidney functions improved and she was able to get the MRI. The MRI did not show any cancer in the brain. None of it relieved her symptoms. This was just bizarre. It happened within a week of receiving the vaccine. She could not talk with patient and patient had never been like that. The patient had always been lucid and open and you could talk about anything: the past, the present, she had no problems. She could remember everything crystal clear from the past but she could not remember or know everything from the present. The reporter would ask her what day was it and the patient did not know. The patient would absorb the information she was told but there was like this strange disconnect, almost like a dementia of some form. About concomitant medications, the reporter explained the patient had not started anything new. She had been on the same stuff for many years. She had psych meds that she had been on, but she had been on those for many years. She clarified further that patient had been stable on her psych meds for many years, and the nursing facility had the patient stable for 3 years at the nursing home. At the time of the report, her mood swings were all over the place, she had never had that before. She had hallucinations and paranoid thoughts in the past, but she had never had mood swings like this and never had dementia. She had been on the same medications for a long time, but they were currently trying to play with them and trying to adjust her psych meds. It was apparent it was not working and this was something more organic, something going on in her body. The psych med was perphenazine all of her life. The psych nurse was a new nurse and was not familiar with the patient. The psych nurse informed the reporter she raised the perphenazine to the highest dose she could possible go on and told she could have to try the patient on a mood stabilizer and could have to put her in a psych unit. The reporter would not have any NDC, lot numbers or expiration dates, or anything like that. The reporter had been told an UTI could have caused the patient symptoms. It could have been brain cancer, or this or that. She did not know what was going on. Reporter asked if there had been any reports or had other people called in with these types of reactions or adverse events. The patient had recovered from vomiting and nausea on an unknown date in 2021, had recovered from kidney functions were not good enough and UTI in Feb2021, the outcome of the other events was unknown. Information on the lot/batch number has been requested.
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| 68 | 2021-03-04 | nausea |
Woke up feeling quite clammy as if I had been sweating. Our bedroom is rather cold. Also felt nauseo...
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Woke up feeling quite clammy as if I had been sweating. Our bedroom is rather cold. Also felt nauseous. Didn't last long. Wiped my face and upper body with washcloth soaked in cool water for relief. Messaged my cardiologist and internist but haven't gotten response yet.
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| 68 | 2021-03-05 | diarrhea |
Bad chest pain, hard to take a deep breath, headache, dizziness, diarrhea. By the end of the day, be...
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Bad chest pain, hard to take a deep breath, headache, dizziness, diarrhea. By the end of the day, because of chest pain and dizziness my doctor sent me to the ER. I was then referred to a cardiologist, who indicated he thinks these symptoms are from the second dose of vaccine. He has seen several patients with the same symptoms after the second vaccine dose. My family doctor now thinks the same thing for the same reasons.
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| 68 | 2021-03-05 | nausea |
About 12 hours after 3/4 vaccine, began to experience intense flare-up of neuropathic pain in droppe...
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About 12 hours after 3/4 vaccine, began to experience intense flare-up of neuropathic pain in dropped R foot, especially around large R toe. Went to bed. Woke up in pain around 3 am on 3/5. Drank water. Applied Castor oil and Arnica. No sound sleep rest of night. On rising, showered. Heat helped a bit. Drank more water. Applied more Castor oil and Arnica. Pulsing electrical/spasm-like pain continued in R foot, especially between big toe and 2nd toe. Though felt vaguely nauseous, ate and stayed hydrated. Could not work. Laying down and warming, elevating foot helped. Around 9 pm on 3/5, intense flare-up began to subside.
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| 68 | 2021-03-05 | nausea |
Lightheaded, nausea, headache, eyes dry with itchiness and pain; joint and muscle discomfort; low gr...
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Lightheaded, nausea, headache, eyes dry with itchiness and pain; joint and muscle discomfort; low grade temp, fatigue, hair and scalp hurt. Symptoms lasted about 36 to 48 hours.
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| 68 | 2021-03-05 | nausea |
rash on lower back within an hour after vaccine. It disappeared soon. At 2:00 am on March 4th - wo...
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rash on lower back within an hour after vaccine. It disappeared soon. At 2:00 am on March 4th - woke with severe headache, musle and joint pain, chills, nausea, genarlly feeling unwell.
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| 68 | 2021-03-06 | nausea, decreased appetite |
Tightness in chest, chills, sore throat, fatigue extreme, headache, bodyaches and joints, blurry eye...
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Tightness in chest, chills, sore throat, fatigue extreme, headache, bodyaches and joints, blurry eyes, nausea, no appetite.
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| 68 | 2021-03-06 | vomiting |
About 11 hours after receiving vaccine vomited repeatedly, had chills and then short periods of feel...
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About 11 hours after receiving vaccine vomited repeatedly, had chills and then short periods of feeling very warm. Taste was off- many foods just did not taste good. General body aches, ambulation unsteady, blood sugar went up to over 700. This lasted until about 11 the next morning.
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| 68 | 2021-03-07 | diarrhea |
Diarrhea - lasting c. 8 hours No unusual foods were eaten, the effect cleared up completely within 2...
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Diarrhea - lasting c. 8 hours No unusual foods were eaten, the effect cleared up completely within 24 hrs. I?m attributing it to the vaccine (without complaint), but it is a guess. So grateful for the opportunity to receive the vaccine.
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| 68 | 2021-03-07 | nausea |
Patient developed swelling and redness in the face, tightness in the chest, and nausea in the stomac...
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Patient developed swelling and redness in the face, tightness in the chest, and nausea in the stomach.
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| 68 | 2021-03-07 | nausea |
Vile scary nauseating metallic taste in my mouth, still Here a week later! Fever and chills were n...
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Vile scary nauseating metallic taste in my mouth, still Here a week later! Fever and chills were no match for this awful taste I felt like I was poisoned!
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| 68 | 2021-03-07 | nausea | Dizzy, chills, nausea - came on suddenly (7 days after shot) and lasted about 4 hours. |
| 68 | 2021-03-07 | retching, nausea |
Pt received 1st dose of Pfizer Covid vaccine 3/5/2021 at the Health Dept at approx 9:35AM; pfizer lo...
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Pt received 1st dose of Pfizer Covid vaccine 3/5/2021 at the Health Dept at approx 9:35AM; pfizer lot number EL9269. Patient has hx of widespread rash from Penicillin; no history of anaphylaxis. Pt alerted the medic at 10:05AM that she was experiencing nausea and body weakness. No other symptoms noted at that time. BP 138/76 P84 O2RA 98%. At 10:35AM pt experiencing worsening nausea, body weakness, generalized prickle sensation, sudden left-sided headache, & dry heaving. Epi 0.3mg auto injector(Lot 0FM534) administered right leg 10:40AM; BP 178/104 P90. Paramedics called 10:42, arrived at 10:46AM and assumed care of patient. Patient transported to Hospital.
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| 68 | 2021-03-08 | diarrhea | Diarrhea every day starting day after second dose |
| 68 | 2021-03-08 | nausea | Severe body aches, fever, chills, severe headache 3 days now, nausea, exhaustion |
| 68 | 2021-03-08 | vomiting |
Client reports being "very sick" the next day with vomiting and headache. She has a history of havi...
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Client reports being "very sick" the next day with vomiting and headache. She has a history of having COVID 19 on 12/25/2020.
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| 68 | 2021-03-09 | diarrhea |
11 hrs after shot I had a very bad case of diarrhea. A day later my left arm muscle was very sore (...
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11 hrs after shot I had a very bad case of diarrhea. A day later my left arm muscle was very sore (not the injection site, the whole upper arm muscle). Three weeks after the shot, my arm is still very sore and I can hardly use my left arm. It's very painful to get dressed, take off a jacket, shirt, etc. I can hardly use the left arm to hold anything due to the pain in the muscle.
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| 68 | 2021-03-09 | difficulty swallowing |
2nd Pyzer Shot 2/8/2021 2:54 PM I believe I had an allergic reaction the first night: Arm twitched s...
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2nd Pyzer Shot 2/8/2021 2:54 PM I believe I had an allergic reaction the first night: Arm twitched several times approx. 6-7pm,Light headache approx. 8pm Anxiety increased between 8pm-2am,Woke 3:49 am with bad headache in rear of head, went to bathroom and turned over. Woke up with bad headache a little while later, Several times woke up struggling to swallow. Last time I woke up with Difficulty breathing and pressure on chest Decided I needed to wake my husband, but that is my last thought or action until I woke up 9AM. I take a generic Zyrtec at supper time each night. I think had I not had Zyrtec these symptoms could have been serious. Was OK until 3 – 11pm 3/9/2021 Slight headache & Shortness of breath.
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| 68 | 2021-03-09 | gastrointestinal disorder |
Gastrointestinal issues; Had occasional zaps of pain in toes and tiredness; Had occasional zaps of p...
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Gastrointestinal issues; Had occasional zaps of pain in toes and tiredness; Had occasional zaps of pain in toes and tiredness; This is a spontaneous report from a contactable consumer (patient). This 68-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EN5318) via an unspecified route of administration on 02Feb2021 at 16:00 (at the age of 68-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included pancreatic cancer. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included levothyroxine; pancreatin (CREON); famotidine; latanaprost; and calcium carbonate, vitamin b12, vitamin D (CALCE) from unknown dates for unspecified indications. The patient did not have any known allergies. On 03Feb2021 at 18:00 around dinner time, the patient started with gastrointestinal issues and also had occasional "zaps" of pain in toes and tiredness. These lasted into Saturday night (06Feb2021). The patient did not receive any treatment for the events. The outcome of gastrointestinal issues, zaps of pain in toes, and tiredness was recovering. It was also reported that the patient had not been tested for COVID-19 after the vaccination. No follow-up attempts are needed. No further information is expected.
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| 68 | 2021-03-09 | nausea, abdominal pain |
At 8pm began having headaches. At 10pm lost taste and smell, started experiencing body aches, abdomi...
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At 8pm began having headaches. At 10pm lost taste and smell, started experiencing body aches, abdominal pain and nausea for 3 days. Took Tylenol for pain and Famotidine and Pepto Bismol for nausea. As of 3/1/21 all symptoms relieved except for smell and taste.
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| 68 | 2021-03-10 | nausea, abdominal discomfort, vomiting, decreased appetite |
late evening of injections date, felt sick at stomach. early nxxt morning started vomiting thick ...
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late evening of injections date, felt sick at stomach. early nxxt morning started vomiting thick yellow bile. felt nausiated all day, "foggy" headache and lack of appetite. night sweats for 2 nights. no fever.
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| 68 | 2021-03-10 | vomiting |
Three days after dose 1 I experienced dizziness and violent vomiting (for 8 hours). Taken to emergen...
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Three days after dose 1 I experienced dizziness and violent vomiting (for 8 hours). Taken to emergency room. Admitted to hospital for hospital for 1 day. Was given anti-vomiting/dizziness drugs, CT scan, IV for dehydration, pain and anxiety medicine. Diagnosis was vertigo. Upon release from hospital, consult with internist further diagnosed condition as labarynthitis. Headache and slight dizziness continued for a couple of weeks . After second dose dizziness, light-headedness and headache are significant enough to take Tylenol regularly. These effects are still in place 12 days after 2nd dose. Will see internist if symptoms continue after 2 weeks.
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| 68 | 2021-03-11 | diarrhea, nausea | Severe headache, chills and slight nausea and severe diarrhea (causing me to lose 2 lbs.). |
| 68 | 2021-03-11 | diarrhea |
Diarrhea (usually 4+ times per day) began on 2/20/2021, and continues to today (3/12/2021). Fainte...
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Diarrhea (usually 4+ times per day) began on 2/20/2021, and continues to today (3/12/2021). Fainted 2/26/2021. To Urgent Care and then ER 2/27/2021. Suspected dehydration.
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| 68 | 2021-03-11 | nausea, vomiting |
Injection Friday 2/16, Saturday 2/27 afternoon, common symptoms, fever, chills, muscle aches. Sunday...
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Injection Friday 2/16, Saturday 2/27 afternoon, common symptoms, fever, chills, muscle aches. Sunday 2/28 through Monday Tuesday 3/2 nausea; Wednesday 3/3 vomiting, Thursday 3/4 nausea, Friday 3/5 nausea, Saturday vomited 2 times went to emergency room, Sunday 3/7 - Wednesday 3/10 nausea, Thursday vomiting, still nauseous.
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| 68 | 2021-03-11 | nausea |
Patient received vaccine at local health department clinic on 2/18 and started experiencing itching ...
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Patient received vaccine at local health department clinic on 2/18 and started experiencing itching and a rash during the monitoring period. Also complained of nausea. Patient has h/o autoimmune disorder and rosacea. Took 50mg diphenhydramine prior to arrival in this reporters facility ED. patient states very anxious about receiving vaccine. symptoms resolving discharged home from ED
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| 68 | 2021-03-12 | nausea |
34 after my 2nd vaccination I had severe palpitations. Knocked me out of bed. Lasted for hours. Ha...
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34 after my 2nd vaccination I had severe palpitations. Knocked me out of bed. Lasted for hours. Have had palpitations and sequela since, including elevated BP, some shortness of breath, nausea.
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| 68 | 2021-03-12 | nausea |
Started with very sore arm evening of shot. Next day - queasy stomach, headache, all over achiness,...
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Started with very sore arm evening of shot. Next day - queasy stomach, headache, all over achiness, continued sore arm but better than prior pm. Arm still a little sore following day but all other symptoms gone.
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| 68 | 2021-03-12 | vomiting, nausea |
Headache, aches within 8 hours. Within 20 hours developed severe vertigo and nausea. Movement caused...
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Headache, aches within 8 hours. Within 20 hours developed severe vertigo and nausea. Movement caused room spinning and broke out in cold sweat. Severe vertigo continued through second day (Feb 22), but seemed to diminish somewhat toward evening. Day 3 still had moderate vertigo/nausea but better than previous day. Went on a long walk. Day 4 moderate vertigo/nausea continued. Tried doing Epley exercises for vertigo. Vertigo/nausea became severe again, so severe I vomited several times. After vomiting got the shakes and felt very cold. Checked blood pressure and it was very high (170/98), but pulse rate was in low 30s. After a few hours blood pressure and pulse rate became closer to normal. Almost decided to go to ER clinic, but decided to wait until my daughter came home from work because I was way too dizzy to drive. After I calmed down I decided it wasn't an emergency. Severe vertigo continued through evening of day 4. On day 4 I called primary care doctor to see if there was anything I could do for the vertigo. She prescribed meclizine, but hearing that it is an antihistamine, I declined it (antihistamines make my heart race and make me very anxious). Severe vertigo/nausea continued through day 5 and day 6. (Severe vertigo/nausea being that I could not move around at all other than to sit still staring forward without the room spinning.) All this period I also had a headache, a feeling of pressure through my whole head/sinus area, and my vision was blurred. I also felt as though I could not focus my eyes or concentration. I tried using some over-the-counter nasal decongestant spray for 2 days to relieve congestion in head, but they made me feel very anxious, so I stopped. I also tried taking some Aleve a couple of times. It helped a little, but made me feel woozy, so stopped. Day 6 the vertigo/nausea improved to moderate, but I could still not walk straight. I felt unsafe to drive. Day 7 continued to improve, but still moderate vertigo/nausea. Day 8 I noticed a lot of improvement in vertigo/nausea. Kept improving day 9. By evening on day 10 I was noticing a rawness and lump in the back of my throat. Called primary care office day 11 to see someone. Drove car, but felt marginally safe driving. Was diagnosed with a sinus infection and prescribed a 10 day course of Amoxicillin/Clavulanic Acid (875-125 mg for 2 pills a day for 10 days). Felt improvement in throat and sinus over next few days. Day 15 I felt greatly improved with head ?fog? and vertigo. Had an appointment with an ENT clinic on day 15 to see what was causing vertigo. All tests were good for hearing, and visual examination of ears. Was checked for BPV but that was ruled out. Said vertigo was probably caused by viral infection or inflammation of vestibular nerve or canals. Recommended waiting for improvement and coming back if it persisted. Began doing more normal activities even though I still had mild vertigo. Day 16 felt still better in morning, then in afternoon bent over quickly to catch something and got a terrible wave of spinning again. Moderate/severe vertigo continued that evening. Improved to moderate on day 17 and 18. All along, when vertigo was worse, so was the ?fog? (blurry vision, inability to focus mentally). At day 19 I feel like I did on day 15, but I have noticed the pressure/lump around my ear and on left side of head is improved. Brain ?fog? is improved too, very mild and the vertigo is mild. I finish my antibiotic tomorrow.At present vertigo is not gone. Its mild today, but this is only one of maybe 2 1/2 days in which its been this mild (out of almost three weeks since I was vaccinated). I have been drinking a lot of water every day, and ginger tea when I get nauseous. I had my 2nd dose of the COVID Pfizer vaccine scheduled for Mar 15. I?ve cancelled it and intend to wait to see how long it takes for vertigo to finally resolve before considering a 2nd dose.
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| 68 | 2021-03-13 | decreased appetite, abdominal discomfort |
My stomach had been hurting since I received this shot. I am unable to eat because it makes my stom...
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My stomach had been hurting since I received this shot. I am unable to eat because it makes my stomach hurt worse.
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| 68 | 2021-03-15 | nausea, vomiting |
68 yo WF in excellent health with prior history of intermittent benign positional vertigo for seven ...
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68 yo WF in excellent health with prior history of intermittent benign positional vertigo for seven years and a cerebral concussion two years ago from which she recovered uneventfully in 6 weeks with no residual neurologic or physical issues. Patient received first dose 1/19/2021 with only mild fatigue and arm soreness at injection site. 16 hours after the second dose, Patient developed a dull total cranial headache and fatigue , retiring to bed , taking no medicines. She had taken only her premarin 0.625 mg for the last week. Patient awoke at 4:30 am with severe headache, nausea and vertigo, being unable to stand without assistance. urinary incontinence also occurred, but most likely occurred as she was unable to to get to the bathroom due to vertigo and pronounced vomiting of clear yellow fluid. incontinence never occurred again throughout the illness. examination at this time showed nystagmus on bilateral lateral gaze and vertical nystagmus. no other neurological signs or symptoms were present. On return to bed, Patient continued to have vertigo headache and nausea even supine with eyes closed. Vetigo and standing instability did not respond to epley manuvers. Headache remained mild to moderate, along with persistent vertigo and nystagmus for 4 days, becoming slightly less each day. On the fifth day, Patient was able to ambulate unaided by holding onto walls furniture etc. vomiting did hot reoccur after her initial bout. Headache abated on the fifth day. Patient remained "fuzzy" and imbalanced for the next 14 days with occasional mild posterior cranial headache. Rotary nystagmus abated on the 7th day. Note is made that no abnormalities of the tympanic membranes were noted. no cardiac symptoms or irregularities were noted HR 60 BP 110/70 several attempts at epley manuvers only resulted in symptom worsening. Patient felt well enough to traveled by airplane day 8 post dose, having still some "fuzziness 'and slight imbalance, being unable to walk briskly due to gait instability..symptoms worsened slighty after air flight, and on return to home, slight barotraumatic changes were noted in the tympanic membranes, slight fluid levels and some small streaky membrane hemorrhages noted. her gait became slighty more unstable, but she was able to walk unaided. symptoms improved daily and by day 14 symptoms seemed to be much lessened, no nystagmus being noted. vertigo was present only on rapidly standing , position change and vertical looking up., vertigo abating quickly after each motion at rest. Patient traveled by plane on 3/4/21-3/8/21, vertigo escalateed to mild to moderate..no response to epley manuvers. Vertigo worsened daily and Patient again developed mild gait instability and nystagmus bilaterally and vertically. Ear exam was unchanged. no headache was present during this time. Patient was taken for balance training to a specially trained Physical therapist on 3/10/21 for evaluation , Patient being markedly symptomatic, examination showing both right and left ear abnormaities as well as vertical nystagmus. driving was prohibited. The constellation of symptoms for the even are most consistent with acute vestibular neuronitis or central vertigo.. Neuologic localizing signs suggestive of cerebral thrombosis, etc were not present , so MRI was not performed. Patient had Had a Notmal CT scan with here cerebral concussion two years prior. As the symptoms weer worsening and the result of the balance training session on 3/10/21 resulted on significant worsening on awakening on 3/11/21 with moderate gait instability, bilateral horizontal and vertical nystagmus, Prednisone 40MG po was administered. Approximately 8 hours after the prednisone dose, Patient was able to stand unaided, and vertigo was almost totally cleared. 30mg prdnisone was administered on 3/12/21 with Patient being totally asymptomatic. No nystagmus could be detected and epley manuvers done by the physical therapist resulted in no symptons or evoked nystagmus. Predinsone dose was deescalated by 10 mg daily, Patient remaining totally asymptomatic. today 3/16/21 Patient will take 5mg of prednisone, still assymptomatic, prednisone to be discontinued tomorrow.
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| 68 | 2021-03-15 | nausea |
First three days regular side effects, chills, fever, nausea and occasional dizziness (reported on a...
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First three days regular side effects, chills, fever, nausea and occasional dizziness (reported on app to CDC). Day 4 pain in right hip began. By day 7 rash had appeared on right buttocks and hip and below waist on right side. Day 12 formerly diagnosed with shingles.
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| 68 | 2021-03-15 | vomiting, nausea |
Flu like symptoms. Nausea with vomiting. Low grade fever of 100 for 3 days. Aches, pains and chil...
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Flu like symptoms. Nausea with vomiting. Low grade fever of 100 for 3 days. Aches, pains and chilling. Nausea treated with Zofran.
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| 68 | 2021-03-16 | diarrhea, vomiting | Fever, chills, headache, vomiting, diarrhea, lethargic and SOB |
| 68 | 2021-03-16 | blood in stool |
she was so tired; Rash on both arms and inside arms/Rash on Face/rash on front and back of knees; bu...
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she was so tired; Rash on both arms and inside arms/Rash on Face/rash on front and back of knees; burning and itching with bleeding; swelling in lips; Blood in stool/she had blood in her stool, leaking blood around rectum and it had like a burning itch; Blood leaking around rectum/she had blood in her stool, leaking blood around rectum and it had like a burning itch; Face and Neck Burning/hot face and neck was flushed; hot face and neck was flushed; Tingling in tongue, lips, face; Tingling in tongue, lips, face; throat felt tight; lips were puffy; thought she was starting to shake; anaphylactic event; severe allergic reaction; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6199), via an unspecified route of administration in left arm (left shoulder area) on 06Mar2021 17:45 at SINGLE DOSE for COVID-19 immunisation. The patient had no additional vaccines administered on same date of the Pfizer vaccine. The patient had no prior vaccination within 4 weeks. Medical history included upset stomach after eating banana's last year (2020). There were no concomitant medications. The patient had no family medical history relevant to events. The patient previously took bactrim and pneumonia vaccine and experienced anaphylactic reaction to both. On 06Mar2021, the patient experienced anaphylactic event, allergic reaction, face and neck burning, hot face and neck was flushed, tingling in tongue, lips, face, swelling lips, throat felt tight, and lips were puffy. On 07Mar2021, the patient experienced rash, blood in stool, blood leaking around rectum, burning and itching with bleeding. The patient further reported that she had a 'serious life threatening event' after first dose of the Pfizer Covid 19 vaccine on 06Mar2021. Hospital papers say 'anaphylactic event.' Tingling in lips tongue and face, hot face and neck after vaccine, swelling in lips, rash started yesterday evening (07Mar2021), bloody stools for a few hours yesterday evening (07Mar2021) but has resolved. The patient was seen in emergency room (ER) via ambulance. The patient asked if there was a chance the preservative in the vaccine caused her reaction and if the potassium in the vaccine causing her anaphylactic reaction. Additionally, the patient reported that she had a severe allergic reaction this past Saturday to the Covid Vaccine, stated the nurse sent her back to the pharmacist who told her she was having an allergic reaction to the vaccine. The patient reported having a hot face and neck was flushed, after the vaccine, she stated she had tingling in her tongue, lips, and face. And she stated her throat felt tight also, her lips were puffy, and a lot of heat of neck and face, thought she was starting to shake. The patient reported the pharmacist gave EpiPen in thigh and 20 mg tablet of Benadryl and called 911, and took her to the local hospital. Patient also reported that she has not seen this doctor yet she asked to see her and has an appointment with her. The patient also stated that her new PCP was not aware of the reaction to the vaccine at this time. The patient further mentioned that she was still having a rash that broke out. She reported that her tongue was tingling and she still has some swelling in her lips. Patient continues to clarify she still has swelling and some tingling on the tip of tongue and half back on her tongue. She stated that the swelling was persisting and that Benadryl or Prednisone does give some relief but it comes back. Patient mentioned being on a 4 day cycle of Prednisone, takes two in the morning with food. The patient clarified the location of the rash as a rash on both arms that was inside of both of the arms, like a pink rash, she states it was on face and on knees around the front and back of her knees like a red rash. She continues it was on the neck down to the collar bone around the back of her neck, like if she was a bust statue it would be all in that area from the collar bones at that point up and around the back of the shoulder blades. It goes all the way around face and neck. Patient also further reported that she had a scary reaction last night (07Mar2021), she said she had blood in her stool, leaking blood around rectum and it had like a burning itch, when she wiped it was blood, she continued to say when she wiped it was like 'giblets.' She stated was stool, blood, and giblets. Patient stated this lasted for about and hour and half or 2 hours until the stool stopped and it was about 1:30 am before she finally went to sleep, she was so tired on an unspecified date. She stated she took Benadryl right away. She continued to report the bleeding has resolved completely as of this point and reported a regular bowel movement today (08Mar2021). She has two Epi Pens from the drug store that was prescribed but she was afraid to use it, and she thought to see what happens if she uses the Benadryl. She received the Epi shot at the drug store, at (pharmacy), when her reaction broke out, on 06Mar2021, in her thigh, for the allergic reaction. This was her first time ever receiving EpiPen (Lot 029F20AA, expiration Mar2022, and NDC is 0093-5986-27). The ER doctor prescribed her 0.3 mg every 5-15 minutes as needed for anaphylaxis, and not to exceed 3 doses. She received the Benadryl at the drug store, 120mg tablet, first dose was given at drug store. Patient reported she was given prednisone IV in hand through IV at ER, she doesn't know how much that was, then was given Prednisone to go home with- 20mg tablets take 2 a day for 4 days, which she started Sunday morning, 07Mar2021. She was told she experienced a life threatening allergic reaction. Patient was taken to the ER in the ambulance, the paramedic who was with her said she was his first COVID reaction patient. ER doctor told her not to take the second dose of Pfizer vaccine, and to be cautious if taking the EpiPen, she states her heart was racing because of the EpiPen and was told it was because she was not younger that her body did not handle the Epi like younger people do and was told she could have a heart attack from the EpiPen. She was scared because she was not covered fully, since she can't get the second shot of Pfizer, and she was afraid of the Epi Pen, so she was really in a tough spot. ER doctor stated she may be able to take the Johnson and Johnson vaccine, as the second, but she needs to talk to her Primary care about that. The ER doctor continued to tell her it would have to be a special case where she was in a hospital setting in case she has another serious reaction, she was concerned for not receiving the second dose because that means she was not completely covered with one vaccine. She was afraid of the Epi-Pen since she can get a heart attack from it because of her age. The patient mentioned she was tested in Oct (clarified as 14Oct2020) for Covid due to having a viral infection at that time but was negative. Added the ER paper work says ED anaphylaxis. The patient wanted to ask about finding out the ingredients in Pfizer vaccine and the ingredients in the Johnson and Johnson vaccine. She saw the list on the fact sheet of Pfizer's ingredients and in a few places it says Potassium, 3 different ingredients, and several months ago, she quit eating bananas, bananas have potassium, and they were giving her stomach upset, diarrhea, she used to eat them all her life, she noticed that there was a lot of potassium in the medicine. Doctor wanted to know if she would be able to take the Johnson and Johnson vaccine. He said if she got the second shot, of the Johnson and Johnson, that it would have to be a special case, like in a hospital setting, and there would have to be medical people in a medical center, to take care of her was she has a reaction to it as well. He advised that she take the Johnson and Johnson than not taking it, because by not taking it, she was very vulnerable to catching COVID 19. And patient wanted to know was it a preservative that was causing the reaction. It was reported that rash began around 10PM, bloody stool began between 11 PM and 12:30 AM, all other symptoms within 15-20 minutes, it began around 6PM, maybe sooner 5:55 PM, she was in denial, it felt like tongue and lips tingling, she did have a reaction before to a different shot. The anaphylactic reaction required emergency room visit. Patient was not hospitalized and was in observation in ER. On 08Mar2021, the patient recovered from blood in stool, rectal bleeding, and burning and itching with bleeding. The patient had not yet recovered from severe allergic reaction, hot face and neck was flushed, tingling in tongue, lips, face; lips were puffy, and rash. The outcome of throat felt tight, thought she was starting to shake, she was so tired, and swelling in lips was unknown.
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| 68 | 2021-03-16 | vomiting, abdominal pain upper |
Stomach cramps, vomiting, chills 4 hours Sleep disturbance and fatigue for 6 days Headaches 4 days. ...
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Stomach cramps, vomiting, chills 4 hours Sleep disturbance and fatigue for 6 days Headaches 4 days. Handled by Ibuprofen or aspirin
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| 68 | 2021-03-17 | nausea |
Injection site pain12 hours after then chills fever up to 100 for almost 36 hours. Body aches especi...
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Injection site pain12 hours after then chills fever up to 100 for almost 36 hours. Body aches especially back hips neck . Itchy rash at end of fever andafter fever subsided lasted for five days. I typically with fever get a rash. Nausea, body aches all over swollen neck glands
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| 68 | 2021-03-18 | abdominal pain upper, retching, GERD, diarrhea |
She had the vaccine at the facility where she lives. She fainted less than 24 hours after the vacci...
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She had the vaccine at the facility where she lives. She fainted less than 24 hours after the vaccine, got up from that and had dry heaves, lost her speech and had loose stools. The aide caught her as she was fainting as she would have fallen on the floor. She said it was weird, she looked at people and it looked like they were 2 dimensional and knew something was wrong, but couldn't figure out what as they attended to her. They asked her questions, but she was not able to speak to them. They apparently spent 2 hours with her, but she doesn't believe it was that long, and then they knew she wanted to go to one Hospital and not the other. She had been loosing words before this happened, but not as bad as this one. This was about the same reaction that she had when she got the COVID virus in January. She was then taken to the hospital where she was given fluids and hydrated her and checked her heart, saw a cardiologist and a neurologist to see if those things caused the fainting and had blood work done. They also did a CAT Scan of her head and neck. They told her that she was fine and was discharged back home after 5 days, which was 3/11/21. Since then she has been very tired, she does have GERD and her stomach has been hurting a lot as well.
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| 68 | 2021-03-18 | abdominal pain, nausea, diarrhea |
Extreme nausea, abdominal cramping, diarrhea, dizziness. Also headache and warm face (low fever) occ...
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Extreme nausea, abdominal cramping, diarrhea, dizziness. Also headache and warm face (low fever) occurring for 2 hours , beginning 4 hours after vaccination. Then a little less severe for the following 2 hours. Then further diminishing over the next four hours. Felt OK after 12 hours.
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| 68 | 2021-03-18 | diarrhea | One day of extreme fatigue Two following days of diarrhea No treatment beyond Kaopectate |
| 68 | 2021-03-18 | diarrhea |
Within two hours had headache, violent diarrhea, clammy skin and sweating. Light headed to the point...
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Within two hours had headache, violent diarrhea, clammy skin and sweating. Light headed to the point of almost fainting. I called 911 which I never would do normally but there was no one but me and I wasn?t sure what was happening. Medics took vitals and all was ok. By the time they arrived I was shaky but all other symptoms had gone.
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| 68 | 2021-03-18 | nausea | Nausea joint pain muscle pain headache tiredness |
| 68 | 2021-03-19 | diarrhea, vomiting |
3:00 am woke up and vomited, Continued to wake up with 3 bouts of diarrhea, had chills & fever of ...
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3:00 am woke up and vomited, Continued to wake up with 3 bouts of diarrhea, had chills & fever of 101, slept in until 10:00, got up and took 1st dose of ibuprofin, felt achy and very lethargic all morning and afternoon, Continued to take doses of ibuprofin, Fever came down and some achiness went away due to ibuprofin, felt better by evening (24 hrs. after shot) but still had slight fever and still fatigued. By morning of 3/20 I felt much better.
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| 68 | 2021-03-20 | decreased appetite |
Fever/chills, headache, weakness, dizziness, fatigue, loss of appetite. Woke feeling feverish around...
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Fever/chills, headache, weakness, dizziness, fatigue, loss of appetite. Woke feeling feverish around 1:30 am (about 16 hours after vaccination). Began feeling better around 5:30 pm (about 34 hours after vaccination). Symptoms not as bad as after first dose and didn't last as long. As of 8:30 am on second day after vaccination (49 hours), feel about 90% back to normal.
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| 68 | 2021-03-20 | nausea |
Next day nausea; severe back pain./Back pain lasted two days; Within 2 hours experienced dizziness; ...
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Next day nausea; severe back pain./Back pain lasted two days; Within 2 hours experienced dizziness; severe headache./After a week still have a headache.; Slight arm soreness; Severe exhaustion and slept 12-15 hours the first three days after shot.; Severe exhaustion and slept 12-15 hours the first three days after shot.; This is a spontaneous report from a contactable consumer. a 68-year-old female patient (consumer) received first dose BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection) via an unspecified route of administration (anatomical location: arm left) on 03Feb 2021 at 12:15 pm at single dose for COVID-19 immunisation. Patient Medical history included low thyroid. The patient's concomitant medication included levothyroxine. It was reported that no other vaccine was given within Four weeks prior to the vaccination. On 03Feb 2021 at 02:15 PM (same day of vaccination) Within 2 hours patient experienced dizziness and severe headache. Slight arm soreness. Next day nausea and severe back pain. Back pain lasted two days. Severe exhaustion and slept 12-15 hours the first three days after shot. After a week still have a headache. The patient prescribed treatment with Ibuprofen, tylenol and meloxicam. Since the vaccination, the patient had not been tested for COVID-19. The outcome of event headache was not recovered and other events was Recovering. Information on Lot/Batch number has been requested
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| 68 | 2021-03-21 | nausea, vomiting |
Blacked out completely while driving home on the highway about 50 minutes after the vaccine was admi...
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Blacked out completely while driving home on the highway about 50 minutes after the vaccine was administered with no reactions during the observed waiting period.. After awakening, nauseated, vomiting, woozy, dizzy, felt extremely cold, drained, somewhat unclear. Friend in vehicle was able to get to the steering wheel and we went off road into trees and grass on the side of the road several hundred feet until she was able to stop the vehicle. I did not come to until after the vehicle stopped. First responders came, reports made. Examined and tests done at Emergency room.
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| 68 | 2021-03-21 | nausea | fatigue, nausea, headeache, extreme cold and pain in arm. |
| 68 | 2021-03-21 | vomiting |
I had chills, a low grade fever, and vomiting, and was extremely fatigued, which lasted about 2 days...
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I had chills, a low grade fever, and vomiting, and was extremely fatigued, which lasted about 2 days. NOTE: The same symptoms occurred with my first vaccine on February 26, 2021.
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| 68 | 2021-03-22 | nausea |
Had the injection 3/21/2021 at 2:30. On 3/22/2021, the next morning after the injection had nausea,...
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Had the injection 3/21/2021 at 2:30. On 3/22/2021, the next morning after the injection had nausea, flu-like symptoms, and slept all day. Took two advil and one tylenol at 6:30 am, 2:00 pm and again at 10 pm. On 3/23/2021, woke up 7 am in the morning and felt fine.
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| 68 | 2021-03-22 | nausea |
very painful arm for a week, nausea, muscle pains and weakness, sharp pains in knees, dizziness, bra...
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very painful arm for a week, nausea, muscle pains and weakness, sharp pains in knees, dizziness, brain fog, all my skin felt like it a bad sunburn its still not back to my normal state, cronic sinus issues for about 2 weeks with headaches,
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| 68 | 2021-03-23 | abdominal discomfort |
Low grade fever(100.6) for 20 hours, controlled by Tylenol; upset, queasy stomach and very tired for...
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Low grade fever(100.6) for 20 hours, controlled by Tylenol; upset, queasy stomach and very tired for same time frame. No other symptoms.
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| 68 | 2021-03-23 | decreased appetite, abdominal discomfort |
Headache, sore arm, fatigue, muscle pain, racing heart rate, difficulty breathing Fever (high of 101...
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Headache, sore arm, fatigue, muscle pain, racing heart rate, difficulty breathing Fever (high of 101.9) Body ache Chills Upset stomach/ no appetite
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| 68 | 2021-03-23 | decreased appetite, stomatitis |
Exacerbation of chronic fatigue, "burning" eyes, "brain fog", chills, metallic taste in mouth, mouth...
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Exacerbation of chronic fatigue, "burning" eyes, "brain fog", chills, metallic taste in mouth, mouth sores, decreased appetite.
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| 68 | 2021-03-23 | nausea |
Was at home, felt Dizziness,fainting,fever,strong headache,fatigue,cold sweat,body ache,clammy skin,...
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Was at home, felt Dizziness,fainting,fever,strong headache,fatigue,cold sweat,body ache,clammy skin,nausea, short of breath ,dry mouth ,dehydrated, very bad I though Iwas going to pass out at any time,weak.
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| 68 | 2021-03-23 | stomatitis, nausea |
The evening of the inkection I felt nauseated. The next morning I had fever and chills (100 F) and f...
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The evening of the inkection I felt nauseated. The next morning I had fever and chills (100 F) and fatigue. The next morning I had lymphedema on the rt side of my jaw and down my anterior neck. The next day I developed a large ulcerated area at the back of my throat on the right with intense ear pain. I went to the clinic and a covid test was done (I don't have the results yet). Today (7days after the injection) I returned to the clinic because my throat ulcer had gotten larger and spots were appearing on the roof of my mouth. I again ran a low grade fever. I was again diagnosed with either a viral infection or an unusual immune response to the vaccine.
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| 68 | 2021-03-24 | abdominal pain |
After 1st shot : Platelets down to 140k; splenic discomfort /pain; This is a spontaneous report from...
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After 1st shot : Platelets down to 140k; splenic discomfort /pain; This is a spontaneous report from a contactable nurse (patient herself). This 68-year old female patient receive her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), lot number EL 9262, via unspecified route of administration on the left arm on 05Feb2021 at 3:30 PM (at the age of 68-year old) at single dose for COVID-19 immunization. Relevant medical history included allergy to NSAIDs, cephalosporin and bee stings, Epstein-Barr virus infection (EBV), chronic obstructive pulmonary disease (COPD), drug induced immune thrombocytopenia (ITP) with NSAIDs and Rebetrol/Interferon), "T&A", tubal ligation, cholecystectomy and osteoporosis. Concomitant medications included zinc, Vit D3, probiotics and calcium. After first shot, on an unspecified date in Feb2021, the patient experienced platelets down to 140k, (Hx of drug induced ITP), splenic discomfort/pain. No treatment was given to the patient for the events. The outcome was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Platelets decreased cannot be excluded. However, the medical history of drug induced immune thrombocytopenia (ITP) with NSAIDs may provide a plausible alternative explanation for the event. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : PFIZER INC-2021264907 same reporter/patient, different dose of COVID-19 vaccine/event
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| 68 | 2021-03-24 | vomiting, nausea, decreased appetite |
Nausea, vomiting, bad vertigo, (fell) sweating, chills and freezing, temp 101, headache, eyes blurry...
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Nausea, vomiting, bad vertigo, (fell) sweating, chills and freezing, temp 101, headache, eyes blurry and could not focus on anything- trouble standing up and not falling over- started at 6:30 Sunday morning and gone by 1 - except very fatigued, (slept mostly for 3 days) shaky (trembling) , no appetite , headache and chills- lasting thru to Thursday morning. Was very scary!
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| 68 | 2021-03-25 | abdominal discomfort, gastrointestinal disorder, diarrhea |
Tiredness; sore arm; stomach and intestinal issues; Diarrhea; very unsettled stomach; This is a spon...
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Tiredness; sore arm; stomach and intestinal issues; Diarrhea; very unsettled stomach; This is a spontaneous report from a contactable consumer (patient). This 68-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 12Feb2021 at 13:45 (at the age of 68-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included breast and colon cancer, thyroid surgery, controlled blood pressure (BP), and diabetic. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to the vaccine the patient was not diagnosed with COVID-19. Concomitant medications included trastuzumab (HERCEPTIN) infusions every 3 weeks from an unspecified date for cancer, pertuzumab (PERJETA) from an unknown date for cancer, anastrozole from an unknown date for cancer, levothyroxine sodium (SYNTHROID) from an unknown date for thyroid surgery, nadolol from an unknown date for controlled blood pressure, linagliptin (TRAJENTA) from an unknown date for diabetic, pantoprazole (PROTONIX) from an unknown date for an unknown indication, cetirizine (ZYRTEC) from an unknown date for an unknown indication, and "vita" from an unknown date for an unknown indication. The patient previously received penicillin, aspirin, and medications from yew pine tree from unspecified dates for unspecified indications and experienced allergy. On 06Feb2021 (as reported) the patient experienced tiredness. On "day 2" the patient experienced sore arm, stomach and intestinal issue, diarrhea and very unsettled stomach. The event were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of tiredness and sore arm were recovered on an unspecified date. The outcomes of stomach and intestinal issues, diarrhea and very unsettled stomach were recovered on "day 5". It was also reported that since the vaccine, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
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| 68 | 2021-03-25 | decreased appetite | Chills body aches headache fever 102.8 no appetite very thirsty |
| 68 | 2021-03-25 | difficulty swallowing |
a few hours after getting the vaccine, my throat started burning, hard to swallow, then cough, low f...
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a few hours after getting the vaccine, my throat started burning, hard to swallow, then cough, low fever, body aches which continued from the 15th untill today 26th. lost 12 lb during this time, Weakness. Have never been this sick! My husband also had the same shot, same day, and started getting ill 5 days later, Cough, fever, nausea, unable to sleep. He is still ill today with dry heaves.
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| 68 | 2021-03-25 | nausea |
Awoke approx 6AM. Took daily synthroid went back to sleep woke up feeling nauseous and dizzy went to...
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Awoke approx 6AM. Took daily synthroid went back to sleep woke up feeling nauseous and dizzy went to bathroom felt like I needed to sit down next I remember I woke up on the floor with cut over my left eye.
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| 68 | 2021-03-26 | diarrhea |
All adverse effects have lasted for six (6) plus days post-injection unless otherwise indicated: inj...
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All adverse effects have lasted for six (6) plus days post-injection unless otherwise indicated: injection site arm sore, fatigue, sleepiness, joint pain, diarrhea, bad nightmares for four (4) nights and bad dreams (unusual for me) for two plus nights after (I had nightmares after the first covid shot, too), minor dizziness for three days, chills, depression.
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| 68 | 2021-03-26 | nausea, decreased appetite |
Fever, headache, flu-like aches and pains--joint pain, miscellaneous stabbing/throbbing pains, nause...
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Fever, headache, flu-like aches and pains--joint pain, miscellaneous stabbing/throbbing pains, nausea, loss of appetite
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| 68 | 2021-03-26 | nausea | Extreme Fatigue, brain fog, nausea, headache, body aches for 5 days |
| 68 | 2021-03-29 | nausea |
pt states that immediately after taking the vax she got light headed and her limbs felt very very he...
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pt states that immediately after taking the vax she got light headed and her limbs felt very very heavy. Her BP was up to 192/90. They had her sit to monitor her BP and she became nauseas. She went to the ER. They continued to monitor her BP and she was given IV Benadryl. The heaviness in her limbs lasted many hours. Once her dizziness, heaviness in limbs, and her BP was 141/67 and still coming down she went home. Walking to her vehicle she had the dizziness, heaviness and was light headed again. When she got home she went to bed. Pt woke up having heart palpations. No chest pain or SOB. These palpitations lasted about 15 minutes. On 3/30/2021 she has some fatigue and a tightness around the top of her head. Pt has a FU appt w/ PCP on 3/31/2021.
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| 68 | 2021-03-30 | nausea, abdominal pain upper, vomiting |
Nausea; Vomiting; Chills; Stomach pain; Slight headache; Uncontrollable shaking; This is a spontaneo...
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Nausea; Vomiting; Chills; Stomach pain; Slight headache; Uncontrollable shaking; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 68-year-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247, Expiry date: unknown) via an unspecified route of administration, administered in Left arm on 28Jan2021 at 14:00 (at the age of 68-years-old) at a single dose for covid-19 immunisation. Medical history included bronchiectasis and dysthymia. Allergies to medications, food, or other products included Rash with amoxicillin. Concomitant medication patient received within 2 weeks of vaccination included sertraline hydrochloride (ZOLOFT) and ovata (METAMUCIL [PLANTAGO OVATA]). The patient previously took amoxicillin and experienced rash. The patient experienced nausea, vomiting, chills, stomach pain, slight headache and uncontrollable shaking on 28Jan2021 at 21:30 PM. The event was considered as non-serious. The most recent COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The patient was recovering form all the events.
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| 68 | 2021-04-02 | diarrhea |
Fatigue; soreness at injection site; warmth at injection site; diarrhea; This is a spontaneous repor...
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Fatigue; soreness at injection site; warmth at injection site; diarrhea; This is a spontaneous report from a contactable nurse (patient). A 68-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EL9269) via an unspecified route of administration, administered in left arm on 07Feb2021 14:15 (at the age of 68-years-old) as single dose for COVID-19 immunization. The patient medical history included Hypertension, Atrial fibrillation, Mitral Valve Prolapse. No known allergies. The patient concomitant medications included Lisinopril, Metoprolol, Eliquis, Calcium, Biotin. On 08Feb2021 09:00 AM patient experienced fatigue, soreness at injection site, warmth at injection site, diarrhea. No other vaccine in four weeks. No COVID tested post vaccination. No COVID prior vaccination. No treatment received. The outcome of the event was not recovered.
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| 68 | 2021-04-06 | nausea, vomiting |
Fever chills nausea from 10.30 pm 23 march 2021. Wednesday same. Wednesday evening extreme nausea vo...
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Fever chills nausea from 10.30 pm 23 march 2021. Wednesday same. Wednesday evening extreme nausea vomitting fever severe trembling and chills. During the night nightmares and migraine woke me up. Tried to go to the bathroom but collapsed and knocked my head on the wall. Could not get up crawled to the bathroom and tried to pull myself up but fell headfirst and hit my nose and cheek on the toilet. Cut nose and hurt cheek bone. Felt terrible head spinning and unable to get up/ Crawled to bed; Live alone. Could not even find the telephone; Woke up and tried to get up. Freezing cold. Finally called Ambulance Their doctor refused to send an ambulance and said " go to your GP its not an emergency". I was disgusted barely could walk but somehow drove to the GP. he was closed so went to emergency. the Dr in charge of the vaccination center was there but did not accept it was the vaccine; Finally on the verge of collapse another lady took me to the entrance of emergency. I was finally seen:; Same thing. Dr there told me its not an emergency and to go and see my GP. I was so sick and told him th eGP was not there; His reply " There are plenty of others to see" It was the nurse who persisted and even thought may be I had covid and did the PCR test. I started uncontrollably shivering and was freezing. I had a fever. they did blood tests lung x ray and finally a urine test, Full of blood leucocytes and protein. The same wonderful nurse said its bad. I was by then vomitting again and thought I would die; Uncontrollable shivering ; taken to the lab or a pelvic cat scan;Couldnt even get to sip water. SEVEN hours later the same DR who told me I was not an emergency came in and said " You will have to be hospitalised as you have a serious kidney infection. Acute pyelonephritis. I vomitted on him! Taken to a ward 25 March until 29 March. Rocephin antibiotics. Allergy to that too with migraines and skin rash; They changed the antibiotics. After five horrible days I finally went home on antibiotics Ofloxacine
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| 68 | 2021-04-07 | loss of appetite |
Patient transferred from outlying hospital on 3/30/21 due to increasing oxygen demands and increased...
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Patient transferred from outlying hospital on 3/30/21 due to increasing oxygen demands and increased level of care. Patient was admitted to outlying hospital with COVID-19 infection with shortness of breath, cough, fever, weakness, fatigue with decreased oral intake on 3/28/21. Patient required oxygen and was treated with remdesivir, steroids, and antibiotics. Patient was discharged to home with oxygen.
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| 68 | 2021-04-08 | abdominal pain, appendicitis |
Was given 2nd shot March 22 and within 12 hours I had what I would call shooting nerve pain on t...
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Was given 2nd shot March 22 and within 12 hours I had what I would call shooting nerve pain on the level pain of shingles except it was everywhere. Next day I hurt all over. Wednesday some recovered, Thursday I went to work. Friday I would have said I was 100% till 3:30pm. I had adominal pain. Went to ER and was diagnoised with appendicitus. Had surgery next morning.
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| 68 | 2021-04-11 | diarrhea, nausea |
After the first dose on 2/16/2021, approximately 6-7 days later, I felt queasy and the smell and ta...
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After the first dose on 2/16/2021, approximately 6-7 days later, I felt queasy and the smell and taste of food was distasteful. For two days, unable to eat anything but broth and oatmeal. After the second dose on 3/9/21, similarly, after 6-7 days same symptoms, however, to date, they have not subsided. Food and liquids (even water and fizzy water) tastes funny, flat. The smell of most food is nauseating, and in the last few days I have had some explosive diarrhea, now just loose stools. For the last 3 days have felt dizzy; not constantly, but if I move my head quickly or bend over. I did not have covid at the time of vaccination; I have had 8 covid tests in 2021 due to medical procedures and flying.
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| 68 | 2021-04-17 | nausea |
feels tired; She did have palpitations overnight that woke her up in her sleep for 15 minutes; head ...
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feels tired; She did have palpitations overnight that woke her up in her sleep for 15 minutes; head feels tight, like there is a band around it/head feels tight, like there is a band around it; Nausea; severely lightheaded; her limbs felt heavy; her blood pressure went way up and lasted a good 7 hours/blood pressure at this time was elevated to 190/86; it was hard to lift her arms; This is a spontaneous report received from a contactable two nurses (one nurse reported for herself). This 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6205 and expiration date: 30Jun2021), via an unspecified route of administration right arm on 29Mar2021 at 10:15 as single dose for COVID-19 immunization. Medical history included anaphylaxis (recovering), hypertension ongoing, gastroesophageal reflux disease (GERD), anemia (her hemoglobin dropped to 6.9 and ferritin was low), hiatal hernia surgery (had mesh), a latex allergy (her lips would start swelling) and food allergy (tuna fish). Family history included lung disease (her dad was diagnosed). Concomitant medications included hydrochlorothiazide (HCTZ) 25 mg, daily (been on it for 10 years) taken for high blood pressure from an unspecified start date and ongoing; losartan 100 mg, daily (for about 10 years) taken for hypertension from an unspecified start date and ongoing; iron (Tablet) 65 mg, daily (about 10 years ) taken for anaemia, cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication; The patient previously took cefalexin (KEFLEX) and experienced swelling on face and mouth, epipen, acetylsalicylic acid (ASPIRIN) (6 years ago aspirin sensitivity took place) and experienced haematuria, tolectin as nonsteroidal anti-inflammatory drug (NSAIDS) (about 30 years ago (received steroids, breathing treatments and benadryl) and experienced anaphylactic reaction, flu vaccine taken for flu (at 19 years old). The patient got first vaccine on 29Mar2021 and had an event. On the same day, she was severely light headed and her limbs felt heavy and her blood pressure went way up and lasted a good 7 hours. They had her in the emergency room. She did have palpitations overnight that woke her up in her sleep for 15 minutes but she had no chest pain or shortness of breath and then it went away. At first, she didn't feel anything, but then as soon as she got up to go to the sitting area where she was supposed to wait for 15 minutes, she became very very light headed, almost like there was a band around your head. there was no dizziness, but she was lightheaded and all four of her limbs felt really heavy, it was hard for her to move her limbs, she experienced nausea while sitting in the waiting area as well. She did not throw up and it started about an hour after the vaccine and describes the nausea as fleeting and states it lasted about a couple of hours, but not as long as the light headedness and heavy limbs. her blood pressure at this time was elevated to 190/86. the doctor there told them to send her to the ER. The reporter stated that the vaccine was given at the hospital, so they just wheeled her to the emergency department within the hospital, the doctor in the emergency room told her they didn't think it was an allergic reaction. after about 6 hours around 1600 her blood pressure finally came down to 141/67. She was discharged from the emergency room around 16:00 on 29Mar2021. At the time of discharge, the heaviness of limbs and light headedness had went away, but when she was walking to get to her car in the parking lot the lightheadedness and heaviness of her limbs returned. it was hard to lift her arms. she went home and went to bed, the lightheadedness and heaviness of her limbs went away after she was able to lay down and rest. Last night around 2:30 or 3:00am she woke up with heart palpitations. Caller states that these palpitations went away after 15 min and that she hasn't had this experience in years since hiatal hernia surgery. she felt much better next day, the only thing she felt today was tightness in her head but not a headache and just felt tired. The outcome of the events severely lightheaded, her limbs felt heavy, her blood pressure went way up and lasted a good 7 hours/blood pressure at this time was elevated to 190/86 and head feels tight, like there is a band around it were recovered in 2021; nausea was recovered on 29Mar2021; palpitations was recovered on 30Mar2021 and other events were unknown. As reported causality : Feeling light headed; Limbs felt really heavy; high blood pressure Related; head feels tight, like there is a band around it; heart palpatations Related. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the reasonable temporal association, the Company cannot completely exclude the possible causality between the reported events and the administration of the suspect COVID19 vaccine, BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 68 | 2021-04-17 | vomiting |
19 second pause of no heartbeat and in third degree heart block; 19 second pause of no heartbeat and...
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19 second pause of no heartbeat and in third degree heart block; 19 second pause of no heartbeat and in third degree heart block; Awoke to throw up; Thinks she fainted; Oxygen level of 93 on oximeter; she wasn't feeling well; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 22Mar2021 at 15:00 (Lot Number: EN6198) as single dose for covid-19 immunization. Medical history included mild stroke from 18Jan2020 and not ongoing, suspected she had atrial fibrillation and she had a heart monitor placed 21Feb2020. Her heart monitor never showed Atrial Fibrillation after one year of being monitored. Ongoing low thyroid/hypothyroidism and blood cholesterol increased from an unknown date. Concomitant medications included levothyroxine taken for low thyroid/hypothyroidism from an unspecified start date (started probably been 10 years) and ongoing; atorvastatin taken for reduce cholesterol from 2020 (started right after she had stroke, either Jan2020 or Feb2020) and ongoing. No additional vaccines administered on same date of the Pfizer suspect. No prior Vaccinations (within 4 weeks). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 01Mar2021 (at age of 68 years old, Lot Number: EN6200) as single dose for covid-19 immunization. She was fine right after the first dose. She only had a sore arm for 3 days. Just last week, she had a severe adverse reaction right after her vaccine. With the second dose, she had everything possible. Twelve hours after, on 23Mar2021 at 03:00, she awoke to throw up. She thinks she fainted. She had to throw up 2 more times that night. She had been wearing a heart monitor. On 24Mar2021 her cardiologist called her and told her she had a 19 second pause of no heartbeat and was in a 3rd degree heart block. The very next morning, they put in a pacemaker. She was overall healthy and athletic. She was a runner and golfs all the time. She had an outpatient procedure for the pacemaker placement at the hospital on 25Mar2021. She was still recovering but improving. Caller added it was scary when your heart stops. Caller added she did not see this as a possible related side effect, but that evening when she was not feeling well, 22Mar2021, she checked her oxygen level with her oximeter. It was 93 and usually runs around 99. It is back to normal now. She checked it the night she was vomiting. Stated this was before the third degree heart block by a few hours. She did not think it was related. All her symptoms are gone other than the placement of her pacemaker. The outcome of the events " 19 second pause of no heartbeat and in third degree heart block" was recovering. The outcome of the event " Oxygen saturation decreased" was recovered. The outcome of other events was unknown.
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| 68 | 2021-04-24 | abdominal pain upper |
has pain in the right side of her stomach when sneezing and coughing; has pain in the right side of ...
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has pain in the right side of her stomach when sneezing and coughing; has pain in the right side of her stomach when sneezing and coughing; pain in the right side of her stomach when sneezing and coughing, and a very deep pain upon movement; slight dizziness; This is a spontaneous report from a Pfizer-sponsored program. A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0158), via an unspecified route of administration, administered in deltoid left on 06Apr2021 at 12:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 (had coronavirus last year) on an unspecified date in 2020, blood pressure and blood cholesterol abnormal, sleep disorder, prophylaxis for heart disease, hypertension and premature ventricular contractions (PVCs) from an unknown date and unknown if ongoing. Concomitant medications included amlodipine; olmesartan medoxomil taken for hypertension; acetylsalicylic acid, ascorbic acid (ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]) taken for prophylaxis; atorvastatin calcium taken for blood cholesterol; metoprolol taken for hypertension; melatonin taken for sleep disorder, all from an unspecified start date and ongoing. She has taken medication for blood pressure and cholesterol for years and never had this type of pain. She takes amlodipine, olmesartan medoxomil and was taking Bystolic before and it was working ok but she would have PVC's and that was discontinued, and she was placed on metoprolol. The PVC's are better, better control over the PVC's. Clarified she had the PVC's before the medications. The patient previously received a flu vaccination for influenza immunization and got soreness at the injection site. Reporter stated that on her right side when she presses down in the area, she feels it a lot, has pain in the right side of her stomach when sneezing and coughing, and a very deep pain upon movement. These started mildly several hours after the vaccine on the same day and then progressively got worse over the last 2 days, 07Apr2021 was very bad and 08Apr2021 also and she still has it this morning. It let up a bit this morning. The slight dizziness started the same day as the vaccine a few hours later and has stayed about the same, it may be improving a little she thinks as she didn't really evaluate it this morning, but she thinks it might be a little better. The dizziness she knows you can have light dizziness as a side effect from the vaccine and it is not serious, it can be a normal side effect for people, that most people she has spoken to didn't have dizziness. The pain is a little less today, she is moving around now, and it has lessened to some degree, it is not as severe as yesterday or the day before. She didn't know if her liver was being affected or what, it is in that area. She feels her symptoms are 100% related to the vaccine. Consumer stated, "I took Pfizer COVID vaccine on 06Apr (06Apr2021) and after that I started feeling dizziness and pain in my stomach area or abdomen area and now the third day it is really bad. All I had was the Pfizer COVID Vaccine." When paraphrased the concern, consumer stated, "Yes, It is in my stomach area." The events coughing, sneezing and stomach pain were considered medically significant by the reporter. The outcome of the event slight dizziness was recovering, while of the rest was not recovered.
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| 68 | 2021-04-24 | appendicitis |
appendicitis; sore; tired; with in 12 hours I started with nerve pain on the level of shingle pain e...
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appendicitis; sore; tired; with in 12 hours I started with nerve pain on the level of shingle pain except it didn't stay in one part of the body.; This is a spontaneous report from a contactable consumer (reported for herself). A 68-years-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6199), administered in right arm via an unknown route of administration on 22Mar2021 at 09:00 am as SINGLE DOSE for covid-19 immunization. The patient previously took first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6200), administered in right arm via an unknown route of administration on 27Feb2021 at 08:00 am. The patient medical history included blood pressure measurement. Concomitant medications in two weeks included Olanzapine 2.5mg, Olmesartan 20mg and Zetia 10mg. The patient had drug allergies for Codeine and Demerol. On 22Mar2021 within 12 hours, the patient started with nerve pain on the level of shingle pain except it didn't stay in one part of the body. The whole body was affected. Next day on 23Mar2021, the patient was sore and tired. On 26Mar2021 at 3:30 pm, the patient had abdominal pain and went to hospital at 09:00pm because of pain and was diagnosed with an appendicitis. The treatment for the events included appendectomy surgery to remove the next morning. There was no other vaccine in four weeks. On 26Mar2021, the patient was tested for covid with nasal swab post vaccination which was negative.The patient was hospitalized for 2 days for all the events. The outcome of the events was recovering.
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| 68 | 2021-04-24 | nausea |
fever 103.4; Injection site pain; tiredness; headache; chills; joint pain; nausea; This is a spontan...
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fever 103.4; Injection site pain; tiredness; headache; chills; joint pain; nausea; This is a spontaneous report from a contactable consumer reporting for herself. A 68-year-old non-pregnant female patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 30Mar2021 at 10:45 (Batch/Lot number was not reported) as a single dose (at the age of 68-years-old) for covid-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing, and high cholesterol from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included pravastatin at 40mg taken for an unspecified indication, start and stop date were not reported; benazepril at 20mg taken for an unspecified indication, start and stop date were not reported; and esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) at 40mg taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced fever 103.4 on 31Mar2021 at 20:30, injection site pain on 31Mar2021 at 20:30, tiredness on 31Mar2021 at 20:30, headache on 31Mar2021 at 20:30, chills on 31Mar2021 at 20:30, joint pain on 31Mar2021 at 20:30, and nausea on 31Mar2021 at 20:30 with outcome of unknown. The patient underwent lab tests and procedures which included body temperature: 103.4 on 31Mar2021. Treatment was not received for any of the events. The outcome of the events fever 103.4, injection site pain, tiredness, headache, chills, joint pain, and nausea was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 68 | 2021-04-27 | nausea |
4-23-21 Discomfort at injection site, otherwise feeling very good. 4-25-21 At approx. 10 PM exper...
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4-23-21 Discomfort at injection site, otherwise feeling very good. 4-25-21 At approx. 10 PM experienced rapid onset of acute nausea and mild vertigo. 4-26-21 After a sound night's sleep by 7 AM, the above (4-25) symptoms diminished. However, by 10 AM nausea symptoms became acute AND vertigo symptoms markedly increased, making the room look like it was spinning. Patient was able to bed rest until 1 pm and felt much better with symptoms markedly diminishing to low level 'dull nausea'. 4-27-21 After sound sleep, all above symptoms tapered off, leaving patient with very low energy level, yet able to perform ADLs--and feeling more homeostasis by 8 PM.
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| 68 | 2021-04-27 | nausea |
Asthma flare up; dry, hacky cough; pain and tightness in her chest; pain and tightness in her chest;...
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Asthma flare up; dry, hacky cough; pain and tightness in her chest; pain and tightness in her chest; nausea feeling in her chest; She gets this laryngitis; has trouble talking; She wants to make sure its not going into like a viral pneumonia; Flu-like symptoms; fever; achy; fatigue; Sore arm; Headache; This is a spontaneous report received from a contactable pharmacist (patient). A 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: CER230) via an unspecified route of administration on 24Mar2021 at 11:30 (at the age of 68-years-old) as a single dose in the right arm for COVID-19 immunisation. The medical history included flu and suspected COVID-19 both in Jan2020 to an unspecified date (she had a bad flu back in Jan2020, which could have been COVID because it was such a bad flu, over a year ago), ongoing asthma from an unspecified date (mild asthma) and chest nausea in Jan2020 to an unspecified date. The patient had no history of any adverse events following prior vaccinations. Medical history (including any illness at time of vaccination) was also reported as none. Family medical history relevant to the adverse event included an uncle that had asthma, but no one else had breathing issues. Concomitant medications included fluticasone propionate/salmeterol xinafoate (ADVAIR) and ipratropium bromide/salbutamol sulfate (DUONEB), both ongoing and taken for asthma on unspecified dates. Other products were also reported as "no". The patient did not receive any prior vaccinations within 4 weeks prior to the COVID-19 vaccine and did not receive any additional vaccines on the same date as the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: 3N6202) via an unspecified route of administration on 24Feb2021 at 11:30 (at the age of 68-years-old) as a single dose in the left arm for COVID-19 immunisation. On 24Mar2021 the patient experienced sore arm and headache; on 25Mar2021 the patient experienced flu-like symptoms, fever, achy, fatigue; on 02Apr2021 the patient experienced asthma flare up, dry, hacky cough, pain and tightness in her chest, nausea feeling in her chest; on unspecified dates in Apr2021 the patient experienced she gets this laryngitis, has trouble talking and she wants to make sure its not going into like a viral pneumonia. The reporter classified the events headache and flu-like symptoms as non-serious. The patient called to report that she had an asthma flare up 10 days (as reported) after her second dose of COVID-19 vaccine on 24Mar2021. The patient stated that she did not get a flare up often, she had mild asthma. She usually got mild flare-ups since she did not have severe asthma. She stated it could be something else, but she had not had a flare-up like this since she had a bad flu back in Jan2020, which could have been COVID-19 because it was such a bad flu. That was over a year ago. She received her second vaccine on 24Mar2021, and the asthma flare up and hacking cough started on 02Apr2021. On the night of 24Mar2021, she started with a headache. She had the shot at 11 something and by that evening before she went to bed, she had a headache and a sore arm, but that was no big deal. Then on 25Mar2021, she started with flu like symptoms/fever. The headache persisted through that as well. At that point, she did not have tightness or the dry, hacky cough. By the middle of the day on 27Mar2021, her flu-like symptoms were gone. She would consider these to be "non-serious", it was what she expected, as it was seen from the paperwork of the vaccine. By 28Mar2021, all of her symptoms were gone prior to the flare-up. She had typical flu-like symptoms: fever, headache, achy, fatigue on the 2nd, 3rd, and into the 4th day but then they cleared up. By the evening of the 4th day, she started feeling fairly normal. She stated that they were mild flu symptoms. Her temperature was only 100 for about a day. She stated that that was expected. Then, she went into this flare-up about the 10th day after the vaccine. The first 3 or 4 days after the flare up began, the flare up was worsening. Then, she got it under a little bit of control, so she was not coughing all night and having to sit up as she was sleeping. Now, she was concerned about the pain and tightness in her chest and the hacky cough. She wanted to make sure it was not going into like a viral pneumonia or another thing. She did not know. She kept increasing her Advair use and was at the top of that. She was doing the duoneb which she did not usually have to do. She had not had to do that since Jan2020 when she had the 5-week flu, or it could have been COVID (they were calling it a hoax back then). She was using her duoneb 4 times a day and now she was using it to 2-3 times, but she was still getting chest tightness, hacky cough. It was kind of like nausea- it was hard to explain, it was kind of like a chest nausea, which she had also had back in Jan2020 when she had the bad flu. She also would get this laryngitis and had trouble talking. With her flare-up, her chest tightness/nausea feeling in the chest continued. Now, she was getting into laryngitis type of thing, but she could loosen that up with her duoneb but if she got to the point where she could not do that, she would definitely have to see someone right away. She clarified that when her chest got tight, the dry, hacky cough continued/increased. When she did the breathing treatment, it loosened it up for about 3-4 hours and some of the pain would go away in her chest. If she talked too much, she would begin to cough. She had had this flare up 3 times in her life, it was not very common. She was diagnosed with asthma in her 40s, and this was her 3rd time ever having anything like this. This was the first time she had experienced a flare up like this. She had had 3 episodes since she had had asthma in her 40's and all 3 bad episodes were about the same. All the episodes were related to illness, it did not just happen out of the blue. It happened with a viral respiratory thing or the flu. The adverse events did not require a visit to the emergency room or physician office. The patient stated that she would call her physician or the clinic "today or tomorrow". She had not been to a doctor since her asthma flared up. Her respiratory doctor/pulmonologist moved away, there was no respiratory doctor nearby right now. So, her general practitioner was following her because it was a mild case and she had mild asthma. If it was severe, her doctor would make her go to a specialist. Relevant tests were reported as no. The patient used to be followed with pulmonary function tests until her respiratory doctor moved away. The patient stated that she took care of her 94 year old mother several days a week and because of all of the variances coming out, she thought it was her civic duty to prevent it from spreading through the population and creating more variances which was why she received the vaccine. She stated her doses were scheduled a month apart because they expecting to get a shipment of Moderna and they did not. They had to run to Buffalo to get the Pfizer vaccine, but they left her doses scheduled a month apart because the appointments were so hard to get. Normally, it would be 3 weeks. Her card clearly said Pfizer and they told her Pfizer, and they told her the reason for it being scheduled at 4 weeks. The patient called to inquire whether asthma flare-ups had been seen in clinical trials. It was not a reported side effect from the paperwork she received. When she looked online, she could not really find anything. She was thinking of going to a clinic but was wondering if there were any reports of flare-ups with asthma with the vaccine. With regards to causality, the patient stated it was a concern because she usually did not get a flare-up unless she was sick. She stated that there were many variables, and that it was spring, and bugs were out, but she did not usually get a flare-up like this. She stated that maybe it was a challenge to her immune system, the antibodies, but she did not know. She suspected the flare-up was related to the vaccine, but she did not have any idea. She would say yes, but she had no way of knowing. The flare-up usually only appeared if she got ill or something weird happened to her. The clinical outcomes of the events flu-like symptoms, fever, achy and fatigue were recovered/resolved on 27Mar2021; sore arm and headache were recovered/resolved on 28Mar2021; asthma flare up, dry, hacky cough, pain and tightness in her chest and nausea feeling in her chest were not recovered/not resolved; she gets this laryngitis, has trouble talking and she wants to make sure its not going into like a viral pneumonia were unknown. The reporter believed there was a reasonable possibility that the events sore arm, flu-like symptoms, asthma flare-up, dry, hacky cough, pain and tightness in her chest and nausea feeling in her chest were related to BNT162B2. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the available information the events asthma flare-ups and viral pneumonia are attributed to intercurrent medical conditions, unlikely related to BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 68 | 2021-04-30 | abdominal pain upper |
stomach ache/terrible stomach ache; pain; This is a spontaneous report from a contactable consumer (...
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stomach ache/terrible stomach ache; pain; This is a spontaneous report from a contactable consumer (patient's husband). This is report 4 of 4 for the reporter's wife. A 68-year-old female patient (wife) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EN6201, Expiry Date: 30Jun2021), via an unspecified route of administration in left upper arm on 16Feb2021 at 3:45PM as single dose for COVID-19 immunization. Medical history included immune deficient and has additional issues and spinal surgical pain. Concomitant medication included oxycodone (XTAMPZA ER) at 18mg for spinal surgical pain. No additional vaccines administered on the same date of the Pfizer suspect. No prior vaccinations within 4 weeks. She does not get a lot of vaccines and this is something he has to get on her about. Reporter was concerned about his wife getting the second dose of the COVID Vaccine. She was due to get second shot on 09Mar2021. She was adamant about getting it. He was worried because she has more health issues. 24 hours later she got a terrible stomachache and pain which started in the afternoon of 18Feb2021. It lasted 3-4 days almost five days before it went away. The pain is gone now. It was low abdominal pain. It went away on 22Feb2021 (today as reported). His wife does not want to ask about her getting the 2nd dose. She would rather go in blind and not know anything. A visit to emergency room and physician's office was not required for events. The outcome of events was recovered on 22Feb2021. No follow-up attempts are possible. No further information is expected.
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| 68 | 2021-04-30 | indigestion, abdominal pain upper |
today she is off kilter again; feels a heaviness in her eyes; all that coughing like something is ir...
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today she is off kilter again; feels a heaviness in her eyes; all that coughing like something is irritating her lungs and she can't stop; it was making her lungs hypersensitive.; all of a sudden she got really really hot, she runs about 97-97.4 and she got so hot and her face got really red like she had a high fever and she was 99.2; burning in her stomach and a stomach ache; burning in her stomach and a stomach ache; never has that much energy when she was normal/had tons of energy; woke up on day 4 in the middle of the night and her lungs were pinching, pinching, pinching, like and asthma attack and she couldn't stop it and she had to get her old fashioned inhaler to stop it; tired; had weakness with climbing stairs and with exertion/ zapping her energy; 2 inches below the injection site the muscle was hard and swollen and sore; 2 inches below the injection site the muscle was hard and swollen and sore; 2 inches below the injection site the muscle was hard; This is a spontaneous report received from a contactable consumer (patient). A 68-year-old female patient received the first dose of BNT162B2 (PFIZER- BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 07Apr2021 14:40 (lot number: EW0150) at age of 68 years as single dose for COVID-19 immunisation. Medical history included low vitamin D, lungs were working at 75% the capacity of an 84 year old and not 68 year old and asthma attacks. Concomitant medications included vitamin D2 and D3 and regular vitamins for low vitamin D, had been taking that for 6-7 weeks, tiotropium bromide (SPIRIVA RESPIMAT) 2.5mcg takes 2 inhales a day in the morning and salbutamol sulfate (PROAIR) 2 puffs and a special medication because her lungs were working at 75% the capacity of an 84 year old and not 68 year old and put her on an asthma medication to open her lungs. Patient got a flu shot every year and got it in Jan2021 and nothing. Patient stated that her symptoms were mild. Patient stated on day 1 after she got the shot she had nothing, that was 07Apr2021. Stated the next day (08Apr2021) she did not have injection site soreness but 2 inches below the injection site the muscle was hard and swollen and sore and remained that way for days 2, 3 and about day 4 it started to recede and day 7 it was tender. Stated it was one muscle and it was below the injection site, not at the injection site. Stated it was a lifting muscle, if she lifted her arm up it could only go so far and she would feel it and drop her arm down. Stated she got the injection in her left arm as she used it the least. Stated on days 2 (09Apr2021), 3 and 4 she had weakness with climbing stairs and with exertion, she could do it but she would notice it was more of a struggle. Stated that today she was off kilter again. Patient relayed that she looked all over online to see if she was sick with something. Stated she was tired on days 3 (10Apr2021) and 4 and that on days 5 (12Apr2021) and 6 she had tons of energy and she worked from dawn to dusk waxing floors and never has that much energy when she was normal. Stated that all of a sudden on day 5 and 6 she was perfect and then toward the evening of day 6 she thought it was her as she had to go to the Secretary of States and stand in line to renew her license and she did well and got home and started feeling tired. States she woke up last night of day 6 (13Apr2021) with a burning in her stomach and a stomach ache and it woke her and made her feel like she had food poisoning or something like that and nothing happened and she took 2 Tums and it kind of settled that down. Stated on day 7 (14Apr2021) she woke up and the stomach part was gone and all of a sudden she got really really hot, she runs about 97-97.4 and she got so hot and her face got really red like she had a high fever and she was 99.2, which is not much for most people but she feels and she took Motrin and after that she still feels a heaviness in her eyes and her temperature is 98.6 and she is normally in the 97's and was running a 2 degree fever and now maybe a 1 degree fever and she felt it in her eyes and didn't feel sick. Stated she felt fatigued like she want to take a nap but didn't feel ill. Stated whatever was going on was zapping her energy. Stated she woke up on day 4 (11Apr2021) in the middle of the night and her lungs were pinching, pinching, pinching, like an asthma attack and she couldn't stop it and she had to get her old fashioned inhaler to stop it. Stated this hadn't happened and she had been taking the special medication for 3 weeks now and it was very rare for her to get those attacks and this was worse than any. Patient relayed that today all day even with the special medication to open her lungs she can feel in her lungs that they were, she can't explain it, like they are gripping and releasing and gripping and releasing a little but. Stated she knew she was having some kind of asthma thing going on, it was not making her cough it was making her lungs hypersensitive. Stated she was expecting everything and she did read and nobody had symptoms that last more than 7 days and she was expecting them to be gone tomorrow, or she hopeed anyways. Stated the last 10 days had been easy-peasy and all of a sudden she was waking with all that coughing like something was irritating her lungs and she can't stop. Patient provided that it woke her husband up with her coughing for half an hour. States this lasted half an hour and was more than normal and something really irritated her lungs, shouldn't have happened as she is on the other thing every day and has not had an attack with that. Patient stated her provider didn't know as it was so relatively minor and was unusual but minor and she did not feel like it was life threatening. Stated her brother had Covid and she did not feel like she was trying to breathe and couldn't, or suffocating and dying. She did not feel that. The air irritated to even breathe and made her cough and couldn't stop and that was the first time she had to use an inhaler on top of on inhaler and something made her lungs respond to nothing there. Stated it may be her immune system thinking something was there, the headless thing in her lungs. Patient stated she thought she was over it and then got the fever not understanding if the fever was Covid related and she stayed at home and didn't go out until yesterday it was the 1st day out since Thursday and how could she have caught anything if she wasn't near anybody. Stated these were just thoughts in her head. Outcome of events was unknown.; Sender's Comments: The reported event of asthma aggravated was assessed as possibly related based on temporal association. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for AE. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.
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| 68 | 2021-05-04 | nausea |
Felt lightheaded/Dizziness; tired; a bit nauseous; felt vertigo when moved my head, doctor believes ...
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Felt lightheaded/Dizziness; tired; a bit nauseous; felt vertigo when moved my head, doctor believes it's cervical vertigo and linked to my neck; This is a spontaneous report from a contactable consumer (patient, self-reported). A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, in right arm, on 29Jan2021 at 09:30 PM, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included lymphoma (finished treatment last year. Currently cancer free with white blood cells recovering and close to normal range), depression, anxiety and vertigo. The patient had known allergies with Penicillin. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient did not receive any other vaccine in four weeks. The patient received other medications in two weeks which included Alprazolam (XANAX), Ibuprofen, and Paxil. The patient reported that on 29Jan2021 at 10:00 PM, she felt lightheaded after initially being vaccinated. She felt funny and tired and a bit nauseous yesterday. She woke up this morning and felt vertigo and dizziness if she moved her head at all. She had a history of vertigo, but it didn't usually come on unless she had missed a dose of medication or had done something to hurt her neck as her doctor believes it was cervical vertigo and linked to her neck. The patient did not receive any treatment for the events. Outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 68 | 2021-05-07 | nausea |
she feels like she has Covid; feeling chest pain/her chest is sore; headache/her head just starting ...
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she feels like she has Covid; feeling chest pain/her chest is sore; headache/her head just starting hurting; she is scared; She used to weight 143 pounds 9 months ago, she states she is swelling up.; overall body aches; cramping; eyes had swollen; fever of 101.9°F/temperature like 101.9 degrees, a fever; chills; nausea; wiping would be pink/She also states that she when she went to the bathroom, she wiped pink and it worsened and turned darker.; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received bnt162b2 (BNT162B2), dose 1, via an unspecified route of administration, administered in Arm Right on 12Apr2021 11:00 (Lot Number: EP7534; Expiration Date: 31Jul2021) as SINGLE DOSE (at the age of 68 years old) for covid-19 immunisation. Medical history included she is on the borderline of Chronic obstructive pulmonary disease (COPD). She was taking breathing medicine, but has been taken off of it, she is doing so well; osteoporosis; osteoarthritis; osteopenia. Concomitant medication included hydrocodone (HYDROCODONE) taken for osteoporosis, osteoarthritis, osteopenia, start and stop date were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On unspecified date the patient experienced feeling chest pain/her chest is sore, headache/her head just starting hurting, she is scared, she used to weight 143 pounds 9 months ago, she states she is swelling up and overall body aches. On 14 Apr2021, she experienced wiping would be pink/She also states that she when she went to the bathroom, she wiped pink and it worsened and turned darker. She wiped this morning, and she thinks it stopped. She felt cramping. It started light pink, then a couple days ago it was darker. She was a walk in patient at the clinic to be checked out. She lives alone, has no companion for a sex life, she had no new medications. She went to her physician yesterday 22Apr2021, and had a pap smear and blood draws. Her MD told her to take Airborne around the time of the second vaccine. On 16Apr2021 she experienced nausea. On 22Apr2021 the patient experienced eyes had swollen, fever of 101.9°F/temperature like 101.9 degrees, a fever, chills. On 23Apr2021 the patient experienced cramping.The headache has been on and off all weekend. She felt she was dying. The worst yesterday. She read all the Covid symptoms and all her symptoms point toward Covid. She feels like she has Covid from unknown date.She has chest pain and tries to ignore it, but she can't. She has to go get her pain pills because her head just starting hurting.The patient underwent lab tests and procedures which included body temperature: 101.9 degrees fahrenheit on 22Apr2021, blood test: unknown results on 22Apr2021, pap smear: unknown results on 22Apr2021, weight: 143 lbs on 9 months ago. Therapeutic measures were taken as a result of overall body aches. She took gas pain pills, allergy relief pain pills because her whole body hurt. She has been applying warm towels to her eyes to help with swelling. Outcome of fever of 101.9°F/temperature like 101.9 degrees, a fever, chills was recovered on 23Apr2021. Outcome of eyes had swollen, headache/her head just starting hurting, nausea, wiping would be pink/She also states that she when she went to the bathroom, she wiped pink and it worsened and turned darker was recovering. Outcome of feeling chest pain/her chest is sore was not recovered. Outcome of she feels like she has Covid, she is scared, cramping, he used to weight 143 pounds 9 months ago, she states she is swelling up, overall body aches were unknown.
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| 69 | 2021-01-05 | abdominal pain upper, diarrhea |
Soreness in the arm started later on the same day (late evening on 12-30-20). Woke up at 5:00 am the...
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Soreness in the arm started later on the same day (late evening on 12-30-20). Woke up at 5:00 am the next morning (12-31-20)with severe chills, headache and dizziness. Felt as if I had covid all over again (was diagnosed with covid on October 12, 2020). My whole body ached and I was extremely fatigued. All I wanted to do was sleep and I also started a slight cough. Later on in the afternoon I started to sweat profusely. I had chills/sweats all through the afternoon and into the evening. I did not even get out out bed until the next afternoon (1-1-21). For 2 days afterwards I had chills/sweats and on 1-2-21 I had terrible stomach cramps and diarrhea.
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| 69 | 2021-01-08 | nausea | Nausea Extreme tiredness Body Ache Chills Fever. 100f |
| 69 | 2021-01-10 | decreased appetite |
Fever ranging from 100.2 degrees F to 102.2 degrees F for 36 hours, moderate relief with Tylenol. ...
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Fever ranging from 100.2 degrees F to 102.2 degrees F for 36 hours, moderate relief with Tylenol. Joint pain for 72 hours with mild relief with Tylenol. Loss of appetite for 24 hours. Left deep armpit pain for 4 days, just subsiding but still evident. Left deltoid injection site warm and red with redness tripling in size over 3 days (covered entire deltoid region.) Site remains warm and red since initial injection but seems to be improving today (day 4 post vaccine)
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| 69 | 2021-01-12 | nausea, vomiting |
Employee received Pfizer COVID19 vaccine dose 1. After 5 mins, complained of N/V , vertigo, chest ti...
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Employee received Pfizer COVID19 vaccine dose 1. After 5 mins, complained of N/V , vertigo, chest tightness.
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| 69 | 2021-01-12 | vomiting, nausea | Nausea/vomiting, chest tightness |
| 69 | 2021-01-14 | diarrhea |
experiencing pain in her back where kidneys; fatigued/extreme fatigue; dry cough; diarrhea; aches/pa...
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experiencing pain in her back where kidneys; fatigued/extreme fatigue; dry cough; diarrhea; aches/pains/aches and pains around her body; severe pain in injection arm; injection site very painful; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 06Jan2021 at single dose for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported. She reported that the evening of her first dose, she experienced severe pain in injection arm on 06Jan2021. She stated that night injection site very painful. She had to take Tylenol Extra Strength overnight. She stated that she woke up and she was fine. On 09Jan2021, she reported feeling fatigued, dry cough, extreme fatigue, diarrhea, aches/pains, and aches and pains around her body, but no fever. She woke up this morning on 11Jan2021, experiencing pain in her back where kidneys, still fatigued but no fever. She has taken the Covid test and does not have the results. She wanted to know if these are side effects of the vaccine or is this potentially the Covid virus. The events were assessed non-serious. The outcome of severe pain in injection arm, injection site very painful was recovered, of fatigued was not recovered, of other events were unknown. Information on the lot/batch number has been requested.
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| 69 | 2021-01-14 | nausea |
Nauseated and lightheaded, near syncope. Lasted about 20 minutes, took vitals, rested, and recovere...
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Nauseated and lightheaded, near syncope. Lasted about 20 minutes, took vitals, rested, and recovered.
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| 69 | 2021-01-15 | vomiting | Vomiting |
| 69 | 2021-01-16 | nausea | First day : Pain the arm and chills 2nd day : Nausea |
| 69 | 2021-01-18 | nausea |
Systemic: Nausea-Mild, Systemic: Eyes tearing (patient did also state she had this for a few days pr...
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Systemic: Nausea-Mild, Systemic: Eyes tearing (patient did also state she had this for a few days prior as well, just worse after receiving vaccine)
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| 69 | 2021-01-19 | diarrhea | severe diarrea |
| 69 | 2021-01-19 | vomiting |
At 1332, she called into the office to let us know that she was not feeling well after her vaccine. ...
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At 1332, she called into the office to let us know that she was not feeling well after her vaccine. 1331 2 RN's got to her vehicle to assess her. She stated she was feeling "not right", complained of her left arm hurting, a headache, and right ear pressure. Vital signs at 1339 showed a BP of 138/76 done by manual cuff, a pulse was taken radially and was 78 bpm, with a regular rate and rhythm by palpation, respirations were 26 breaths per minute, and her O2 saturation was 99%. 1342 she had episodes of emesis out the side of her vehicle multiple times. 1344 EMS was called. 1347 50mg of IM Benadryl was administered into her right deltoid. EMS arrived at 1349 and care was transferred over at that time. Her husband took her car keys and was driving separate to Emergency Department.
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| 69 | 2021-01-20 | nausea |
anterior cervical fusion; Headache; tested positive for COVID-19; tested positive for COVID-19; musc...
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anterior cervical fusion; Headache; tested positive for COVID-19; tested positive for COVID-19; muscle aches; Loss of taste; Loss of smell; Nausea; sore arm; Tiredness; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot EJ1686, intramuscular in right deltoid on 03Jan2021 11:00 at single dose for covid-19 immunisation. Medical history included ongoing essential tremor started in her 50's. The patient's concomitant medications were not reported. The patient did not receive other vaccine within four weeks. On 03Jan2021 the patient experienced sore arm and tiredness. On 07Jan2021 the patient experienced anterior cervical fusion and was hospitalized from 07Jan2021 to 09Jan2021. On 08Jan2021 the patient experienced nausea. On 09Jan2021 the patient experienced muscle aches, loss of taste and loss of smell. On unknown date the patient experienced headache. The patient was tested positive to COVID-19 on 11Jan2021. The patient did not visit Physician Office or Emergency Room. Laboratory data included COVID-19 Rapid Test positive on 11Jan2021. The outcome of the events tested positive for COVID-19, and anterior cervical fusion was unknown. The outcome of the events sore arm, tiredness, nausea, muscle aches, headache was resolving. The outcome of the events loss of taste, loss of smell was not resolved.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 03Jan2021, and COVID-19 test positive on 11Jan2021. No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID likely represents a pre-existing infection prior to vaccine use. This 69-year-old female had medical history of ongoing essential tremor started in her 50's. The reported anterior cervical fusion was most likely due to concurrent disease, and unlikely causally related to the vaccine of BNT162B2. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 69 | 2021-01-21 | vomiting, difficulty swallowing |
While half way through eating a Lean Cuisine Butternut Squash Ravioli dinner I suddenly couldn't swa...
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While half way through eating a Lean Cuisine Butternut Squash Ravioli dinner I suddenly couldn't swallow. I coughed and threw up what I had eaten. My throat was extremely itchy and my head became very congested. I have never had a food allergy before but after searching that I found the symptoms to be similar. My face was not particularly swollen but I was unable to eat anymore and my throat continued to be very itchy on the right side. I eat mostly on that side due to a dental problem on the left side. I took an antihistamine, gargled with mouth wash, used a Netti Pot and sucked a cough drop. The itchiness was reduced by the next morning and gone by that afternoon.
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| 69 | 2021-01-24 | nausea, vomiting |
At 6:00 AM, suddenly had severe pain in left side of neck, headache, extreme vertigo, chills and nau...
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At 6:00 AM, suddenly had severe pain in left side of neck, headache, extreme vertigo, chills and nausea. Multiple sessions of vomiting. Saw rings of colored lights and squigly lines. Took Tylenol and Benadryl per PCP by phone. Dizziness and chills went away in about 12 hours. Still saw squigly lines at night. Much better the next day but queasy for another 24 hours.
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| 69 | 2021-01-25 | nausea | Within 15-minutes of vaccination, the patient complained of nausea and lightheadedness. |
| 69 | 2021-01-25 | nausea |
sore throat, stiff neck, chills, body aches, nausea, headache (day 2 still have headache), extreme f...
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sore throat, stiff neck, chills, body aches, nausea, headache (day 2 still have headache), extreme fatigue, swollen lymph nodes, increased blood pressure, night sweats
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| 69 | 2021-01-25 | vomiting, nausea |
2:00-chills all the way down my right side (2pm-7am Started throwing up...12 hours of nausea and vom...
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2:00-chills all the way down my right side (2pm-7am Started throwing up...12 hours of nausea and vomiting 3:00-extreme headache (took aspirin for pain) -lower back hurt -pain in right shoulder, elbow, wrist -couldn?t lay on right side (bruising at site but no swell -couldn?t move without vomiting -woke up at midnight completely wet with sweat and sweating continuing even today Tuesday -weakness all over (felt like I had had the FLU) ? I knew there was potential for side effects before taking the vaccine...I was totally unprepared for so many symptoms and how intense they were and what little I could do to relieve any of them. Never had fever that I am aware of. Today I?m weak and sweating is unreal. ?? Should I prepare/expect my second dose around Feb. 14 to have the same effect on me.? Not looking forward to that. I was almost ready to go to the ER I was getting so dehydrated and weak.
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| 69 | 2021-01-26 | diarrhea, vomiting, decreased appetite, nausea |
HPI: 69 y/o woman with minimal PMH of hysterectomy and cystic mass resection in 2016. She presented ...
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HPI: 69 y/o woman with minimal PMH of hysterectomy and cystic mass resection in 2016. She presented with c/o fatigue, fevers, shaking chills, SOB/cough, anorexia, N/V/D for the past 6 days (GI symptoms started 2 days ago). Husband reports she has also had periodic confusion during this time. She received her second COVID vaccine 7 days ago and symptoms started the following day.
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| 69 | 2021-01-28 | diarrhea | Diarrhea severe on day 5. |
| 69 | 2021-01-28 | nausea | Nasuea, Chills, Joint aches |
| 69 | 2021-01-28 | nausea |
Nauseous; Lightheadedness; very Emotional; Crying; This is a spontaneous report from a contactable c...
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Nauseous; Lightheadedness; very Emotional; Crying; This is a spontaneous report from a contactable consumer. A 69-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 08:00 at single dose (Lot number= EL3246, Vaccine location=Left arm) for covid-19 immunisation. Medical history included low thyroid, high blood pressure, reflux disease, anxiety, depression, Allergies: sulfa "caflex". Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medication included calcium citrate, venlafaxine hcl, pantoprazole, nortriptyline, levothyroxine sodium (SYNTHROID), amlodipine, estrogens conjugated (PREMARIN), paracetamol (TYLENOL). No other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nauseous, lightheadedness, very emotional, crying on 16Jan2021 09:00. No treatment received for the events. Events result in clinic visit. Outcome of events was unknown. Since the vaccination, the patient had not been tested for COVID-19.
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| 69 | 2021-01-29 | abdominal pain | Mild pain, headache, chills, and abdominal pain. Mild-moderate fever 102.3. Moderate fatigue. |
| 69 | 2021-01-29 | nausea | sore arm, headache that night, nausea the following day. |
| 69 | 2021-01-30 | decreased appetite |
Chills for about 3 hours, slight fever, then the fever broke. Also had headache, brain fog, some fa...
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Chills for about 3 hours, slight fever, then the fever broke. Also had headache, brain fog, some fatigue. Slept 9 hours and next day felt tired with low appetite but fever, chills were gone. By 48 hours, all symptoms had passed and I felt normal.
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| 69 | 2021-01-30 | diarrhea | Flu symptoms: chills, diarrhea , headache, sore left arm (injection site) |
| 69 | 2021-01-30 | nausea |
Adrenal crisis treated with 30mg prednisone, 50mg hydrocortisone x2 6 hours apart, caffeine, Motrin,...
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Adrenal crisis treated with 30mg prednisone, 50mg hydrocortisone x2 6 hours apart, caffeine, Motrin, Zofran, chicken broth for electolytes> Signs included hypotension, nausea, headache, weakness, I am a retired doctor married to an Endocrinologist and living to take care of my 2yo grandson for my daughter who is a resident in PEDS , I and my family are very familiar with managing my illness, which infrequently presents with crisis and I very rarely must be hospitalized .
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| 69 | 2021-01-31 | nausea |
feeling ill; headache; fever; tired; a slight cough; Nausea; Just an overall feeling of being sick n...
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feeling ill; headache; fever; tired; a slight cough; Nausea; Just an overall feeling of being sick not feeling well; Pain in my back that radiated between my shoulder blades and down and to my lower back like crossed my kidneys; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3248), via an unspecified route of administration at Right arm on 12Jan2021 10:00 at SINGLE DOSE for COVID-19 vaccination. Medical history included diabetic, high blood pressure and possible Atrial fibrillation (AF). Concomitant medications in two weeks included lisinopril, atorvastatin, aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]). The patient started feeling ill the day after the shot, she had a headache, fever, tired, a slight cough, Nausea, Pain in her back that radiated between her shoulder blades and down and to her lower back like crossed her kidneys. Just an overall feeling of being sick not feeling well. She was questioning whether she may have been exposed to Covid and she was experiencing Covid symptoms. The events started from 13Jan2021 01:00 AM and not recovered at the time of reporting. No treatment received, no covid prior vaccination, no covid tested post vaccination, no known allergies.
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| 69 | 2021-02-01 | nausea |
I give the girl in front of me the Covid vaccine way high on her arm. I told MA do not give my shot ...
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I give the girl in front of me the Covid vaccine way high on her arm. I told MA do not give my shot that high up. She said in a snide voice it?s still the deltoid and she shot my bursa. The evening of the shot I started having severe arm pain and nausea. The next morning I had right scapula rib pain it was hard to breathe my arm hurt very bad I can hardly lift it I went to work. When I got to work I couldn?t function I was so nauseated with the pain I went home that day and I?ve missed three days total from that event of wrong injection site. The pain has gotten worse I can?t lift my arm left right upper down without pain and it?s going into my neck and down to my elbow now I went to the occupational medical doctor. I told him what happened and he said she gave me the shot am I supraspinatus Bursa and I have an injury to my bursa. I came back for a second visit the next week and he said I have bursitis from that now I can?t raise and use my arm that well at all and I have severe pain 24 seven still and he sent me to a physical therapist starting today 2 to 21. It has gotten worse and my shoulder has locked up three times. I still have ongoing pain 24 seven and I want to report a complaint against the girl who gave my shot I thought she was an LPN but she is a MA. We both work at healthcare clinic. I am a 26 year RN and she did not listen to me and she stuck me anyway against my will.
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| 69 | 2021-02-02 | nausea |
About 40 minutes after the injection I became very nauseous while driving home and it has persisted ...
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About 40 minutes after the injection I became very nauseous while driving home and it has persisted in a lesser way since then.
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| 69 | 2021-02-02 | nausea |
At injection site in right arm, bruising developed, and redness appeared approximately 3 inches belo...
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At injection site in right arm, bruising developed, and redness appeared approximately 3 inches below injection site. It was a large red area about size of a small apple. The raised area was red and warm. Fever 102.9 Nausea Dizziness Bladder control dysfunction - once Persistent headache.
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| 69 | 2021-02-03 | constipation | Constipation began early evening; Chills and fever began around 8 p.m. same day as the inoculation. |
| 69 | 2021-02-03 | diarrhea |
severe diarrhea; This is a spontaneous report from a contactable consumer (patient). A 69-year-old n...
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severe diarrhea; This is a spontaneous report from a contactable consumer (patient). A 69-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration on 19Jan2021 12:45 at a single dose for covid-19 immunization. Medical history included RA (rheumatoid arthritis), cardiomyopathy, intervertebral disc degeneration, and known allergies to wheat and dairy. The patient was not diagnosed with covid prior vaccination. Concomitant medications included unspecified medication. The patient has not had other vaccine in the last 4 weeks. The patient previously took clindamycin but had allergies. The patient had severe diarrhea on 20Jan2021 12:00 PM. No treatment was received. The patient was not covid tested post vaccination. The outcome of the event was not recovered. The following information on the batch/lot number has been requested.
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| 69 | 2021-02-03 | nausea |
INJECTION SITE PAIN, TIREDNESS, HEADACHE, MUSCLE PAIN, CHILLS, FEVER, INJECTION SITE SWELLING, INJEC...
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INJECTION SITE PAIN, TIREDNESS, HEADACHE, MUSCLE PAIN, CHILLS, FEVER, INJECTION SITE SWELLING, INJECTION SITE REDNESS, NAUSEA, FEELING UNWELL FLU LIKE SYMPTOMS
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| 69 | 2021-02-03 | nausea |
Client felt nauseous and had palpitation. Paramedics assess client on site. Client was released at...
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Client felt nauseous and had palpitation. Paramedics assess client on site. Client was released at 10.
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| 69 | 2021-02-03 | nausea |
Within 15-minutes of vaccination, the patient became nauseous, clammy, dizzy, and had a near syncopa...
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Within 15-minutes of vaccination, the patient became nauseous, clammy, dizzy, and had a near syncopal episode. EMS reported the patient's blood pressure being 70/40 mmHg. EMS administered IV saline and transported patient to emergency department. In the emergency department, patient stabilized and was discharged shortly after.
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| 69 | 2021-02-03 | nausea |
Within 15-minutes of vaccination, the patient reported nausea and felt that their heart was racing. ...
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Within 15-minutes of vaccination, the patient reported nausea and felt that their heart was racing. EMS managed patient's condition on-site.
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| 69 | 2021-02-03 | vomiting |
Temperature of 101.5 -- chills - headaches - shoulder & neck pain - muscle pain - fatigue - vomiting...
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Temperature of 101.5 -- chills - headaches - shoulder & neck pain - muscle pain - fatigue - vomiting Feeling better on day 2
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| 69 | 2021-02-04 | nausea |
extremely nauseated; my eyes kind of crossed; Well after the shot I could barely even walk from the ...
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extremely nauseated; my eyes kind of crossed; Well after the shot I could barely even walk from the first tent to the second tent; UTI; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reported stated she receive the first dose of the COVID-19 vaccine on Wednesday 20Jan2021 and she had a "strange" reaction on 20Jan2021. Specifically, she states, "as soon as she pushed it in, I became extremely nauseated, my eyes kind of crossed and I had to sit in my car for 4 hours afterwards because I couldn't drive. They had 2 tents set up. Tent 2 was for people who had previous reactions or allergies and tent 1 was for people who had no reactions. Well after the shot I could barely even walk from the first tent to the second tent I stayed there for 45 minutes and then I could barely even walk to my car." Caller wants to know if she should get the second dose of the vaccine. She was started on the antibiotic sulfamethoxazole;trimethoprim (BACTRIM) on 22Jan2021 for a UTI which started after receiving first dose of COVID-19 vaccine in Jan2021. She would like to know if it is okay to use this medication since she just received the vaccine. She reported that she submitted her urinalysis the same day that she received the vaccine on 20Jan2021. The patient underwent lab tests and procedures which included urinalysis: with unknown results on 20Jan2021. Therapeutic measures were taken as a result of UTI. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 69 | 2021-02-04 | nausea | Today I have muscle and joint pain, a headache and nausea |
| 69 | 2021-02-04 | nausea | slight headache, slight, nausea, chilling |
| 69 | 2021-02-04 | vomiting, diarrhea | Fever of 103.7, vomiting, diarrhea, myalgia, shaking chills, called 911 |
| 69 | 2021-02-07 | decreased appetite, vomiting, nausea, diarrhea, abdominal pain upper, abdominal distension |
Fever; chills; fatigue; nauseous; throwing up; Diarrhea; severe stomach pain; stomach pain with swel...
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Fever; chills; fatigue; nauseous; throwing up; Diarrhea; severe stomach pain; stomach pain with swelling and feeling bloated; no appetite; This is a spontaneous report from a contactable healthcare professional (HCP) reporting for herself. A 69-year-old female patient received first single dose of BNT162B2 (Solution for injection, lot number: EJ 1686, exp date not reported), via an unspecified route of administration (left arm) on 14Jan2021 13:45 for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Nursing Home/Senior Living Facility. Medical history included allergies to seafood, latex, and steroids. The patient had COVID prior to vaccination (date/s unknown). The patient had no other relevant history. The patient was not pregnant at time of vaccination and was not pregnant at the time of reporting. Concomitant medications/other medications the patient received within 2 weeks of vaccination included amoxicillin, calcium, cinnamomum verum (CINNAMON), chromium, and multivitamin (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took ephedrine and codeine and experienced allergy to both. On 15Jan2021 13:30, the patient experienced fever, chills, fatigue, nauseous, throwing up, diarrhea, severe stomach pain with swelling and feeling bloated; and no appetite. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The events were considered as non-serious by the reporter. Treatment for the events included ondansetron (ZOFRAN), dexamethasone 0.5 (unit not reported), and doxycycline 20 mg. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events at the time of reporting.
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| 69 | 2021-02-07 | vomiting |
1:00 received Vaccine 4:00 ate meal 7:00 vomited 3 times in succession felt be...
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1:00 received Vaccine 4:00 ate meal 7:00 vomited 3 times in succession felt better with NO other symptoms Slept for 10 hours
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| 69 | 2021-02-08 | nausea | Chills/Shaking, 102 fever, swollen lymph nodes under chin, nausea, tiredness |
| 69 | 2021-02-09 | nausea |
Pain through back across both arms and neck.; A headache that feels like my heads going to explode.;...
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Pain through back across both arms and neck.; A headache that feels like my heads going to explode.; swell up like a balloon; Nauseated; Chills; fever; Pain on both my legs cannot walk; Pain through back across both arms and neck. Cannot lift my arms; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on the right arm on 20Jan2021 16:00 at single dose for covid-19 immunization. Medical history included atrial fibrillation from an unknown date and unknown if ongoing , hypersensitivity (Known allergies: Yes) from an unknown date and unknown if ongoing, covid-19 (if covid prior vaccination: Yes) from an unknown date and unknown if ongoing. Concomitant medications included unspecified medications. The patient experienced pain through back across both arms and neck, the patient cannot lift their arms. The patient also experienced pain on both their legs cannot walk, a headache that feels like their heads going to explode, nauseated all the time, swell up like a balloon, chills and fever. It was reported that the events occurred on 21Jan2021. Therapeutic measures were taken as a result of pain through back across both arms and neck. The patient did not recover from the events. Information on the lot/batch number has been requested.
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| 69 | 2021-02-10 | diarrhea |
deyhydration; sick; sinus tachycardia; diarrhea; Fever over 102 degrees Fahrenheit; chills; headache...
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deyhydration; sick; sinus tachycardia; diarrhea; Fever over 102 degrees Fahrenheit; chills; headache; body aches; fatigue; dizziness; Pfizer COVID-19 Vaccine on 12Jan2021 with immunosuppressant mesalamine; Pfizer COVID-19 Vaccine on 12Jan2021 with immunosuppressant mesalamine; will fall asleep through the day for 3-4 hours at a time and she does not even nap usually; Muscle pain; Neck ache; Backache; Problems with walking; problems with balance; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL3246), via an unspecified route of administration on the left arm on 12Jan2021 14:30 at a single dose for covid-19 immunization. Vaccine was not administered in a military facility. Medical history included ongoing ulcerative colitis, ongoing high cholesterol, ongoing high blood pressure, celiac disease from 2005 (this has been tested too many times to count and it has been negative since after initial diagnosis 2005), arthritis (all her life) ongoing, hip replacement surgeries first done in 2005; repair of same hip in 2015; other hip in 2017. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccines include Pneumonia Vaccine, Shingles Vaccine and Flu vaccines; all on an unspecified date for immunization. She never had adverse events with those. Ongoing concomitant medications included rosuvastatin (5 mg tablet) for high cholesterol, mesalamine (400 mg capsule) for ulcerative colitis and lisinopril from 2018 for high blood pressure. According to the patient, she knows that mesalamine is an immunosuppressant and anti-inflammatory to keep inflammation in the colon down. This consumer was administered her first dose of Pfizer COVID-19 Vaccine on 12Jan2021 14:30 with immunosuppressant mesalamine. The night of 14Jan2021 patient had headache, chills, body aches, diarrhea, fatigue, fever and dizziness like Covid 19 symptoms. She went to the ER during the past 11 days for IV fluids due to deyhydration from the diarrhea. Today, 25Jan2021 is the first day she has been out of the house, except to go to the ER, since she received her 1st vaccine dose. On Jan2021 muscle pain, neck ache, backache, problems with balance and problems with walking. Events probably started with intense diarrhea starting 14Jan2021; then Fever over 102 degrees Fahrenheit and chills 14Jan2021; Specific onset dates and onset times unknown otherwise other than between 14Jan2021 and 16Jan2021 onset dates. It was a rolling week of agony after that with one adverse event after another until she ended up in the emergency room on 16Jan2021 because she was so dehydrated and was really sick. She was not admitted to the hospital related to any of these events; but while in the emergency room she was given intravenous fluids; a chest x-ray; blood work; after maybe 5-6 hours she was sent home; she was also given a COVID test which was negative; and then 2 days later took another COVID test which was also negative. Both COVID tests were Rapid Tests: on 16Jan2021 and 18Jan2021. On the Chest xray they suggested she had some sinus tachycardia which is just a rapid heartbeat and not surprising; nothing else showed up on Chest x-ray; as far as anything else testing/results wise there was only some facetious blood work which they just said to follow-up with her PCP regarding but nothing really out of the ordinary. She can finally out of bed on a regular basis for a couple of hours daily; she is still very fatigued; she has no muscle pain, neck aches or body aches at this time; she does not have the strength she should have; is no longer experiencing headaches or fever; but is extremely tired. She will fall asleep through the day for 3-4 hours at a time and she does not even nap usually (Jan2021). She has not driven yet but assumes probably once she is a little stronger she will be able to drive again. She did not have upper respiratory, chest or cough issues. The outcome of the events fever, headache, body ache, muscle pain, neck ache was recovered on Jan2021; fatigue was not recovered. The outcome for the other events was unknown.
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| 69 | 2021-02-10 | nausea | Slight fever nausea headache fatigue |
| 69 | 2021-02-10 | vomiting, nausea |
Tested positive for COVID; Tested positive for COVID; Lost taste and smell; Lost taste and smell; co...
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Tested positive for COVID; Tested positive for COVID; Lost taste and smell; Lost taste and smell; cold like symptoms; Fever; chills; nausea; vomiting; felt cold; runny nose; This is a spontaneous report from a contactable consumer (patient). This 69-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) via intramuscularly at left arm on 07Jan2021 at single dose for prevention. Medical history included allergic to Penicillin, quite a bit of discomfort with two shingles shots, exposed to COVID-19. Concomitant medications were none. The patient experienced cold like symptoms, Fever, chills, nausea, vomiting, felt cold, runny nose, all on 17Jan2021 10:00; lost taste and smell on 21Jan2021; tested positive for COVID on 22Jan2021 10:20. The patient received the first inoculation 07Jan2021, she had symptoms. The patient was tested for COVID on 22Jan2021 and both tested positive. The patient was scheduled to have their second dose on 28Jan2021, and she wanted to know if she should get it or not. She did not feel it was a result of the vaccination. She felt it was because she got exposed to COVID-19. Her symptoms were more severe on that one day. She felt like she was getting a cold that day. She was a compassionate care giver for her mother and wanted to get tested before they went to see her in a facility. She was surprised when she got a positive result. She still had a cough, runny nose and cold like symptoms. Her loss of taste and smell started about 4-5 days ago. Outcome of the event tested positive for COVID was unknown, of the event Lost taste and smell was not recovered, of other events was recovering.
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| 69 | 2021-02-11 | nausea |
Symptoms include rapid heart rate, elevated blood pressure, nausea, and palpitations lasting for app...
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Symptoms include rapid heart rate, elevated blood pressure, nausea, and palpitations lasting for approximately 4 hours. Patient has a history of heart disease so the vaccine may have triggered an existing condition.
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| 69 | 2021-02-11 | nausea |
Patient sitting in chair, alert and oriented x 3, skin color was ashen. Patient felt strange over he...
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Patient sitting in chair, alert and oriented x 3, skin color was ashen. Patient felt strange over her chest, light headed, patient said she feels like she was going to pass out immediately after vaccine administration. VS 100/60 mmHg, pulse 64, RR 22. Patient complaints of headache, nausea and skin clamy and warm. Site manager made aware, o2 @ 2 L via nasal cannula administered. EMS transport to hospital. Daughter was made aware via VM, unable to reach 3x attempts.
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| 69 | 2021-02-14 | abdominal discomfort, burping |
The evening of Feb 4th she started feeling tired. Feb 7th still tired, started feeling anxious, hear...
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The evening of Feb 4th she started feeling tired. Feb 7th still tired, started feeling anxious, heart was beating harder and faster, stomach felt upset, she was burping a lot Feb 8th went to primary care doctor. BP was 175/90. She felt dizzy and lightheaded, ringing in ears was louder than usual She gave another BP med to take, but she didn't take it. Instead took an extra of hr own propranolol. Yesterday was the first day the sxs were better. Other than taking the extra propranolol on Feb 8th, she just rested 2/11/21 is the first day the tiredness has let up
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| 69 | 2021-02-14 | diarrhea |
Triggered an Auto immune flair up response I get with Sjogrens syndrome..Generalize muscle and joint...
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Triggered an Auto immune flair up response I get with Sjogrens syndrome..Generalize muscle and joint pain, Extremely dry eyes, mouth. Fatigue. Dizziness. Diarrhea. from 1/29/2021 to 1/31/3021
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| 69 | 2021-02-14 | nausea | Sluggish quizzing weakness slight temp |
| 69 | 2021-02-15 | decreased appetite |
Fatigue, chills, headache, temperature (100.5), loss of appetite, restless sleep, swollen arm at in...
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Fatigue, chills, headache, temperature (100.5), loss of appetite, restless sleep, swollen arm at injection site, red injection site that is about 4? long, itching injection site. Injection site still red, swollen and itching. Taking Tylenol and using topical Benadryl for itching. Appetite returned on 2nd day. Fever, fatigue and chills lasted 1 day.
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| 69 | 2021-02-15 | nausea, diarrhea |
HEADACHE, NAUSEA, JOINT INFLAMMATION, EXCESSIVE NASAL MUCOUS DRAINAGE, DISORIENTATION, DIZZINESS, HY...
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HEADACHE, NAUSEA, JOINT INFLAMMATION, EXCESSIVE NASAL MUCOUS DRAINAGE, DISORIENTATION, DIZZINESS, HYPERSENSITIVITY TO LIGHT AND NOISE, LACK OF URINATION, BOUTS OF DIARREAH, CHILLS WITH SKIN ICE COLD TO TOUCH, FREEZING FEET, UNABLE TO DRINK LIQUIDS; COULD NOT EAT FOR 3 DAYS; NO FEVER
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| 69 | 2021-02-16 | nausea |
Took 1st shot and got anxious; a lot of fatigue; felt something in her chest area/chest feeling funn...
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Took 1st shot and got anxious; a lot of fatigue; felt something in her chest area/chest feeling funny; Head spinning; Weakness; nerve pain; stomach nausea; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249, expiry date: unknown), via an unspecified route of administration, in the right arm, on 16Jan2021 14:15 at a single dose for covid-19 immunization. Medical history included left-sided breast cancer from 2005 and lymph nodes removed on her left side. Concomitant medications included pravastatin and a lot of vitamins. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccine administered on same date of the Pfizer suspect. It was reported that the patient took first shot and got anxious on 16Jan2021. The patient also experienced a lot of fatigue on 16Jan2021, went home and got worse then was hospitalized. The patient had a virtual visit with her doctor and wanted some advice, and her doctor didn't give her any prescriptions. The patient also felt something in her chest area on 16Jan2021, after receiving the COVID-19 vaccine. Events anxious and fatigue required emergency room visit. The patient was hospitalized from 25Jan2021 to 27Jan2021 for the events anxious and fatigue. The patient also experienced head spinning, chest feeling funny, weakness and stomach nausea on unspecified date in Jan2021. Reported she was given all kinds of medicine in the hospital. She said as long as she was laying down, she was good. She said once she got up, and moved around, she felt the weakness again. She said she was put on depression medicine (Jan2021) while in the hospital, and was given 4 different prescriptions at discharge. She said the only thing that helps her go to sleep at night is a 1/2 tablet of generic alprazolam for anxiety. She said she knows she can't stay on the generic alprazolam forever, clarifying that is why the doctor put her on the depression medicine. Reported she was given the following medications in the hospital, as well as, prescriptions to continue the medications at home after her hospital discharge: escitalopram 10mg for depression. She said she is to take one escitalopram 10mg every evening for 30 days. She said she was given escitalopram 10mg for the two days she was in the hospital. Generic gabapentin 100mg for nerve pain (Jan2021) and she is to take 1 capsule nightly for 30 days. She said she started the gabapentin 100mg while she was in the hospital. Pantoprazole 40mg, she was given a one-time small IV bag of pantoprazole 40mg for her stomach while she was in the hospital (clarified she was given on 27Jan2021 at 05:26). She said she was having some stomach nausea (Jan2021), and the pantoprazole 40mg was to protect her stomach. She said she told the doctor she didn't want to take the pantoprazole 40mg any longer because she thought she was being given too many different medicines. Reported her fatigue is not the same as it was when she went to the hospital, but the fatigue is still there. Reported her lab work (Jan2021) was good, and her test results were fine when she was in the hospital. She said she was told she was 30% from being on the verge of having heart disease. She said her doctor told her the heart disease was preventable if she eats right, and makes some other changes. She said her cholesterol has gone done. She said she just has the fatigue, and that was why she was put on medicine. Therapeutic measures were taken as a result of the event anxious, fatigue, nerve pain and stomach nausea. Outcome of the event fatigue was recovering while it was unknown for all the other events.
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| 69 | 2021-02-16 | nausea |
69 yo female reports AE after receipt of Covid vaccine #1 (EN 5318 13 FEB 21) via drive thru event. ...
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69 yo female reports AE after receipt of Covid vaccine #1 (EN 5318 13 FEB 21) via drive thru event. She reports within minutes she felt unwell but had difficulty being more specific. She states she felt a warmth in her chest which traveled to her stomach. A few minutes later she felt SOB, and could not catch her breath. She states her respiratory rate increased. She talked to staff and was told if got worse to honk horn or use flashers. She did not request additional assessment. She waited her required 15 minutes and drove home another 20-25 minutes. She states she noted her face swelling. She thinks she may have had some throat swelling, but then wasn't sure. She developed some nausea, but no emesis which continued for 2-3 days. She denied watery or red eyes, runny nose, pruritis, rash, palpitations, heart racing, chest pain, cough wheezing. She states the breathing symptoms resolved in a few hours. She was unsure of the facial swelling resolution time frame. She developed a headache and felt malaise for 2-3 days, then symptoms resolved. She never took any medications other than her prescriptions. She did not seek care during symptom time frame.
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| 69 | 2021-02-17 | diarrhea |
This is a spontaneous report from a contactable healthcare professional (patient). A 69-year-old fem...
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This is a spontaneous report from a contactable healthcare professional (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9261; Expiration date was not reported) on 30Jan2021 (15:00) at a isngle dose on the right arm, with route of administration unspecified, for COVID-19 immunization. Medical history included asthma and allergies to non-steroidal anti-inflammatory drugs (NSAIDS). Concomitant medications included unspecified medications. The patient previously took omalizumab (XOLAIR), and had drug allergy. The patient was not pregnant at the time of vaccination. On 30Jan2021 (17:00), the patient had diarrhea. The patient did not receive any treatment for the reported event. The outcome of the event, diarrhea, was recovered on an unspecified date in 2021. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination.
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| 69 | 2021-02-18 | vomiting, nausea, diarrhea |
Extreme dizzyness, nauseous, vomiting, diarhea. Went to Hospital to get medication and performed tes...
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Extreme dizzyness, nauseous, vomiting, diarhea. Went to Hospital to get medication and performed tests
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| 69 | 2021-02-21 | decreased appetite |
A few hours after getting the vaccine, my arm became sore. It got worse as the night went on. It was...
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A few hours after getting the vaccine, my arm became sore. It got worse as the night went on. It was extremely achy. It was still happening as of Saturday, I also felt lightheaded. I felt like a was on a merry-go-round, it felt like it kept getting faster and faster. I felt dizzy all day Saturday. I had to rest all day. I lost my appetite. Anytime I got up to go to the bathroom, I had to hold something to walk. I also had a mild headache. I felt better on Sunday. My arm was still a little sore as of yesterday but it is better today.
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| 69 | 2021-02-21 | nausea |
After my vaccine, I had problems breathing for about 5-10 minutes. My symptoms were different this ...
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After my vaccine, I had problems breathing for about 5-10 minutes. My symptoms were different this past two weeks. I experienced nausea, dizziness, felt like my brain was on fire. Last week I could not comprehend what people were saying, I did not understand. Extreme irritation, anxiety, depression. Fatigue and tiredness, my legs are weak. My blood pressure went skyrocketed: 169/80.
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| 69 | 2021-02-21 | nausea | During sleep time kept waking up and feeling like I was going to vomit. Headache. |
| 69 | 2021-02-21 | vomiting |
chills; fever; body aches; headache; vomiting; This is a spontaneous report from a contactable consu...
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chills; fever; body aches; headache; vomiting; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A 69-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a sngle dose for covid-19 immunization. Medical history included covid-19 from Nov2020 to an unknown date. The patient's concomitant medications were not reported. She mentioned that she received the vaccine on Sunday (unknown date) and reported that for the last 4 days she had been pretty sick with fever, chills, headache and body aches. She had been alternating acetaminophen (TYLENOL) and ibuprofen (ADVIL). She did have COVID in Nov2020. The patient inquired if the symptoms after dose 2 would be worse if she's had COVID in the past. She also inquired if she will have the same symptoms for the second dose and if how long side effects will last. She add that she did have some vomiting on Sunday later after she got the vaccine. She was wondering because she is to get the second dose on the 21st, the pharmacist did say that sometimes people who have had the Covid virus already can sometimes experience strong side effects from the vaccine. She does not want to feel or get sick. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 69 | 2021-02-22 | abdominal discomfort | Sore arm, slight fever (100.6), fatigue, slight intestinal distress |
| 69 | 2021-02-22 | abdominal pain upper, diarrhea |
sore arm - started about 24 hrs later and lasted about 2 days severe headache - started about 24 hr...
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sore arm - started about 24 hrs later and lasted about 2 days severe headache - started about 24 hrs later and persists still chills and sweating - started about 36 hours later and persists still stomach ache and diarrhea - started the 15th, worsened over days and still persists fever - although I felt like I had a fever i did not record a fever until the 21st-22nd--it was 100.2
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| 69 | 2021-02-22 | diarrhea | Fatigue, headache, diarrhea |
| 69 | 2021-02-23 | diarrhea |
She got the vaccine which was fine, at the end of the 20 minute waiting period had a spot the size o...
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She got the vaccine which was fine, at the end of the 20 minute waiting period had a spot the size of a dime, really sore and pink. On her way home she started having bowel issues, got home and an hour to hour and half later got explosive diarrhea, which lasted 24 hours. The spot on her arm got larger, more tender and felt warm to touch. It got to be the size of a half softball size, no swelling. Then she started having trouble breathing, could not walk as far or fast without breathing problems. She then took it easy, and the breathing issues got worse for 36 hours. On Sunday her arm was better, less sore and the diarrhea had stopped. She then stopped improving and on Tuesday 2/16/21, she was told to go to the minute clinic on 2/18/21 and when she got there her pulse rate was 40, her oxygen level was 93, and her BP was elevated. The NP there she got her oxygen level up to 94, was real raspy in her lungs. She was sent to the UC and they sent her to the ER. She was seen in the ER and isolated her, did an EKG, had a chest x-ray, gave her breathing treatments, and waited on her results, which all came back fine. They gave her 150 mg of Prednisone, another breathing treatment and within 1 1/2 hours her oxygen level was up to 97 and all of her tests were negative and they sent her home. She has now been home since last Thursday with nebulizer treatments Ipratropium bromide and Albuteral sulfate 3 times a day, rescue inhaler 4 puffs every 6 hours, Advair twice a day as well. She does have a FU with her doctor tomorrow for recheck. She feels that she is almost back to normal.
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| 69 | 2021-02-23 | nausea, diarrhea | Violent chills Headache Profuse Sweating Nausea Diarrhea Light-headedness Weakness |
| 69 | 2021-02-23 | nausea |
Got dizzy and nauseous not long after the shot. The next day had a one sided headache which lasted 1...
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Got dizzy and nauseous not long after the shot. The next day had a one sided headache which lasted 1 1/2 days. Very lethargic which I understand is normal. I was concerned about the one sided headache. Was on the left side of my head. The shot was in left arm. Have not idea if that would make a difference.
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| 69 | 2021-02-23 | retching |
Lightheaded or dizzy; Dry heaves; Very warm; Charley horses in both legs; Chills; This is a spontane...
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Lightheaded or dizzy; Dry heaves; Very warm; Charley horses in both legs; Chills; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3302), via an unspecified route of administration in right arm, on 26Jan2021 at 13:15 (01:15 PM), at a single dose, for COVID-19 immunization. The patient's medical history included chronic obstructive pulmonary disease (COPD). The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a doctor's office or urgent care facility. On 26Jan2021 (reported as 12:15 AM; pending clarification), the patient woke up lightheaded or dizzy, with dry heaves, very warm, and with Charley (reported as Charlie) horses in both legs, then she got the chills. This morning (27Jan2021), the patient felt fine. No treatment was administered for the adverse events. The patient was not tested for COVID-19 post vaccination. The patient recovered from the events on 27Jan2021.
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| 69 | 2021-02-24 | nausea, diarrhea |
Racing heart for about 8 hours Diarrhea for 3 days Fatigue for 5 days Headache for 5 days Nausea for...
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Racing heart for about 8 hours Diarrhea for 3 days Fatigue for 5 days Headache for 5 days Nausea for 3 days Muscle pain for 2 days Joint pain (right knee swollen and painful) for 2 days UTI started 4 days after vaccine
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| 69 | 2021-02-24 | vomiting, diarrhea, nausea | Nausea, vomiting and diarrhea |
| 69 | 2021-02-25 | decreased appetite |
Developed fever of 101 degrees, shaking chills, joint and muscle pain, extreme fatigue, lack of appe...
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Developed fever of 101 degrees, shaking chills, joint and muscle pain, extreme fatigue, lack of appetite, which persisted for about 24 hours. Low grade fever present Day 2 after vaccine administered.
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| 69 | 2021-02-25 | blood in stool, gastrointestinal pain, diarrhea |
his wife had blood in her stool, but his wife thinks the blood may be from hemorrhoids; his wife dev...
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his wife had blood in her stool, but his wife thinks the blood may be from hemorrhoids; his wife developed bad diarrhea; Gastrointestinal pain; This is a spontaneous report from a contactable consumer reporting for his wife. A 69-years-old female patient receive the first dose of bnt162b2 (BNT162B2; Lot # EL9262) vaccine , via an unspecified route of administration in the left arm, on 30Jan2021 13:30 at single dose for Covid-19 immunisation . Medical history included clostridium difficile infection 4 or 5 years ago , haemorrhoids. The patient's concomitant medications were not reported. The patient had blood in her stool, but she thinks the blood may be from hemorrhoids on 09Feb2021 with outcome of unknown , his wife developed bad diarrhea on 04Feb2021 with outcome of not recovered , gastrointestinal pain on 04Feb2021 with outcome of not recovered. Hematochetia was considered an Important Medical Event. Course of the event. The reporter said approximately 4-5 days later (Thursday, 04Feb2021), his wife developed bad diarrhea. He said his wife was tested negative for bacteria and virus in her blood. He said his wife still has the diarrhea. He said his wife provided a stool sample to her GI doctor's office yesterday, 10Feb2021, and his wife's stool is being checked for everything. He said his wife has been having 2-3 bowel movements per day. He said the day-before-yesterday (09Feb2021), his wife had blood in her stool, but his wife thinks the blood may be from hemorrhoids. He said his wife has had hemorrhoids before, and her recurring diarrhea has brought the hemorrhoids out. He said his wife has ongoing gastrointestinal pain, as well. Follow up information has been requested.
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| 69 | 2021-02-25 | nausea |
The pressure across my chest and like under my ribs about 6 inch hold away across; I did feel like v...
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The pressure across my chest and like under my ribs about 6 inch hold away across; I did feel like vomiting; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), Batch/lot number: EL9261, via an unspecified route of administration on 22Jan2021 at single dose in left arm for COVID-19 immunisation. Medical history included bypass surgery in Mar, diabetic and seizures from an unknown date and unknown if ongoing. The patient was taking several medications. Patient stated she had the first vaccine (Covid-19 Vaccine by Pfizer) on last Friday and done okay but then she had 10 O'clock in the morning and about 1 O'clock in the morning she woke up with all the pressure across her chest and like under her ribs about 6 inch hold away across and she did feel like vomiting and she was wondering if that was a reaction to that shot and if she should get the second one, she was just kind of concern what she should do it. No treatment was received for the events. The events didn't require Physician Office/ Emergency Room visit. The patient didn't perform any test. The outcome of the events was unknown.
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| 69 | 2021-02-25 | nausea |
On the morning of 2/11/2021, I woke up with SUDDEN HEARING LOSS IN MY RIGHT EAR, was dizzy, had bala...
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On the morning of 2/11/2021, I woke up with SUDDEN HEARING LOSS IN MY RIGHT EAR, was dizzy, had balance issues, and was nauseous. I went to the ER. I had a CT in the ER which also was negative for stroke. My hearing loss has NOT returned, and I still have some balance issues as well for which I am receiving PT.
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| 69 | 2021-02-25 | nausea |
Beginning @ 8 hours following second dose, full range of side effects began, preventing any sleep th...
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Beginning @ 8 hours following second dose, full range of side effects began, preventing any sleep that night, and continuing throughout the entire next day and night (02/24/2021), finally subsiding over the course of the next day (02/25/2021). Side effects included: Injection Site Pain; Tiredness; (raging) Headache; Muscle pain; Chills; Joint pain; What felt like fever (in between shuddering chills) - not evident in temperature; Nausea (non-productive); Feeling unwell; (tender) Lymph nodes. Debilitating and confusing. Glad to have received the vaccine in any case (small price to pay).
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| 69 | 2021-02-25 | retching, nausea |
Was nauseated for a while in bed. Went to bathroom to look for Phenergan. Started to pass out. Ly...
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Was nauseated for a while in bed. Went to bathroom to look for Phenergan. Started to pass out. Lying on floor with dry heaves. Took Phenergan and went to sleep. Next day at 2 PM still dizzy. Pulse 64 sitting. 110 standing. B/P 84/40 standing.
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| 69 | 2021-02-25 | vomiting, diarrhea |
Awaken at 7 a.m. feeling sick and had to get to bathroom, sweating profusely, vomited, feeling very...
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Awaken at 7 a.m. feeling sick and had to get to bathroom, sweating profusely, vomited, feeling very faint, extreme diarrhea, lasyed almost 2 hrs before being able to get up and shower off and go to bed, chills for 2 days and extremely weak. Afraid to get the 2nd shot!
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| 69 | 2021-02-26 | diarrhea | ACHY ARM; JOINT PAIN; HEADACHE; FATIGUE; DIARRHEA |
| 69 | 2021-02-26 | nausea |
Chills, fever, body aches, nausea, headache, mind fogginess, light headed, tired, sleepy ( 36 hours)...
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Chills, fever, body aches, nausea, headache, mind fogginess, light headed, tired, sleepy ( 36 hours) Body aches, nausea, fogginess, light headed, tiredness (2 weeks)
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| 69 | 2021-02-27 | nausea |
Within 10 seconds I began to feel that something was wrong. A full body response of a swirling con...
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Within 10 seconds I began to feel that something was wrong. A full body response of a swirling congestion, extreme weakness. very blurry vision and couldn't think straight. I had trouble walking to recovery room, felt nauseous and weak and had a very fast heartrate. I had to stay in private recovery room for 45 min. I was still very ill and nervous at this point. I left with a family member and asked to be driven to the nearby hospital emergency room. For a precaution . We parked across from ER entrance for another 1 hour till I slowly regained strength to 50% normalcy. I went home afterwards and had to go to bed. I was unable to drive my own vehicle home. Day 2, still feel weak, shaky and not normal. I consider this a serious adverse reaction that did not receive medical intervention but will prevent me from getting the second Pfizer shot. After 5 hours post injection I felt 60% normal . Day 2, 70 per cent normal. The vaccination facility was not able to do blood pressure monitoring ( which is a problem for anyone experiencing reactions.) They said their protocol was to call 911/ambulance. My blood pressure was checked by a certified PA with professional equipment at the 3 hour post injection time and the diastolic pressure was still below 50. And heart rate above normal. Still weak and nauseous.
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| 69 | 2021-02-27 | nausea |
MY heart rate increased to 88 when my normal is 55 and my blood pressure went to 246/120 within the ...
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MY heart rate increased to 88 when my normal is 55 and my blood pressure went to 246/120 within the first five minutes. I felt totally incapacitated, nauseous, lightheaded, "wiped out", generally drugged and ill. This lasted for about 45 minutes and then subsided. For the rest of the day I had periods off and on of feeling exhausted and tired.
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| 69 | 2021-02-28 | abdominal discomfort | Upset stomach |
| 69 | 2021-02-28 | abdominal pain, nausea, decreased appetite |
Day1- headache in nasal sinus area and between eyes, Day 2- muscle aches, joint pain, dizziness, nau...
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Day1- headache in nasal sinus area and between eyes, Day 2- muscle aches, joint pain, dizziness, nausea, lack of appetite. That evening, awoke out of sleep at 3 am with extreme abdominal pain, walked to bathroom and almost passed out, had to lay on the floor for 15 minutes.. After a half our it happened again. No diarrrhea but had 2 soft formed stools (very unusual for me). A lot of nausea, weakness and abdominal pain. Chills for 2 days.
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| 69 | 2021-02-28 | difficulty swallowing |
Feeling numbness in her face around her cheeks and mouth/Her face was really tingling and numb; Feel...
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Feeling numbness in her face around her cheeks and mouth/Her face was really tingling and numb; Feeling numbness in her face around her cheeks and mouth/Her face was really tingling and numb; Difficulty swallowing; Throat started to feel like it was closing up; Tongue got thick; Little blurred vision; This is a spontaneous report from a contactable consumer (the patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, in the right arm on 26Jan2021 at 15:46 PM, (at the age of 69-year) as a single dose for COVID-19 immunization. Medical history included hypertension, pacemaker insertion. Concomitant medication was not reported, however, the patient reported that she takes medicines for hypertension, and is on blood thinners. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported that on 26Jan2021, after receiving the vaccination she did wait a half hour and the only symptoms she thought at the vaccination visit was a little blurred vision, which was temporary and went away. At 16:30, about 45 minutes to 1 hour after she left the vaccination center, as she was driving home, she informed that she was feeling numbness in her face around her cheeks and mouth/face was really tingling and numb, and she had difficulty swallowing; her throat started to feel like it was closing up and her tongue was really thick. She stated she tried to stay calm and forced herself to drink a bottle of water. She had no idea where there was any emergency area since she was not familiar with the area and tried to calm herself down and took sips of water and made sure she was breathing okay and it all went away. The reaction lasted 10-15 minutes and seem to resolve when she was able to calm herself down. She stated it was scary, and once she calmed down it all went away. She was concerned about receiving the second dose. She did not go to a physician or emergency room, but says she probably should have. The clinical outcome of little blurred vision, feeling numbness in her face around her cheeks and mouth/her face was really tingling and numb, difficulty swallowing, throat started to feel like it was closing up, and tongue got thick was recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 69 | 2021-02-28 | nausea |
Initial onset Nausea, headache progressing to fever, chills, severe pain throughout the body at a...
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Initial onset Nausea, headache progressing to fever, chills, severe pain throughout the body at approximately 3:am, lasting approx 30 hrs. Still experiencing moderate headache
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| 69 | 2021-02-28 | vomiting |
muscle spasms; wasn't feeling well; she stumbled again, and fell against her car; too tired; cry; pa...
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muscle spasms; wasn't feeling well; she stumbled again, and fell against her car; too tired; cry; patient with rheumatoid arthritis received Pfizer Covid-19 Vaccine; patient with rheumatoid arthritis received Pfizer Covid-19 Vaccine; headaches/The headache is above her ear and the pain is "past 10"; She recalled experiencing "swelling around her eyes" and "had some swelling" after the 1st dose of the Pfizer-Biontech COVID19 vaccine/left eye swelling; had some swelling; Dizziness/Lightheadedness; Vomiting; Blurry vision; She said the left arm pain started immediately after receiving the COVID-19; Injection site swelling; she is sweating something fierce under her arms; peeing on herself (running to bathroom more); lady asked her to call her when she got home, and she forgot, saying her mind wasn't there; acid reflux taste in mouth/she tasted the COVID-19 Vaccine shot when it was administered; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982; expiration date: unknown) at the age vaccination of 69-year-old via an unspecified route of administration in the upper left arm on 19Jan2021 08:00 (also reported as 11Dec2020) at a single dose for covid-19 immunization. Medical history included was hit by a truck a GM and the truck busted her legs up, ongoing RSD (Reflex Sympathetic Dystrophy) pain since 1991 and was prescribed with oxycodone/acetaminophen (PERCOCET), rheumatoid arthritis from 1991 to an unknown date, spinal cord implant is in her spine, and goes from her spine to her waist, and from her waist to both legs, and down to her ankles from 1991 to an unknown date and migraine when she was 12 or 13 years old. There were no concomitant medications. She received the vaccine in a hospital. The patient previously had a flu shot for immunization but was allergic to the flu shot. It was reported that a patient with rheumatoid arthritis received Pfizer Covid-19 Vaccine on 19Jan2021 08:00. On 19Jan2021, the patient reported that she said she had a slight headache, left eye swelling, dizziness, vomiting, blurry eyes, sweating up under her arms, and peeing on herself (running to bathroom more) after receiving the COVID-19 Vaccine. It was reported that the patient had injection site swelling on 19Jan2021. She said she has never had any side effects like what she is experiencing now after getting the COVID-19 Vaccine. She reported that her mild headache turned severe over the weekend, and she had to wrap a towel around the back of her head, so she could lay down. She said the headache pain was a sharp pain at the bottom of the back of her head and neck. She clarified she had migraines when she was 12 or 13 years old, but the headache pain she had now is nothing like the migraines she had then. She further clarified that her severe headache feels like a knife in the back of her head and neck. She said the pain is more severe on the right side of her head than the left. She said right now she has pressure in the front of her head with a slight headache. She additionally clarified that the swelling in her left eye comes and goes and is persisting. She said her left eye didn't swell close, but her granddaughter told her it looks like something is wrong with her left eye. She added that she had dizziness this morning when she was going to work. She said she stumbled when she was walking this morning but drove to work anyway. She said when she got to work, she wasn't feeling well on an unspecified date, so she decided to go back home. She said when she was walking to her car, she stumbled again, and fell against her car. She reported when she first got the COVID-19 Vaccine (19Jan2021), she was driving in a bad way. She said after she got her COVID-19 Vaccine, she picked up an elderly lady she sits with, and the elderly lady told her she wasn't normal. She said the elderly lady told her she was too relaxed while she was driving, like she was in a daze. She said the elderly lady said she was scared for her and herself when she was driving. She said the elderly lady asked her to call her when she got home, and she forgot, saying her mind wasn't there. She mentioned that she had to wait 15 minutes after receiving her COVID-19 Vaccine (19Jan2021), and when she was driving home, she had to pull over and get out of her car to vomit. She said she had an acid reflux taste in mouth before she threw up. She said she threw up a little bit last night when she had a severe headache. Clarified her eyes are constantly blurry now. She said she has to put her glasses on to see but has to turn her head sideways in order to see anything past her blurriness. She said her burry eyes are worse at night. She stated that she was sweating something fierce under her arms, she said she has to take 3 showers a day now to get rid of the sweating and smell under her arms. She said she has never sweated like that before. She reported her left arm is sore too. She said the left arm pain started immediately after receiving the COVID-19 Vaccine (19Jan2021). She said she has swelling too, and has been rubbing her left arm with alcohol, but the left arm soreness is still there. She reported that she tasted the COVID-19 Vaccine shot when it was administered. She has blown off calling her doctor when she first experienced her side effects, but then her headache got worse. She said she so spoke to doctor 30 minutes before calling Pfizer. She said she told her doctor if her headache comes back, she is going to the emergency room when she gets off work after tonight. She stated that she has been experiencing headaches/muscle spasms that have been getting worse. She says they last 15-20 minutes and then it stops. The headache is above her ear and the pain is "past 10". Yesterday night (unspecified date), the headache was so severe that she wanted to go to the ER but was too tired. The patient reported that she was taking ibuprofen (ADVIL) for her slight headache. She said she took the Advil for a couple days and nights, and her headache eased up some with the Advil. She reported that 2 days ago she bought aspirin, caffeine, acetaminophen (EXCEDRIN MIGRAINE). She also reported that she started taking Ibuprofen when her headaches became severe. She said the Ibuprofen eased the headache, but the headache comes back. Reported she took pain medicine prescribed from a doctor way back, and the prescription pain medication doesn't ease her headache pain. She clarified that the medication was dispensed in a pharmacy was oxycodone, acetaminophen (PERCOCET). She called her doctor when she returned home from work this morning, and her doctor told her to call Pfizer to report her side effects. She reported when she went to work this morning, she got lightheaded. She took Percocet and other medications, but it hasn't relieved it. She says it's not a migraine. She recalled experiencing "swelling around her eyes" and "had some swelling" after the first dose of the Pfizer-Biontech COVID19 vaccine on 19Jan2021. She reported on 02Feb2021 that she was calling back today to report that her headaches were worse. She said her headaches are not a migraine, but more like a muscle spasm in the right side of her head, above her ear. She said the pain is between her neck and ear on the right side of her head. She said the headache pain feels like it is as big as a golf ball. She said her headache pain is so severe, the headache pain wakes her up in a cry. She said the headache pain lasts 15-20 minutes, and then eases up slightly. She said the headaches have been happening twice at night, and twice during the daytime. She said the headache pain doesn't last long. She mentioned that she has been doing self-remedies. She said she ate a spoonful of mustard to ease the headache, and the spoonful of mustard did ease her headache. The patient inquired if she should get the second COVID-19 Vaccine if she is continuing to experience headaches after receiving the first COVID-19 Vaccine. The outcome of the events headache, eye swelling, blurry vision, frequency urinary were not recovered, as for the events dizziness, vomiting, vaccination site pain and vaccination site swelling were recovering, while the outcome of the other events was unknown.
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| 69 | 2021-03-01 | decreased appetite, diarrhea, loss of appetite |
she got the shot on 1/31/2021. Over the next 3 days she developed poor oral intake and diarrhea ev...
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she got the shot on 1/31/2021. Over the next 3 days she developed poor oral intake and diarrhea every 15 minutes; required hospitalization on 2/3/2021. Was hospitalized at Hospital. Hospital course was complicated by sepsis, pressors, intubation, GI bleed with ruptured rectum requiring surgery (ostomy). anticipated discharge 3/3/2021.
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| 69 | 2021-03-01 | decreased appetite |
Woke up (6a) with head ache, body aches, loss of appetite, fuzzy thinking, raised hard area at injec...
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Woke up (6a) with head ache, body aches, loss of appetite, fuzzy thinking, raised hard area at injection site - 5in long, 3in wide - slept most of day. Symptoms mostly gone by 3/2 7am, with exception of raised area at injection site and mild fuzzy thinking. Took two tylenol for headache 6p
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| 69 | 2021-03-01 | burping, abdominal pain upper |
Patient reports that just after leaving the pharmacy she experienced a sharp pain across her entire ...
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Patient reports that just after leaving the pharmacy she experienced a sharp pain across her entire upper abdomen. She did not alert pharmacy staff at that time. She states that the pain continued into the night and became slightly more localized around the gallbladder. She also experienced persistent belching. She came in to the pharmacy on day 2 to report the symptoms and states that she currently continues to be tender to the touch in the upper abdomen and also has some pain when leaning forward. She has not consulted with her doctor as of today and will continue to report to the pharmacy.
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| 69 | 2021-03-02 | diarrhea |
Stuffy nose; Chills; Strong heartbeat; Severe diarrhea; Headache; This is a spontaneous report from ...
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Stuffy nose; Chills; Strong heartbeat; Severe diarrhea; Headache; This is a spontaneous report from a contactable consumer. The consumer reported for herself that the 69-years-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, Lot number: EL9262) via an unspecified route of administration on 17Feb2021 13:00 on Left arm at single dose for covid-19 immunization. Medical history included breast cancer from an unknown date and unknown if ongoing. Concomitant medication included simvastatin, ropinirol [ropinirole] (ROPINIROL [ROPINIROLE]), vitamin d3 (VITAMIN D3). The patient previously took first dose of bnt162b2 (COVID 19 Pfizer Bio Tech) on 27Jan2021 01:15 PM on Left arm for covid-19 immunisation, montelukast and experienced drug hypersensitivity. The patient experienced stuffy nose, chills, strong heartbeat, severe diarrhea, headache all on 18Feb2021 01:15AM with outcome of recovered. She is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received for the adverse event. The event was assessed as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
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| 69 | 2021-03-02 | diarrhea |
shaking; chills; headache; diarrhea; overall body aches; This is a spontaneous report from a contact...
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shaking; chills; headache; diarrhea; overall body aches; This is a spontaneous report from a contactable pharmacist. A 69-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 27Jan2021 at a single dose for COVID-19 vaccination. Medical history included she was previously positive for Covid in Oct2020 to an unspecified date and she received monoclonal antibody treatment (Remdesivir) 3 months prior to her first dose of the vaccine; patient had COPD, oxygen dependent and diabetes from 2016 to an unknown date; and obesity in 2014 to an unknown date. There were no concomitant medications which was reported as patient had not had any other recent vaccinations or started any new medications. Patient received monoclonal antibody treatment 3 months prior to her first dose of the vaccine. Patient probably tested positive and was treated probably the same day she had the positive test (in Oct2020), reporter was sure all of this happened at the hospital, but he doesn't have that information, and the COVID test type was unknown. Reporter's question was related to information about this specific type of patient, having received the monoclonal antibody treatment on 12Oct2020, to an unknown date, which was Remdesivir and also having had COVID then, then having reactions to the dose, would the second dose be necessary, effective, or safe to give to this patient. The patient had her first dose of the Pfizer Covid vaccine 3 weeks ago (estimated as 27Jan2021 by standing order and not prescribed). The patient had general same symptoms listed for side effects of the vaccine that were more severe than others. The patient experienced effects after the first dose of the vaccine as shaking and chills for two days, and headache, diarrhea, and overall body aches (Jan2021). Reporter wanted to know of any studies or research on patients who have been positive for Covid 19 prior to getting the vaccine and treated with monoclonal antibodies and if they do have similar titers to those who have been vaccinated. The reporting pharmacist that the events were serious, and he thought these were medically significant. The patient's symptoms resolved after 72 hours, and reporter did not believe that they did any treatment other than to sleep. The events recovered on an unspecified date in 2021. Information about Lot/ Batch number requested; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events tremor, chills, headache, diarrhoea and pain cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 69 | 2021-03-02 | nausea |
felt hot; nauseous; lost control of bowels; "I knew that I would pass out soon so I lower my head to...
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felt hot; nauseous; lost control of bowels; "I knew that I would pass out soon so I lower my head to the floor and tried to take deep breaths, ...never lost consciousness"; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6201), via an unspecified route of administration in the right arm, on 15Feb2021 at 04:45 (at the age of 69-years-old) at a single dose for COVID-19 immunization. The patient had no medical history. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included trazodone (MANUFACTURER UNKNOWN) and letrozole (MANUFACTURER UNKNOWN). The patient previously took codeine (MANUFACTURER UNKNOWN) for an unspecified indication and experienced allergies, tetracycline (MANUFACTURER UNKNOWN) for an unspecified indication and experienced allergies, doxycycline (MANUFACTURER UNKNOWN for an unspecified indication and experienced allergies, and cyclobenzaprine hydrochloride (FLEXERIL) for an unspecified indication and experienced allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Feb2021 at 01:15, the patient felt hot, nauseous, and lost control of bowels. The events were reported as non-serious. The clinical course was reported as follows: About 8.5 hours (as reported) after the vaccination, the patient briefly felt hot and nauseous. She knew she would pass out soon, so she lowered her head to the floor and tried to take deep breaths. The patient lost control of her bowels but never lost consciousness. The episode was reported to be over in about 20 minutes. The patient did not receive any treatment for the events. The clinical outcome of the events was recovered on 16Feb2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 69 | 2021-03-02 | vomiting |
she was sick for about 8 hours; Throwing up; Unable to keep anything down; Headache; Chills; Ringing...
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she was sick for about 8 hours; Throwing up; Unable to keep anything down; Headache; Chills; Ringing in the ears; Hot flashes; Blood pressure went up; Was so dizzy if she moved her eyes she would nearly pass out; Was so dizzy if she moved her eyes she would nearly pass out; Very weak and tired; Very weak and tired; not feeling well; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; lot number: EL3247; expiration date: unknown) at vaccination age of 69-year-old via an unspecified route of administration left arm on 28Jan2021 10:00 at a single dose for To keep from getting COVID (covid-19 immunization). The patient medical history was none. The patient's concomitant medications were not reported. The patient stated that she got the first vaccine the other day and within 12 hours (28Jan2021 22:00), she was not feeling well. At 8:30 the next morning (29Jan2021), she was sick for about 8 hours. She was throwing up, had a headache, chills, ringing in the ears, hot flashes, her blood pressure went up, she was unable to get anything down, not even medication [pending clarification]. She was so dizzy if she moved her eyes, she would nearly pass out. She could not move out of the chair for about 6-8 hours. The dizziness was severe and awful. She added only one ear is ringing really bad, the right ear. It is off and on and persisting. Her very weak and tired which was persistent. One hour it may be bad and the next she will be drained. The patient inquired if it is true since she heard the second dose is worse. She also wants to know if she should get the second dose or not. The received treatment for the adverse events was reported as none [pending clarification]. The patient underwent lab tests and procedures which included blood pressure (blood pressure measurement) was reported that her blood pressure went up and recovered on 29Jan2021, and weight was 175-180 pounds on an unspecified date. The outcome of the event feeling unwell was unknown, as for the events weakness, tiredness and ringing in ears were not recovered, while the outcome of the other events was recovered on 29Jan2021. Information about Lot/Batch number has been requested.
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| 69 | 2021-03-03 | nausea |
Patient had arm and leg weakness, fatigue, confusion, nausea, body aches that lasted about 48 hours ...
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Patient had arm and leg weakness, fatigue, confusion, nausea, body aches that lasted about 48 hours and are improving.
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| 69 | 2021-03-03 | vomiting, abdominal pain, nausea |
The morning of 3/2 around 4AM - abdominal cramps with nausea (vomited once), achiness, headache, fe...
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The morning of 3/2 around 4AM - abdominal cramps with nausea (vomited once), achiness, headache, fever (100.4) and chills. Felt better by the end of the day. Much better the next day.
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| 69 | 2021-03-04 | diarrhea, nausea |
Jittery a few minutes after the injection that went away Tiredness that lasted about 3 days Cold for...
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Jittery a few minutes after the injection that went away Tiredness that lasted about 3 days Cold for about 4 days but no fever Headaches that were nagging for about 4 days Diarrhea the first that did not last long Nausea that lasted for about 2 eqyw
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| 69 | 2021-03-04 | nausea, decreased appetite |
About 30 hours after the vaccination I experienced dizziness and nausea. Unable to walk easily. No...
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About 30 hours after the vaccination I experienced dizziness and nausea. Unable to walk easily. No appetite. Gradually the nauseous feeling went away (8-9 hours). Dizziness decreased gradually. Within 15 hours most of the dizziness was gone. Checked blood pressure. It was always in the normal range. Able to eat after about 14 hours of the onset of symptoms.
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| 69 | 2021-03-04 | nausea |
TACHYCARDIA, NAUSEA STARTING APPROXIMATELY 10 MINUTES AFTER ADMINISTRATION OF THE 2ND DOSE. ALSO EXP...
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TACHYCARDIA, NAUSEA STARTING APPROXIMATELY 10 MINUTES AFTER ADMINISTRATION OF THE 2ND DOSE. ALSO EXPERIENCED TREMORS GENERALIZED BUT WORSE IN HER HANDS WHICH STARTED APPROXIMATELY 25 MINUTES AFTER INJECTION OF COVID-19 (PFIZER) VACCINE.
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| 69 | 2021-03-04 | nausea | Pfizer-BioNTech Covid-19 Vaccine Chills for 6 hours Nausea Feeling unwell |
| 69 | 2021-03-04 | retching, nausea |
Complaining of nausea, chest tightness, dry heaving. BP 182/106 (pulse 125), 97% O2 sat. Final BP 15...
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Complaining of nausea, chest tightness, dry heaving. BP 182/106 (pulse 125), 97% O2 sat. Final BP 154/97 (pulse 94), 98% O2 sat.
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| 69 | 2021-03-05 | abdominal pain, nausea, vomiting | Nausea, vomiting, bodyache, chills, fatigue, abdominal pain |
| 69 | 2021-03-05 | diarrhea |
One week after Vaccine #1 I began to have swelling & itching of the face-eyes, lips and cheeks, extr...
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One week after Vaccine #1 I began to have swelling & itching of the face-eyes, lips and cheeks, extreme itching of both hands, massive diarrhea and some difficulty swallowing. I took oral benadryl (50 mg) and prednisone (@ 50 mg) and applied cold packs to my face and hands. I also took Allegra 180 mg LA 2x/daily for two weeks after the reaction. Vaccine dose 2 was administered on 2/17/2021 (Pfizer, Lot # EN6201) at Hospital, . One week after that (2/25/2021) I again had facial swelling and itching and massive diarrhea. I took Benadryl 25 mg and Allegra 2x/day and continue to do so. The facial swelling/itching continued. In addition I had, since the first vaccine, extreme fatigue, resulting in a decrease in my ability to walk (down from 3 miles to just over 1 mile) and to swim (shortness of breath, reduction in ability to swim laps). I visited my Rheumatologist on 3/2/2021 and he administered an injection of methylprednisolone to try and tamp down the continuing reaction. That seems to have made a difference.
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| 69 | 2021-03-05 | nausea, decreased appetite |
It started around 8:00 PM on 3/4/2021 with severe pain in the arm, lots of fever, excruciating heada...
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It started around 8:00 PM on 3/4/2021 with severe pain in the arm, lots of fever, excruciating headache, heavy tiredness, chills along with fever. I tried Advil at first. No relief. I switched to Tylenol with the same results. No appetite. Tolerated some Saltine crackers with sips of Coca Cola, and sips of water. Stayed in bed all of 03/05/2021. I didn't stomach any meals, felt like throwing up, but didn't. Today 03/06/2021, left the bed, showered, still running a fever and not feeling like eating.
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| 69 | 2021-03-05 | nausea |
Within minutes of receiving the first dose of Pfizer vaccine, I began feeling dizzy, lightheaded, ...
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Within minutes of receiving the first dose of Pfizer vaccine, I began feeling dizzy, lightheaded, and off balance. This was followed by nausea, itchiness under my lip, fatigue and pain at the injection site. These were gone the next day except for nausea which lasted a few more hours.
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| 69 | 2021-03-06 | nausea, retching |
Around 1 am woke with chills, myalgia, fever to 100.5. Didn't take anti-pyretic. Slept on and off. A...
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Around 1 am woke with chills, myalgia, fever to 100.5. Didn't take anti-pyretic. Slept on and off. At around 3am woke up. Walked to bathroom to urinate. Stood up, started severe nausea and retching. The next thing I remember is finding myself on the ground in the bathroom, retching into the shower area. Called my husband (we are both physicians). My shirt was completely drenched. I was unable to stand up for 5-10 minutes. He noted a 6" hole in the wall (completely through the sheetrock) behind me. I had no memory (and still don't) or falling or hitting my head. He walked me back to bed. My BP was 110/65, pulse was around 70, pulse ox was normal. Continued retching not as severe. Took one Zofran. Eventually fell asleep. In the morning noticed a painful area at the left posterior part of my scalp. There were flakes of sheetrock there. The next day I was tired, felt slightly off balance, otherwise ok. Feeling of vague fuzziness, off-balance continued for a few days, then resolved.
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| 69 | 2021-03-06 | nausea |
I left facility at 3:34 pm where I received the vaccine. At 6:30 pm I became so extremely tired I we...
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I left facility at 3:34 pm where I received the vaccine. At 6:30 pm I became so extremely tired I went to sleep in my clothes. I woke up a few hours later with a pounding headache; the sound of my heartbeat like a snare drum in my ears, nauseated and with a very, very sore arm. Later, throughout the night, I had continuous head pain, nightmares, chills and soreness. I am better today, but still shaky, I took one Naproxen tablet at around 1 am, as well as a melatonin.
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| 69 | 2021-03-06 | nausea | patient became flushed, stated hard to breathe, headache, nausea and back ache |
| 69 | 2021-03-07 | diarrhea |
Severe Diarrhea and fever (about 100) started on day of injection (2-2-21) and lasted about 1 week. ...
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Severe Diarrhea and fever (about 100) started on day of injection (2-2-21) and lasted about 1 week. During this time I noticed loss of movement and strength in both legs. This continued to worsen. By about 2-23-21 (day I received 2nd dose) muscles in legs were very constricted making it difficult to walk. Plus I have lost strength in both hands. Contacted my doctor who refereed me to a Neurologist . The Neurologist ran tests on 3-5-21 that indicate that I have nerve damage. Doing physical therapy in an attempt to loosen muscle constriction and regain strength.
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| 69 | 2021-03-07 | indigestion, nausea | Headache, neck ache, nausea, chills, heartburn.. |
| 69 | 2021-03-07 | nausea |
Vertigo, dizziness & nausea started 3 1/2 days after the first dose. Began at 2 AM in the morning on...
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Vertigo, dizziness & nausea started 3 1/2 days after the first dose. Began at 2 AM in the morning on Feb. 14, 2021. Using meclizine 25 mg tablets 1-2 times a day since then. Had telemed conference with Dr, on Wed., Feb. 17, 2021. ENT appointment scheduled for April 2, 2021. Vertigo continues. Covid 19 (Pfizer vaccine) #2 on March 3, 2021.
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| 69 | 2021-03-07 | nausea |
Swelling of tongue, throat, face, eyes, nausea I dose from Epipen Swelling came down but then came b...
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Swelling of tongue, throat, face, eyes, nausea I dose from Epipen Swelling came down but then came back 911 was called- transported to ER. Given a 2nd dose of Epinephrine en route which caused me to have an immediate heart attack
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| 69 | 2021-03-08 | diarrhea, decreased appetite |
had second covid shot approx. 3 weeks ago, past two weeks has had rash intermittent, decreased appe...
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had second covid shot approx. 3 weeks ago, past two weeks has had rash intermittent, decreased appetite, ache, last weekend had bodyaches/flu symptom, diarrhea. Today has upper lip swelling (3/3/21)
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| 69 | 2021-03-08 | diarrhea, vomiting, nausea |
Very sore arm starting about 4 ours post injection. Couldn't raise it above shoulder level. Felt v...
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Very sore arm starting about 4 ours post injection. Couldn't raise it above shoulder level. Felt very thick and heavy. Throbbing. Pulsating, as though I could feel my heartbeat in my arm when I went to bed. Took to Tylenol or sleep would have been impossible. Woke up to a less painful arm and it improved throughout day feeling almost normal by bedtime 24 hours later. Took 2 Tylenol to ensure sleep. Woke up Tuesday morning and arm felt almost 2100% normal. I thought, wow, that wasn't so bad. BUT I WAS WRONG. Tuesday mid morning, I began to feel what I would describe as jittery. Around 11:00 am a wave of nausea washed over me and subsided. I thought maybe I needed to eat as I hadn't yet so I had lunch. After lunch I began to feel nauseous again and like diarrhea was coming. After going to the bathroom, the nausea started building again, and the diarrhea recurred, and the nausea heightened. By mid afternoon I was on the floor hugging the toilet bowl wanting to vomit, waiting to vomit, groaning. It's been years since I've had nausea or vomiting and the whole experience was unexpected from what I read about possible reactions. I wondered if it was food poisoning but my husband and I had eaten the same thing and he was fine. Finally about 3:30-4:00, 48 ours post vaccine, I threw up multiple times, perhaps 5 times. After about 4:30 pm it was over. I was worried that if I ate again I'd be sick so I only drank decaf tea. I felt exhausted from the ordeal but very wired and jittery too. I crawled into bed hoping for sleep. No luck. At 3:00 am I was still watching the clock and shocked that I couldn't sleep. I had to get up at 6:30 in the morning due to some construction at our home. I was legit exhausted Wednesday. I no recurrence of the nausea or diarrhea after the bout on Tuesday afternoon. I ate modestly but normally on Wednesday and slept normally Wednesday night. Nothing more to report, although I read that up to a week later some people experienced a reaction so I wanted to give it a week to see if anything else would happen. Nothing else to report.
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| 69 | 2021-03-09 | constipation, decreased appetite |
Wednesday, the morning after the shot: 101.7 fever and in bed all day; chills/cold; can "feel my ...
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Wednesday, the morning after the shot: 101.7 fever and in bed all day; chills/cold; can "feel my skin;" stomach and diet off; bowels off; chest and upper back pressure; deliberate taking of a deep breath; tinny taste in my mouth; slightly headache; low energy; Thursday, the second day after the shot: 99.7 temp; stomach and diet off; chest and upper back pressure; deliberate taking of a deep breath; tinny taste in my mouth; thirsty Friday, day three: stomach and die off; chest and upper back pressure; deliberate taking of a deep breath; tinny taste in my mouth; thirsty Saturday, day four: chest and upper back pressure; deliberate taking of a deep breath; tinny taste in my mouth Sunday, day five: chest and upper back pressure; deliberate taking of a deep breath Monday, day six: chest and upper back pressure; deliberate taking of a deep breath Tuesday, day seven: chest and upper back pressure; deliberate taking of a deep breath Wednesday, day eight: chest and upper back pressure; deliberate taking of a deep breath
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| 69 | 2021-03-09 | nausea |
Received COVID vaccine on 2-22-2021 an hour later started to have right arm pain at the site of the ...
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Received COVID vaccine on 2-22-2021 an hour later started to have right arm pain at the site of the injection. Since has had multiple issues and concerns, such as SOB, dizziness, joint and right arm pain, fatigue and nausea that started about an hour after receiving her vaccine. She said she has SOB at rest but with any type of exertion she is gasping for air. Rates her joint pain off the charts with walking and is bent over.
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| 69 | 2021-03-09 | nausea |
AFTER RECEIVING PFIZER COVID-19 VACCINE #2, I EXPERIENCED "NORMAL" FLU-LIKE SYMPTOMS FIRST DAY AND 1...
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AFTER RECEIVING PFIZER COVID-19 VACCINE #2, I EXPERIENCED "NORMAL" FLU-LIKE SYMPTOMS FIRST DAY AND 1/2. ON SECOND DAY, AWOKE WITH SLIGHT HEADACHE AND SEVERE LEFT NECK PAIN, UNABLE TO MOVE HEAD FROM SIDE TO SIDE. FELT NAUSEAUS ON AND OFF ALL DAY. THE NEXT MORNING BEFORE WAKING, I COULD FEEL THE PAIN MOVING FROM THE LEFT TO THE RIGHT SIDE BEHIND MY NECK, FROM EAR TO EAR. THIS IS CONTINUING ON DAY 4 WITH NO RELIEF. CALLED MY PROVIDERS' OFFICE WHERE NURSE TOLD ME SHE HAD THE VERY SAME THING THAT LASTED 2 WEEKS, NECK PAIN PLUS FATIGUE. I HAVE NOT FOUND ANY INFORMATION RE. THIS SYMPTOM ONLINE.
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| 69 | 2021-03-10 | diarrhea, decreased appetite, vomiting |
Within 2 hours of 2nd shot Ibegan to feel weak and began vomiting around 6pm. Also having diarrhea ...
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Within 2 hours of 2nd shot Ibegan to feel weak and began vomiting around 6pm. Also having diarrhea in ileostomy bag. I did not sleep Monday 3-8 night. Vomiting .stopped the next day. Little appetite. Temp 3/11 was 99.3 slightly high. No adverse event after first dose 2/15/21.
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| 69 | 2021-03-10 | difficulty swallowing, nausea |
02/11/2021 Noon - severe nausea 2200 - nausea resolved 2330 - extreme fatigue which continued throug...
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02/11/2021 Noon - severe nausea 2200 - nausea resolved 2330 - extreme fatigue which continued through 03/06/2021 then became moderate fatigue - continues to present. 02/12/2021 0030 - dry raspy cough - continues to present but lessened in intensity over time. HISTORY 01/2020 01/08/2020 - felt fine at movie theater, while walking to car swallowed & became aware that my throat was suddenly quite sore - difficult to swallow. Within 15min throat so sore could hardly swallow. Had start of dry cough. ON increased dry cough; HA; joint pain; sweats/chills; low grade fever. 01/10/2020 - HA resolved. Sore throat less painful; very uncomfortable dry cough. Extreme fatigue. 01/11-19/2020 - Due to fatigue, unable to be out of bed for more than a few minutes. Hydrating/soup. Couldn't carry on verbal conversation due to dry cough - no SOB if didn't try to talk. 01/20/2020 - Was able to get up & dressed; left house for short time. Felt better, cough less of problem but persisted. Took about 3-4 weeks to feel 100%. AN ASIDE My osteoarthritis pain, in left hip only, began to get much worse after 01/2020 episode. It took a quantum leap forward in pain again after 1st COVID-19 vaccination.
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| 69 | 2021-03-10 | vomiting, abdominal pain |
flu-like symptoms; fever; chills; aches/pains; vomiting; abdominal pain -feels like severe case of t...
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flu-like symptoms; fever; chills; aches/pains; vomiting; abdominal pain -feels like severe case of the flu; This is a spontaneous report from a contactable nurse reported for self. This 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EL9267) at single dose on 09Feb2021 14:15 in left arm for COVID-19 immunisation. Medical history included severe respiratory infection from Nov2019. Patient thought she might have had COVID, but she was way early, before anyone knew it was in the country, back in Nov2019, she had a severe respiratory infection. Patient stated that her husband was a respiratory therapist, and he fortunately had enough albuterol to choke a horse with, and if it had not been for that and the nebulizer, the caller would have had to go to the hospital. Patient stated that she would wake up in the night and need three or four treatments. Patient stated that before being sick, she had horses and it would take 15-20 minutes to do her routine with the horses, but while she was sick, it took two hours. Patient stated that she would walk out and back, and it was an ordeal, she was tired and short of breath. Patient stated that the doctors called it severe respiratory inflammation, and that was in Nov and Dec2020. Patient stated that she was put on steroids at that time, and she really didn't want to go back to the doctor, so she took some of her husband's steroids, he had some dexamethasone, and she took that and started to feel better. There was no concomitant medication taken. Patient reported flu-like symptoms on 11Feb2021 after her first dose of Pfizer Covid19 vaccine. Symptoms included fever, chills, aches, pains, vomiting, abdominal pain -felt like severe case of the flu on 11Feb2021. Patient would like to know if these were normal adverse events and if they could be worse for her, because she may have had a Covid infection previously. Patient asked what was the efficacy after one dose of the Pfizer-Biontech Covid19 vaccine if she chose not to get the second dose. Patient took her first dose of the Pfizer COVID vaccine on 09Feb2021. Patient stated that two days later, she had side effects and had had them for the last 6 days. Patient stated that if someone picked it, she had it. Patient stated that she had a fever, chills and pain. Patient's fever was running at 102.5 in Feb2021, and she could get it down with paracetamol (TYLENOL) and alcohol. Patient stated that she heard somewhere that the first dose offers 85% protection against the virus, and she was wondering if that was accurate. Caller was scheduled for her next dose on 09Mar2021. Patient was still having aches and pains, and she had vomiting. Patient stated that she was still not over this part of it yet. Patient stated that her side effects started on 11Feb2021 between 4 and 5PM, so more than 48 hours later and they all of a sudden just hit her. Patient stated that the vomiting had stopped, but she did still get some abdominal pain once in a while, but the vomiting stopped about two days ago, but for a while she could not keep food down, and she was just trying to take paracetamol (TYLENOL). For events fever, chills, aches and pain, patient confirmed that these were all still ongoing, but they were getting better. Patient stated that these side effects were a little better yesterday, the caller got up and took a dexamethasone 5 mg and felt better. Patient stated that when she woke up this morning, she was feeling god awful, so she took another dexamethasone, and she was better this afternoon. Patient planned to go to an urgent care today, but she had not been to a doctor yet. Patient stated that they must not have been that serious because she did not go to a doctor, it was like a bad case of the flu, feeling like she got run over with a truck. Patient stated they were serious, but nothing life threatening, caller confirmed all side effects were medically significant. Patient stated that she read that people who had COVID, would react with more severe side effects to the vaccine than people who did not have COVID, and she was wondering if that was correct. The outcome of event vomiting was resolved in Feb2021, outcome of event abdominal pain was unknown. The outcome of rest events was resolving. The patient assessed drug result was related for all the events, Method of assessment: Global Introspection.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "flu-like symptoms and associated fever, chills, aches, pains, vomiting, abdominal pain " and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. More information such as complete medical history and concomitant medications are needed for fully medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 69 | 2021-03-11 | abdominal discomfort, diarrhea | Stomach issues and diarrhea lasting 2 days |
| 69 | 2021-03-11 | abdominal pain, diarrhea | Abdominal cramping, diarrhea |
| 69 | 2021-03-11 | diarrhea, decreased appetite |
Pfizer COVID-19 Vaccine EUA 3/2: Pt received Pfizer vaccine 2/26/2021 and started feeling progressi...
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Pfizer COVID-19 Vaccine EUA 3/2: Pt received Pfizer vaccine 2/26/2021 and started feeling progressively worse - endorsed fever, diarrhea, body aches, trouble breathing, lack of appetite. On 3/2/2021 pt and husband presented to ED. Pt's husband stated that pt had become more and more confused since she received the vaccine and that on 3/2 she could not complete her sentences. Temp 101.6 on arrival, tachycardic in 130s, tachypneic in 120s, but not hypoxic. Patient was given acetaminophen on arrival. IV was inserted and patient was given 1 L intravenous fluid replacement as well as 2 g ceftriaxone for broad-spectrum coverage within 3 hours of arrival. Blood work was drawn that shows no leukocytosis but lactic acidosis to 3.3. There are multiple electrolyte abnormalities, hyponatremia 127, hypokalemia 2.8, creatinine 1.01, ALT 59 AST 53, ALP 136, total bili 1.3, lactic acidosis 3.3, troponin 0.02. Patient was given 40 mEq of oral potassium. Additional L of normal saline was given for total of 2 L normal saline bolus. Chest x-ray shows right basilar pneumonia. Also shows pulmonary nodule of which husband was made aware. LFTs are noted be elevated, so biliary ultrasound was obtained that was negative with limit to body habitus. Husband was updated. Azithromycin was added on. Rapid COVID antigen was negative. 3/3/21: Febrile, SOB overnight. Pt more lethargic, trailing off in the middle of sentences and having difficulties following conversation. Continue sepsis protocol, add vancomycin IV to ceftriaxone and azithromycin. Frequent neuro checks. MRCP. Chest pain-free, serial cardiac enzymes from yesterday to demonstrate nonischemic pattern likely type 2 NSTEMI. 2/2 blood cultures from 3/2 positive for Streptococcus pyogenes (Group A). Vancomycin and azithromycin dc'd. 3/11: Discharged from hospital. Patient admitted for acute hypoxic respiratory failure secondary to right basilar community-acquired pneumonia. Blood culture grew Streptococcus pyogenes, patient was initially treated with ceftriaxone and switched to Ancef . repeat blood culture on 03/04/2021 showed no growth. Patient will complete a total 14 day course of antibiotics with amoxicillin from culture negative date. Patient had right-sided pleural effusion, pulmonary consulted and she underwent thoracentesis x2 culture showed no growth, considered parapneumonic effusion. Patient required 2 L continuous oxygen and deemed stable for discharge. She will follow up with Pulmonary in 3 weeks, outpatient chest CT in 4-6 weeks to be ordered by Pulmonary to assess lung nodule and known thoracic aortic aneurysm. PTOT recommended home discharge with VNA. On discharge patient was a febrile and hemodynamically stable. Remained COVID negative throughout.
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| 69 | 2021-03-11 | nausea | Nausea which patient had prior to arrival due to antibiotic therapy |
| 69 | 2021-03-11 | nausea | Chills, fever, headache, tiredness, nausea, injection site pain, muscle pain |
| 69 | 2021-03-12 | nausea, vomiting | Altered mental status, moderate dehydration, nausea and vomiting; Addison?s crisis |
| 69 | 2021-03-12 | nausea |
I was very dizzy. The room was spinning very fast and I became nauseated with a bad headache. The s...
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I was very dizzy. The room was spinning very fast and I became nauseated with a bad headache. The symptoms were worse the first day and lasted for a week. I took Dramamine for the dizziness and Tylenol for the headache.
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| 69 | 2021-03-13 | abdominal pain upper, flatulence, abdominal distension |
Face and neck swelled up, faster heartbeat, a day later severe bloating, gas, stomach cramps, stom...
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Face and neck swelled up, faster heartbeat, a day later severe bloating, gas, stomach cramps, stomach cramps lasted several days
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| 69 | 2021-03-14 | decreased appetite, vomiting |
Next day after shot: Fatigue first, vomited once, had chills, temperature 101.8, reduced appetite. ...
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Next day after shot: Fatigue first, vomited once, had chills, temperature 101.8, reduced appetite. Following day okay except for sore arm, fatigue, lack of appetite.
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| 69 | 2021-03-14 | diarrhea, nausea |
Injection site red and swollen., Nausea and diarrhea. Headache,. Tiredness. Muscle pain. Temperature...
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Injection site red and swollen., Nausea and diarrhea. Headache,. Tiredness. Muscle pain. Temperature (102). Severe chills.
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| 69 | 2021-03-14 | diarrhea | Diarrhea, severe joint pain |
| 69 | 2021-03-14 | nausea, vomiting |
My only reaction to Shot #1 was feeling fatigue for about a day It was Shot #2 that I had a reaction...
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My only reaction to Shot #1 was feeling fatigue for about a day It was Shot #2 that I had a reaction. Approximately 20-25 minutes after the shot, while driving home, I felt dizzy and light-headed. By the evening, I had a fever, chills, headache, body aches, pain in my left arm (shoulder, elbow down to my wrist); nausea and vomiting. Condition lasted Tuesday evening and throughout Wednesday. By Wednesday evening I felt a little better and by Thursday afternoon, most of the symptons had dissipated
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| 69 | 2021-03-14 | nausea | Very hard chills, fever, nausea, night sweats & dizziness |
| 69 | 2021-03-14 | nausea | Fever, chills, body aches, headach, fatigue, slight nausea |
| 69 | 2021-03-15 | abdominal distension, indigestion, flatulence |
experienced lots of gas - indigestion - bloating feeling. Vaccine on Tuesday, March 9th, and other...
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experienced lots of gas - indigestion - bloating feeling. Vaccine on Tuesday, March 9th, and other symptoms started Friday, March 12, so not sure if related. Lasted 3 days.
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| 69 | 2021-03-15 | nausea |
Blacked out; fractured nose; fainting; very tired and cold; very tired and cold; light headed; thirs...
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Blacked out; fractured nose; fainting; very tired and cold; very tired and cold; light headed; thirsty; nausea; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9266), via an unspecified administered in the left arm on 13Feb2021 at 08:15 AM at SINGLE DOSE for COVID-19 immunisation. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient was not pregnant at the time of vaccination. Medical history included arthritis (No chronic health conditions besides arthritis). Concomitant medications included venlafaxine hydrochloride (EFFEXOR), simvastatin, and colecalciferol (D3). The patient previously took cipro [ciprofloxacin hydrochloride] and experienced allergies. Historical vaccine includes first dose of (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9262), via an unspecified route of administration in the left arm on 22Jan2021 at 5:00 PM for COVID-19 immunisation. It was reported that for 2 days, patient was very tired and cold. At day 4 while at her trainer, the patient experienced light headed, thirsty, nausea, and had blacked out. All tests were normal at emergency room (ER), but have fractured nose. The patient wanted to understand if this fainting can be related to the second shot. Cardiologist said no problems in the heart. All events started on 17Feb2021. There was no treatment received for all events. The patient had COVID test post vaccination via nasal swab on 17Feb2021 which showed negative result. On an unspecified date in 2021, the patient recovered from all events.
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| 69 | 2021-03-15 | nausea |
Chills, shakes, headache, nauseous and full body aches for 6 hrs. Temperature for 3 days started at ...
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Chills, shakes, headache, nauseous and full body aches for 6 hrs. Temperature for 3 days started at 102 for 4 hrs. Then down to 101 - 100 next 24-36 hrs. Next 24 hrs temp. was 99. - 100. Chills, shakes and nauseous came back again 72 hrs later and lasted about 4 hrs. Headache and nauseous lasted a large part of 3 days. Took Tylenol when symptoms first started and stopped after 3 days when symptoms completely stopped.
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| 69 | 2021-03-15 | vomiting, nausea |
16 hours after receiving the shot, I woke up with a very rapid heartrate (120). It did slow down so...
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16 hours after receiving the shot, I woke up with a very rapid heartrate (120). It did slow down somewhat (to the 90s) after a while. However, sporadically over the next few days, I did feel it was elevated. Later that day, one day after getting the shot, I developed a severe migraine headache--which included nausea and two bouts of vomiting (1 in the late afternoon and one in the evening of March 12th). The headache resolved sometime on Sunday, March 14th although I felt a bit weak and shaky. Currently, five days after receiving the shot, I feel a bit "shaky", and feel that my heartrate is rapid on occasion.
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| 69 | 2021-03-16 | diarrhea, vomiting, abdominal pain upper |
First Dose: 02/07/2021 I have lymphedema in my legs and 4 hours after the injections my legs got ver...
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First Dose: 02/07/2021 I have lymphedema in my legs and 4 hours after the injections my legs got very painful. I also had a bad headache. Second Dose: 03/16/2021 2 hours later I had severe vomiting and diarrhea and cramping in my stomach. feels like labor pains
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| 69 | 2021-03-16 | indigestion, gastrointestinal pain, diarrhea |
On day of 2nd vaccine, suffered extreme indigestion. Stomach had not been right since. Always very l...
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On day of 2nd vaccine, suffered extreme indigestion. Stomach had not been right since. Always very loose stools, often with what appears to be oily droplets floating on top. Frequent digestive cramping.
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| 69 | 2021-03-16 | nausea, vomiting |
Late afternoon on 3/16/2021, I became dizzy. Then I became quite dizzy to where I had to sit down. ...
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Late afternoon on 3/16/2021, I became dizzy. Then I became quite dizzy to where I had to sit down. my head began to hurt as well and I became nauseous. I went to my bedroom to lay down and took a pail with me in case I became sick to my stomach. I did throw up three separate times. The dizziness persisted throughout the night. by this morning, 3/17/2021 I felt better for the most part.
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| 69 | 2021-03-16 | nausea |
Today, 03/17/2021, at 530 pm: light-headed, dizzy, nausea - so dizzy I can not walk. I have eaten an...
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Today, 03/17/2021, at 530 pm: light-headed, dizzy, nausea - so dizzy I can not walk. I have eaten and am hydrated. And the symptoms persist. I have felt bouts of light-headedness, dizzyness, and tinges of nausea that are mild since I got the 1st shot, but not prior to that. Six hours after the first shot, i felt dizzy, nauseous =and it dissipated by an hour and disappeared entirely by late the next morning (1/22/2021). After the second shot, I had no side effects. However, as i described above, I have felt slight nausea and lightheadedness during the past month or so. But this is very serious. And I am scared to walk.
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| 69 | 2021-03-17 | nausea |
Low grade fever ( 100.3), joint pain, severe fatigue, mild nausea Dizziness ( fogginess) "Flu-like" ...
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Low grade fever ( 100.3), joint pain, severe fatigue, mild nausea Dizziness ( fogginess) "Flu-like" symptoms for 48 hours
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| 69 | 2021-03-18 | abdominal discomfort |
Increased blood pressure and heart rate. Chills - fever- headache - body aches - sick to my stomach ...
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Increased blood pressure and heart rate. Chills - fever- headache - body aches - sick to my stomach - tireness - swollen and red arm at injection site along with some itching. Woke up with these symptoms next day after vaccine. Blood pressure, heart rate, and other symptoms were better by day 2 but swollen arm and redness still persists. Still have a slight headache.
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| 69 | 2021-03-18 | abdominal pain upper |
Sore arm; body aches; fatigue; headache; upper stomach cramp; chills; sensitive skin; symptoms got w...
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Sore arm; body aches; fatigue; headache; upper stomach cramp; chills; sensitive skin; symptoms got worse; This is a spontaneous report received from contactable consumer, the patient. A 69-year-old elderly female received the first dose of BNT162b2 (solution for injection; Lot EN6201 expiry not provided) as a single dose via unspecified route in the right arm on 14Feb2021 at 11:30 AM (at 69-years-old) for COVID-19 immunisation. Relevant medical history included asthma, hypothyroidism, and high blood pressure (BP). The patient has an allergy to penicillin, sulfonamide (sulfa), eggs, shellfish and peanuts and all tree nuts. Concomitant medications sans posology/indications included levothyroxine sodium (SYNTHROID), valsartan (DIOVAN), atenolol (TENORMIN), amlodipine, and diazepam (VALIUM NOVUM). The patient did not receive any other vaccines on the same date. The patient denied being diagnosed with COVID-19 prior to the vaccination. The patient reported that on 16Feb2021 at 05:00pm she experienced a sore arm, body aches, fatigue, headache, upper stomach cramps, chills , sensitive skin (no hives) and these symptoms got worse on the second day and continue (fifth day not including day of vaccine), The patient was tested for COVID via nasal swab PCR on 19Feb2021 and was negative. There was no treatment received. The outcome of the events, sore arm, body aches, fatigue, headache, upper stomach cramps, chills, and sensitive skin (no hives), was not recovered.
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| 69 | 2021-03-18 | diarrhea, flatulence |
APPROXIMATELY 13 MINUTES after receiving my first dose, my stomach started to gurgle and create gas....
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APPROXIMATELY 13 MINUTES after receiving my first dose, my stomach started to gurgle and create gas. Had an incident of uncontrollable diahrrea. Morning breakfast passed with most vegetables( shredded cabbage, carrots and frozen peas intact. NO pain, just humiliation in not being able to get to a porta potty. Fortunately, I was in my car for the entire vaccine procedure and could drive home to clean up.
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| 69 | 2021-03-18 | nausea, abdominal pain, abdominal discomfort |
woke up 2:00 am 3/19 with abdominal cramps; stomach discomfort, vague nausea, intestinal cramps. Had...
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woke up 2:00 am 3/19 with abdominal cramps; stomach discomfort, vague nausea, intestinal cramps. Had 2 bowel movements, soft but not diarrhea, slight sweats. Most of the night had difficulty sleeping, very restless. Upon waking, still very tired, fuzzy feeling, but no more abdominal issues.
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| 69 | 2021-03-19 | appendicitis | Appendicitis on 3/9/21 |
| 69 | 2021-03-19 | decreased appetite, nausea |
Had a fever from 101.4 - 101.9 from onset through late evening on 3/19. Treated with Tylenol that lo...
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Had a fever from 101.4 - 101.9 from onset through late evening on 3/19. Treated with Tylenol that lowered the fever but didn't take it away. Other symptoms included nausea, loss of appetite, muscle aches, pain in both eyes, pain in the lower backside of my head, pain at injection site. Fatigue. Slept all day and through the night. 3/20/2021 8:50 am - as I complete this form I still have side effects even though most symptoms are gone now; Currently, extremely fatigued with a headache that is at the back of my head only. Soreness at injection site. Other symptoms are gone.
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| 69 | 2021-03-19 | nausea |
Two hours after receiving my second vaccine I became very tired. Roughly 12 hours after that (1 am)...
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Two hours after receiving my second vaccine I became very tired. Roughly 12 hours after that (1 am), I awoke with chills and shakes. When I awoke in the morning, I experienced headache, fever (99.9), body aches, chills and slight nausea. These symptoms lessened towards the end of the day. I awoke during the night (about 24 hours after first experiencing chills) in a pool of sweat. Although I didn't take my temperature, I felt like my fever had broken and most other symptoms were gone. The following morning I felt weak and tired.
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| 69 | 2021-03-20 | diarrhea, nausea |
extreme headache, extreme eye ache, aching joints, queasy stomach, low fever, diarrheas. Lasted 2 da...
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extreme headache, extreme eye ache, aching joints, queasy stomach, low fever, diarrheas. Lasted 2 days
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| 69 | 2021-03-20 | diarrhea, nausea | Headache, diarrhea, nausea, welts on face, general weakness and body pains. |
| 69 | 2021-03-20 | nausea | Nausea, headache, sweating, overall body aches |
| 69 | 2021-03-20 | nausea |
passing out; I fell on a tile floor & hit my head resulting in a 1.5 inch gash in the back of my hea...
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passing out; I fell on a tile floor & hit my head resulting in a 1.5 inch gash in the back of my head; I fell on a tile floor & hit my head resulting in a 1.5 inch gash in the back of my head.; Chills; fatigue; nausea; lightheadedness; vertigo; This is a spontaneous report from a non-contactable consumer (patient). A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EM9810) via an unspecified route of administration, administered on the left arm on 26Feb2021 15:15 at a single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included calcium carbonate (OS-CAL) and vitamin. The patient previously took BNT162B2 for COVID-19 immunisation (first dose on the left arm at 01:30 PM, lot number: EL 1283); and SHINGRIX vaccine in 2019, codeine and cipro and experienced allergies. On 27Feb2021 03:30 PM, the patient experienced chills, fatigue & then sudden nausea & lightheadedness that resulted in passing out. Unfortunately, the patient fell on a tile floor & hit her head resulting in a 1.5 inch gash in the back of her head. When she went to the ER, it was determined that she now had vertigo (which she never had before) but obviously hard to tell if it was a side effect of the vaccine or from the fall. The events resulted to a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment for the events which included CT scan, ekg, chest X-ray, bloodwk (unknown results) and Epley maneuver. The facility where the vaccine was administered was in a workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Patient is not pregnant. Outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 69 | 2021-03-20 | nausea |
I was up set; Muclse spams feel like something crawling in my leg; I feel crap. I got to work but fe...
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I was up set; Muclse spams feel like something crawling in my leg; I feel crap. I got to work but feeling like I do I can't work; a slight temp 90.2; had choking episodes; feels like her throat is closing up when she is eating; Food get stuck in my throat; sleeping all day; tired; Headache; Nausea; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN6201; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in left arm on 05Mar2021 as single dose for COVID-19 immunisation. Medical history included food allergies and meds allergies, anxiety, depression and blood pressure (abnormal). Concomitant medications included clonazepam (KLONOPIN) taken for anxiety from 2001, buspirone (BUSPIRONE) taken for anxiety from 2001, bupropion hydrochloride taken for depression from 2001, bupropion hcl taken for depression from 2001, and amlodipine besilate taken for blood pressure abnormal from 08Mar2021. On 05Mar2021 19:00, the patient experienced headache, and nausea. On 06Mar2021 19:00, the patient experienced sleeping all day, and was tired. On Day 2, she still had more side effects which wake her up. On 10Mar2021 19:00, the patient experienced had choking episodes, feels like her throat is closing up when she was eating, and food got stuck in her throat. On an unspecified date, the patient was upset and muscle spasms felt like something crawling in her leg and felt "crap"; she got to work but feeling like can't work. The patient reported that she had been having side effects and she was scared to have the shot because of her side effects and have when her body don't recognize it. She was asking when they go away. She has had a headache and nausea, was tired and sleeping all day. She felt like her throat was closing up when she eats. She had a choking episode and her grand daughter had to hit her on her back. She had choking episodes last night and this morning and she was now eating soft foods. She saw her doctor Monday for a regular appointment and she told him what happened. He wanted her to take the second dose but she was afraid to take it. She was afraid she will have worse side effects. Right now, she had nausea and drinking ginger ale. Her doctor called her which she was upset because he haven't seen her at all. Last time was 2019; and she just told him how she feel and want person to person. Patient reported she was not going to take 2nd dose because she do not want to go through anymore side effects. Everyone said that there were no side effects. That's wrong and she was having side-effects from day 1 on Friday night. There was an ingredient which she has allergies to. She told the nurse all meds allergies and food allergies which they told her that nothing in it will cause any side effects. They were wrong. She felt crap and she got to work but feeling like she can't work. Patient refused to take 2nd dose. Patient stated that she do not want to go through what she was going through now. The patient reported that she had a slight temp 90.2 on an unspecified date. The events required a visit to the physician office. The patient had no prior vaccinations (within 4 weeks). Outcome of events choking episodes, nausea, tired, feels like her throat is closing up when she was eating, Food get stuck in my throat was not recovered; sleeping all day was recovered on 07Mar2021; headache was recovered on 10Mar2021; and outcome of the rest of events was unknown.
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| 69 | 2021-03-21 | diarrhea |
Pain at site in arm, March 16th (day after) Diahhrea & low grade fever March 17th, 18th Friday, M...
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Pain at site in arm, March 16th (day after) Diahhrea & low grade fever March 17th, 18th Friday, March 19th, itching at injection site on left arm, no pain just very, very itchy Took Immodium, Wed 17th & 18th and Tylenol for low grade fever, sweating. Took Benadryl Sat. 20th after topical did nothing, Today, March 21st. No pain in arm just continues to itch at injection site
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| 69 | 2021-03-21 | nausea | headache, nausea, fatigue |
| 69 | 2021-03-21 | nausea |
I felt dizzy, nausea, felt unwell, weak, faint, started to slump over, was collapsing, hands turn re...
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I felt dizzy, nausea, felt unwell, weak, faint, started to slump over, was collapsing, hands turn red, tightness in the upper part of my body, lips tingling, tightness / swelling in my cheeks and mouth, very severe headache. I was rushed over to ER. Next day still had tingling of lips, felt unwell. By third day, felt better. I had an anaphylactic reaction to the vaccine. Three of my systems were adversely effected. Dr. and others are UNDERREPORTING the anaphylactic reactions cases. Just because I didn't die or an Eppie Pen was not given to me. doesn't mean I should not be included in the statistics.
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| 69 | 2021-03-22 | diarrhea | I had diarrhea the following evening. |
| 69 | 2021-03-22 | nausea |
Symptoms: Severe headache, nausea, muscle aches, very tired, left arm pain, dizziness, weakness - be...
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Symptoms: Severe headache, nausea, muscle aches, very tired, left arm pain, dizziness, weakness - began some time in early morning of March 21 Called Emergency Room. Spoke to ER doctor who recommended: 2 Tylenol, 1/2 Benadryl, plenty of fluids, eating light, light activity level I followed these except used only 1 extra strength Tylenol which I repeated twice during the day. Spent most of day sleeping. Improvement by morning of March 22. March 22 - tiredness continued so limited activity.
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| 69 | 2021-03-22 | vomiting, nausea |
Patient had adverse reaction to shot #1 including rash, increased heart rate, nausea so she decided ...
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Patient had adverse reaction to shot #1 including rash, increased heart rate, nausea so she decided that she wanted to get Moderna instead of Pfizer. Appointment was scheduled and she received her 2nd shot Moderna. Side effects included 3 days of severe symptoms of fatigue, nausea, vomiting, chills, fever and over all severe body aches. Aside from the above, no other reactions noted from 2 different vaccines. Patient was called and educated.
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| 69 | 2021-03-22 | vomiting |
Severe vomiting repeatedly the night/morning after injection; fever; body aches; This is a spontaneo...
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Severe vomiting repeatedly the night/morning after injection; fever; body aches; This is a spontaneous report from a contactable consumer. A 69-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2, lot unknown as unable to locate, via an unspecified route of administration, administered in arm right on 18Feb2021 09:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. Historical vaccine information included BNT162B2, brand Pfizer , dose 1, administered 28Jan2021 13:30 in the right arm. Concomitant medication included escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported; acyclovir [aciclovir] (ACYCLOVIR [ACICLOVIR]) taken for an unspecified indication, start and stop date were not reported; levothyroxine taken for an unspecified indication, start and stop date were not reported; vitamin d3 (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (B12 [CYANOCOBALAMIN]) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. On "19Feb2021 09:00 PM", the patient experienced severe vomiting repeatedly the night/morning after injection. Then 48hrs later (in Feb2021) developed fever and body aches again. No treatment was received. Outcome of the events was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 69 | 2021-03-23 | decreased appetite |
Severe pain in spine, neck, chest, and arm. Started about 10 days after the vaccine. Sore throat, la...
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Severe pain in spine, neck, chest, and arm. Started about 10 days after the vaccine. Sore throat, lack of sleep, and lack of hunger or thirst.
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| 69 | 2021-03-23 | decreased appetite |
Deep bone and muscle aches, severe headache, no appetite, dizzy and disoriented when standing, extre...
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Deep bone and muscle aches, severe headache, no appetite, dizzy and disoriented when standing, extremely tired, all began about 12 hours after injection. Adverse reactions started to subside about 12 hours after onset, and were completely gone after about 36 hours.
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| 69 | 2021-03-23 | gastrointestinal disorder | Severe GI symptoms followed by death |
| 69 | 2021-03-23 | retching |
Took the 1st shot Thurs. Feb 25, no effects, 21 days later took 2nd shot on Thursday 3/18/21. That n...
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Took the 1st shot Thurs. Feb 25, no effects, 21 days later took 2nd shot on Thursday 3/18/21. That night my arm was sore, came down with aches, headache, tiredness, then chills, fever, weakness, dry heaves, light headedness but did not passout. Stayed in bed for two days, Friday n Saturday. Got up Sunday layed around all day. Got up Monday, Tuesday and today, Wednesday the 24th with headache and feelilng blah, no energy. Vaccine site still slightly sore and itches too. still not feeling myself, today is Wed. Mar 24. May not have any bearing on vaccine but too much of a coincidence.
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| 69 | 2021-03-23 | vomiting, diarrhea | 104.5 temperature Dizzy exhausted Body aches vomiting Severe diarrhea Headache |
| 69 | 2021-03-24 | abdominal discomfort, nausea | Searing headache, upset stomach, mild nausea. |
| 69 | 2021-03-24 | decreased appetite |
Fever, muscle and joint aches, eyeball aches, loss of appetite, extreme fatigue. On the first day af...
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Fever, muscle and joint aches, eyeball aches, loss of appetite, extreme fatigue. On the first day after the second dose (Tuesday, March 16, 2021), I slept 19 hours, sat up for 1 hour, and went back to bed and slept another 16 hours. Upon waking on the second day after the vaccination (Wednesday, March 17, 2021), the fever had broken and the aches were not as severe but still present. No food or drink were consumed as I slept the entire time. On the third day after the vaccination (Thursday, March 18, 2021), aches were gone, but I was so weak with little energy. In addition, I had lost 3.5 pounds since the day of the vaccination. I could not find a thermometer (as well as was too tired to look), so I cannot tell you what my temperature was, but my face/forehead was hot to the touch.
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| 69 | 2021-03-24 | nausea | Headache,chills, joint pain, fatigue, injection site pain, nausea |
| 69 | 2021-03-25 | nausea, decreased appetite |
Saturday Night, I felt nauseated and tried to eat a cracker. I was dizzy and almost passed out. S...
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Saturday Night, I felt nauseated and tried to eat a cracker. I was dizzy and almost passed out. Sunday and Monday, had no appetite, weak, No energy. Tuesday, felt fine.
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| 69 | 2021-03-25 | nausea |
patient states at about 15 mins after receiving vaccine she became lightheaded. Patient was evaluat...
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patient states at about 15 mins after receiving vaccine she became lightheaded. Patient was evaluated by RN vitals taken 110/68 P 80 SPO2 98 RA. Radial pulse regular. Vitals repeated 110/70 P 82 SPO2 98% Patient also c/o of nausea and skin was clammy. No temp noted. Patient was given ice pack to back of neck. States no improvement in symptoms Was evaluated and then transfered over to Urgent Care facility in same building
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| 69 | 2021-03-25 | vomiting | headache, vomiting |
| 69 | 2021-03-26 | decreased appetite |
Fever (afternoon and evening), chills (middle of the night until mid-morning), headache (2 days), fa...
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Fever (afternoon and evening), chills (middle of the night until mid-morning), headache (2 days), fatigue/sleepiness (2 days), loss of appetite (2 days).
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| 69 | 2021-03-26 | nausea | Nausea and muscle pain in right shoulder |
| 69 | 2021-03-27 | nausea |
I;30 am--chills, fever, severe headache, body / joint aches.... 5:30 am-added nausea to above conti...
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I;30 am--chills, fever, severe headache, body / joint aches.... 5:30 am-added nausea to above continued all of 3/24--fever broke 3/25 @4:00am , then other gone with tiredness for rest of day 3/26--okay-back to normal, just little tired
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| 69 | 2021-03-27 | retching, nausea |
mild nausea; Syncope (2x) w/mild seizure; Syncope (2x) w/mild seizure; Flu-like symptoms; chills; jo...
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mild nausea; Syncope (2x) w/mild seizure; Syncope (2x) w/mild seizure; Flu-like symptoms; chills; joint/muscle pain; joint/muscle pain; injection site pain; headache; labored breathing; dry-heaving after second syncope; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old female patient, not pregnant, received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: LOT 6205 (as reported)), via an unspecified route of administration in the right arm, on 08Mar2021, at a single dose, for covid-19 immunization. The patient has no medical history and has no known allergies. Concomitant medications included sertraline; docusate sodium, ferrous fumarate (FERRO-SEQUELS); and multivitamin - all taken for unspecified indications, start and stop dates were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6201) on 15Feb2021 17:00 in the right arm for covid-19 immunization at 69-years-old. The patient did not have covid prior vaccination. The patient did not receive any other vaccines in four weeks. The vaccine was given at the public health clinic. The following day on 09Mar2021 15:30 after a short walk, the patient experienced flu-like symptoms, chills, joint/muscle pain, injection site pain, headache, syncope (2x) with mild seizure, labored breathing, and dry-heaving after second syncope. The patient was then taken by ambulance to the ER (resulted in an emergency room visit) and was given saline fluids via IV. The vitals and EKG were "ok" on 09Mar2021. The patient recovered relatively quickly and was released. The only symptoms remaining on 11Mar2021 were mild headache and mild nausea. The patient had not recovered from headache and nausea at the time of the report; while recovered outcomes on Mar2021 for all the other remaining adverse events. The patient was not covid-tested post-vaccination.
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| 69 | 2021-03-28 | abdominal pain lower, constipation |
03/23/21: Patient presented and was admitted through the ED forof breath that has been present for a...
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03/23/21: Patient presented and was admitted through the ED forof breath that has been present for a week, getting worse with productive cough of whitish sputum's but in large amounts throughout the day. PMH significant to COPD. Stated she is been doing her neb treatments without improvement. Has had some constipation and left lower quadrant abdominal pain. on day of admission, chest x-ray showed bibasilar atelectasis with possible pneumonia. Rapid Covid 19 came back positive. Her D-dimer was elevated. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.
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| 69 | 2021-03-29 | nausea |
slight headache; extremely dizzy; joints ached; nauseated; felt really weak; This is a spontaneous r...
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slight headache; extremely dizzy; joints ached; nauseated; felt really weak; This is a spontaneous report from a contactable nurse (patient). This non-pregnant 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6202) via an unspecified route of administration in the left arm on 23Feb2021 at 07:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, COVID-19, tape allergy, and osteoarthritis all from unknown dates and unknown if ongoing. The patient reported taking concomitant medications. The patient previously received nubain for an unknown indication and experienced allergy, codeine for an unknown indication and experienced allergy, oseltamivir phosphate (TAMIFLU) for an unknown indication and experienced allergy, and amoxicillin sodium; clavulanate potassium (AUGMENTIN) for an unknown indication and experienced allergy.The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 23Feb2021 after receiving her injection, she went home and in a little while she had a slight headache. She took a muscle relaxer and went to bed around 11:30. When the patient got up to go to the bathroom, she was extremely dizzy, her joints ached, she was nauseated and felt really weak. The events were reported as non-serious and did not require hospitalization. The clinical outcomes of slight headache, extremely dizzy, joints ached, nauseated and felt really weak were recovering. It was also reported that since vaccination the patient had not been tested for COVID-19.
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| 69 | 2021-03-29 | vomiting, diarrhea |
Vertigo, loss of consciousness, vomiting, diarrhea, sweats, inability to control limbs to stand or w...
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Vertigo, loss of consciousness, vomiting, diarrhea, sweats, inability to control limbs to stand or walk, altered vision (white picasso slides),
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| 69 | 2021-03-30 | abdominal discomfort, abdominal pain upper |
she had terrible stomach cramps; stomach upset; tired; low grade fever; flu like symptoms; This is a...
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she had terrible stomach cramps; stomach upset; tired; low grade fever; flu like symptoms; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9262), via an unspecified route of administration, in the left arm on 23Jan2021 at 09:00 (at the age of 69-years-old) as single dose for COVID-19 immunisation. The patient had no medical history and family history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not underwent any lab investigation. Caller, reporting on the BNT162B2 shot and who got the first shot on 23Jan2021 and want to know if any one else has these side effects. After the first vaccine, by Tuesday she was experiencing a low grade fever and flu like symptoms on 25Jan2021. The next day on 26Jan2021 she was better but tired. On the following day she was better. She explained that she knew that was side effects. A week later on 06Feb2021 she had terrible stomach cramps and stomach upset that have lasted for 3 weeks. She explained she was getting better but then after the second dose the events came back in full force. She explained that she has had loose stools and was going all day long to the bathroom. She has never had this problem, actually always has the opposite problem. She wanted to know if we have had any other reports like this. The stomach cramps are almost like mensural cramps all day long. She also has stomach upset and every time she eats, it goes right through her. The patient did not visit to emergency room and physician office. Caller did not mention testing positive for COVID during the call, only that this only happens when she has a virus. The events were assessed as non-serious by the reporter. Outcome of the events low grade fever, tired and flu like symptoms were recovered on 27Jan2021 and not recovered for other events.
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| 69 | 2021-03-30 | vomiting, nausea |
3/17/21: Patient presented and was admitted through ED for N/V. Patient is status post colonoscopy. ...
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3/17/21: Patient presented and was admitted through ED for N/V. Patient is status post colonoscopy. Colonoscopy was uncomplicated with polypectomy. She reports persistent vomiting after an hour since then. Per the EUA, hospitalizations to be reported irrespective of attribution to vaccine.
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| 69 | 2021-04-01 | diarrhea, decreased appetite |
3/13/21 Pt presented to an urgent care with generalized aches, chills, HA, diarrhea and cough. Nasal...
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3/13/21 Pt presented to an urgent care with generalized aches, chills, HA, diarrhea and cough. Nasal swab was positive for SARS-CoV-2 and she was diagnosed with COVID-19. 3/17 She presented to ED w/ cough, HA, weakness and decreased appetite. Room air pulse ox was 88%. She was found to have bilateral infiltrates on CRS and was hyponatremic. She was admitted to the hospital on oxygen and decadron.. On 3/18 she was weaned off oxygen. She was discharged to home on 3/19 to complete a 10 day course of decadron.
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| 69 | 2021-04-03 | nausea, vomiting, abdominal discomfort |
inner ear disorder; debilitating; extreme dizziness; nausea; vomiting; stomach discomfort; slight we...
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inner ear disorder; debilitating; extreme dizziness; nausea; vomiting; stomach discomfort; slight weakness; This is a spontaneous report from a contactable consumer. A 69-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN5318), via an unspecified route of administration, administered in Arm Left on 25Jan2021 13:30 (at the age of 49-years-old) at a single dose for COVID-19 immunization. Medical history included blood pressure, cholesterol and seasonal allergies. Blood pressure and cholesterol controlled by meds. Other medical history included drug hypersensitivity. The patient was known allergies to Codeine, Erythromycin, Septra, Sulfa drugs, Vicodin, Medrol. The patient's concomitant medications were not reported.. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced inner ear disorder, very debilitating, extreme dizziness, nausea, vomiting on 27Jan2021 at 08:30 AM. The patient had inner ear problems before, 5 or 6 in my lifetime. She was still experiencing some stomach discomfort and a slight weakness. She had no idea if her inner ear problems this week are related to the vaccine or not. The outcome of events were recovering.
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| 69 | 2021-04-05 | abdominal pain, nausea |
On 3/24, I woke up nauseous, extremely fatigued, with sore joints, headache, and abdominal pain. A ...
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On 3/24, I woke up nauseous, extremely fatigued, with sore joints, headache, and abdominal pain. A few days later I noticed I had extreme shortness of breath. I went to see my PCP on or about 3/31. He listened to my heart and discovered a rapid heartbeat. He then took an EKG. He wanted to put me on lifetime meds immediately. I was in shock because I truly believe this is a reaction to the COVID vaccine. I have never had arrhythmia. In fact, I had a wellness visit with the Dr. about 3 months previously and all was good. I have been seeing him for four years since I moved. He does not think my new diagnosis is related to a vaccine reaction, but I find it highly suspect that 4 other women in my large circle of friends also have AFIB after 2nd shot. I spent Easter in the ER and they pumped Metoprolol in my bloodstream. I did not stay in the hospital that night. I went to see the Dr. on Monday morning on 4/4. He prescribed Metroprolol 25 mg and Xarelto 20 mg IMMEDIATELY. I picked up the meds and started this regimen. In speaking with other women, I believe this terrible diagnosis is a direct result as a reaction from the vaccine.
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| 69 | 2021-04-06 | diarrhea, vomiting, nausea |
Vertigo; nausea; vomiting; diarrhea; loss of consciousness; inability to control limbs; unable to op...
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Vertigo; nausea; vomiting; diarrhea; loss of consciousness; inability to control limbs; unable to open eyes and focus; unable to open eyes and focus; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (BNT162B2, Solution for injection, lot number: EN6204), via an unspecified route of administration in the Left Arm on 20Mar2021 09:30 AM (received at the age of 69-years-old) at a single dose for COVID-19 immunization. The vaccine was administered at a Pharmacy or Drug Store. The patient did not receive any other vaccine within four weeks prior to receiving BNT162B2. The patient was not pregnant at the time of vaccination. Medical history included diabetes mellitus. She had no known allergies. The patient had no prior history of COVID-19. Concomitant medications included dulaglutide (TRULICITY), insulin degludec (TRESIBA), atorvastatin calcium trihydrate (ATORVASTATIN [ATORVASTATIN CALCIUM TRIHYDRATE]), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), and losartan potassium (LOSARTIN). On 21Mar2021 07:30 AM, the patient experienced vertigo, nausea, vomiting, diarrhea, loss of consciousness, inability to control limbs, unable to open eyes and focus. The reported adverse events resulted in emergency room/department or urgent care and hospitalization. The patient was hospitalized for one day. Therapeutic measures were received as a result of reported adverse events; Medicine for nausea, CT scan, IV. Outcome of the events was recovering. The patient was tested for COVID post vaccination on 21Mar2021 through nasal swab with result of negative.
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| 69 | 2021-04-07 | nausea |
vision loss; Severe Migraine over her right eye; blurriness, can't see out of right eye, very blurry...
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vision loss; Severe Migraine over her right eye; blurriness, can't see out of right eye, very blurry was reported as worsened; Body Aches; Nausea; Chills; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), batch lot number unknown, on 22Mar2021 at 09:15 (at the age of 69-year old) at single dose for COVID-19 Immunization. Relevant medical history was not reported. The patient received first dose of the same vaccine on 01Mar2021, on the left arm. Caller states that she has usually gotten sick with the flu shot. Concomitant medications were not reported. On 22Mar2021 the patient experienced chills. On 23Mar2021 the patient experienced nausea, body aches and severe migraine over her right eye and vision loss. She stated that when she covered her good eye she could not see the couch due to blurriness in the right eye. The patient was treated with ibuprofen and acetaminophen (TYLENOL), used hot packs, cold packs and a hot water bottle.The patient recovered from chills on 23Mar2021, she was recovering from nausea and body aches but was not recovered from severe migraine over right eye and can't see out of right eye, very blurry (reported as worsened). Information about lot/batch number has been requested.
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| 69 | 2021-04-11 | nausea, vomiting |
Initial nausea and vomiting two weeks after administration, followed by progressive dementia-like sy...
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Initial nausea and vomiting two weeks after administration, followed by progressive dementia-like symptoms, including fatigue, muscular weakness and tremor, confusion, memory problems, lack of concentration. Abandonment of previously routine household and personal tasks. Inattentiveness to personal hygiene. Inability to perform previously routine tasks. Notable lack of concern about lost physical and mental capabilities.
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| 69 | 2021-04-12 | abdominal distension, abdominal pain |
Sudden after 19 days of the vaccine severe abdominal pain and facial swelling, abdominal distentio...
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Sudden after 19 days of the vaccine severe abdominal pain and facial swelling, abdominal distention , i noticias facial swelling around parotids and subliminal área, no fever they take me to emergency, the pain was very intente 10/10.
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| 69 | 2021-04-14 | appendicitis, decreased appetite, abdominal pain, abdominal discomfort |
I had the first dose of Pfizer covid-19 vaccine on 02/23/2021. Six days later on3/1/2021 I develope...
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I had the first dose of Pfizer covid-19 vaccine on 02/23/2021. Six days later on3/1/2021 I developed abdominal discomfort over the entire abdomen. It progressed into strong abdominal pain. I didn't have any appetite and could not and did not eat for about 48 hours. On 3/3/2021, the general pain subsided a bit, but the pain at lower right abdomen persisted and got stronger, and I still had no appetite. I called my doctor's office and was advised to go to a healthcare facility where I was diagnosed as having acute appendicitis. I was told to go straight to another healthcare facility where the surgeon performed appendectomy on me. I stayed at the hospital for two nights and was discharged on 3/5/2021.
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| 69 | 2021-04-16 | decreased appetite, diarrhea |
Adverse effects chronology: Mar 25 sore arm only Mar 26 cough, diarrhea, dizziness, fatigue, loss of...
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Adverse effects chronology: Mar 25 sore arm only Mar 26 cough, diarrhea, dizziness, fatigue, loss of appetite Mar 27-30 all symptoms intensified daily, intermittent chills started on 29th Mar 31 all symptoms intensified, started using Albuterol inhaler Apr 1 all symptoms intensified, room spinning dizziness resulted in fall, temperature 99.9F Apr 2 Hospital emergency room, covid tests negative, diagnosis: diverticulitis and pneumonia. 3 intravenous antibiotics started metronidazole, clindamycin, rocephin Apr 3 admitted to hospital floor, continued antibiotics Apr 4 electrolyte infusion series started Apr 5 cough lessening, continued antibiotics and electrolyte infusions Apr 6 covid test negative Apr 7 transferred to rehab facility, continued antibiotics, electrolyte drinks Apr 8-14 antibiotic courses allowed to expire, symptoms improving, appetite returning slowly (lost 15 lbs), negative covid test Apr 15 released to home Apr 16 diarrhea stopped, slight dizziness remains, appetite improving
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| 69 | 2021-04-16 | diarrhea, nausea |
She was so dizzy; Stool black; Explosive bowel movements; hot and cold chills; hot and cold chills; ...
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She was so dizzy; Stool black; Explosive bowel movements; hot and cold chills; hot and cold chills; drenched in sweat; walker to back up in the bed; Nauseous; Sore arm; Slight headache; This is a spontaneous report from a contactable consumer (the patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection; Lot Number: EM9810), on the morning of 16Feb2021 09:58 (at the age of 69-years-old) intramuscularly in the right arm as a single dose for COVID-19 immunization. The patient's medical history included knee replacement surgery years ago, dyslipidemia, depression, insomnia, constipation problems; she was taking clopidogrel (PLAVIX) because she had a hole in her heart last year (2020). This was fixed (on an unspecified date), and she was only taking PLAVIX once a day for one year, which will be until Jul2021; the patient called it a hole in her heart because that was what her heart specialist told her. Concomitant medications included: clopidogrel bisulfate (PLAVIX) taken for hole in heart from Aug2020 and ongoing, venlafaxine hydrochloride (EFEXOR), simvastatin (ZOCOR), and temazepam. The patient had an allergic reaction to sulfamethoxazole/ trimethoprim (BACTRIM), and she was also allergic to hydrocodone bitartrate/ paracetamol (VICODIN). On 17Feb2021, had a slight headache and a sore arm. On Friday, 19Feb2021, she woke up very nauseous to her stomach; no treatment received. The patient had hot and cold chills really bad. Her head was just drenched in sweat and this occurred all day long. When she did go to use the restroom and had a bowel movement, her stool was black. It was like black tar around 10:00 or 11pm, it was bad. Every time she sat down to use the bathroom, the sweating would get more intense and every time she would get up and use the restroom, she had to use a walker. Then, she used the walker to back up in the bed (19Feb2021), and she seemed to be okay. It seemed like the sweats would go away and she would get the cold chills. The patient just put a heating pad on her stomach, and this occurred all day long until Saturday morning. She mentions she does have constipation problems, but this was explosive. She couldn't get to the restroom a few times. She had several explosive bowel movements on 19Feb2021 10:00. Her husband brought the garbage pail in the bedroom and she did use plastic on the bedding. By 11:30-12pm on Saturday (20Feb2021), it completely stopped, but she was still sweating. She was so dizzy. It would hit her so bad and her head as wringing wet. However, when she would get back in the bed and lay down flat, the sweating would go away, and she would start to get the cold chills. The patient explained the sweating/hot and cold chills went away by yesterday afternoon (unspecified date). She was able to walk back and forth to the restroom with no problems. She verified all of her symptoms have improved. On 02Apr2021, the patient reported she received the second dose of the vaccine on 09Mar2021. The patient reported that sore arm and chills were important medical events, for which no treatment was received. Treatment received for diarrhea included "limgen". The outcome of explosive bowel movements and stool black was recovered on 20Feb2021, and the other events recovered on an unspecified date. Follow-up (02Apr2021): New information received from a contactable consumer includes: medical history, product data, concomitant medications, and event details. Case upgraded to serious. Follow-up attempts are completed. No further information is expected.
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| 69 | 2021-04-20 | decreased appetite |
This 69 year old female received the Covid shot on 3/10/21 and went to the ED on 3/14/21 and...
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This 69 year old female received the Covid shot on 3/10/21 and went to the ED on 3/14/21 and was admitted on 3/14/21 with weakness, lack of appetite, malignant neoplasm of brain and lung and died on 4/18/21. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.
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| 69 | 2021-04-24 | vomiting, decreased appetite, nausea, diarrhea |
she has been sick as a dog; stool green; bleeding from the bowels; internal and external hemorrhoids...
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she has been sick as a dog; stool green; bleeding from the bowels; internal and external hemorrhoids; nausea and vomitting; nausea and vomitting; no appetite and weight loss; no appetite and weight loss; loose bowels; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the second dose of bnt162b2 (BNT162B2) at the age of 69 years, via an unspecified route of administration on 26Mar2021 (Batch/Lot Number: ER8727) as a single dose for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient received the first dose of BNT162B2 (lot: EN6205) on 05Mar2021 at the age of 69, for Covid-19 immunisation and experienced not feeling good. The patient experienced loose bowels on 26Mar2021; bleeding from the bowels, internal and external hemorrhoids, nausea and vomiting, no appetite and weight loss on 07Apr2021; and she has been sick as a dog on an unspecified date. The patient further reported that she has been sick as a dog, clarifies this started after her second dose of the Pfizer Covid vaccine. Stated she was given some medication to help stop her loose bowels, called dipheni-atrop, 2.5mg, states to take it for three days as needed for loose stool four times a day, started the medication on 30Mar2021 but stopped taking it because it was not doing any good. The patient has lost 7lb. The patient was taking iron and was turning stool green, it bothered her to see the stool green, so she stopped taking it too. Last night the patient drank two sips of soft drink and ate a cucumber and a cup of soup and just sat down and started vomiting. States after the second dose this started, the nausea and vomiting, no appetite, lost weight, loose stools, hemmorhoids internal and external, bleeding in the stool. States doctor wanted a stool sample but she has not been able to get one. The outcome of the event bleeding from the bowels was recovering, she has been sick as a dog was unknown and not recovered from all the other events.
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| 69 | 2021-04-26 | nausea |
(Pfizer shot #2)? serious flu like symptoms including full body aches requiring pain pills for relie...
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(Pfizer shot #2)? serious flu like symptoms including full body aches requiring pain pills for relief, chills, severe headache, and sudden onset of lightheadedness accompanied by nausea . Felt like I was going to pass out and throw up simultaneously. Symptoms persisted for approximately 36 hours requiring me to miss work for two days.
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| 69 | 2021-04-30 | diarrhea, decreased appetite |
This is a spontaneous report from a contactable pharmacist (patient). A non-pregnant 69-year-old fem...
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This is a spontaneous report from a contactable pharmacist (patient). A non-pregnant 69-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 24Mar2021 at 15:30 (at the age of 69 years old) (Lot Number: ER8732, unknown expiration) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, asthma, hypertension, penicillin allergy, and sulfonamide allergy. Concomitant medications included etanercept (ENBREL) from an unspecified start date to 21Mar2021; prednisone; and unspecified blood pressure medication. The patient also received first dose of BNT162B2 for COVID-19 immunisation in left arm on 03Mar2021 at 15:00 (at the age of 69 years old) (lot number: EN6199, unknown expiration). On 25Mar2021, the patient experienced sore arm. On 26Mar2021 at 12:00 PM, the patient had cough, diarrhea, dizziness, fatigue, and loss of appetite. From 27 to 30Mar2021, all symptoms intensified daily and had intermittent chills on 29Mar2021. On 31Mar2021, all symptoms intensified, started using Albuterol inhaler. On 01Apr2021, all symptoms intensified, the patient experienced room spinning dizziness resulted in fall and had temperature 99.9F. On 02Apr2021, the patient visited (hospital name withheld) emergency room, COVID tests negative (Nasal Swab), diagnosis: diverticulitis and pneumonia. Three intravenous antibiotics started metronidazole, clindamycin, and Rocephin. On 03Apr2021, the patient was admitted to hospital with continued antibiotics. On 04Apr2021, electrolyte infusion series started. On 05Apr2021, cough lessening, continued antibiotics and electrolyte infusions. On 06Apr2021, the patient had COVID test negative (Nasal Swab). On 07Apr2021, the patient was transferred to rehab facility with continued antibiotics and electrolyte drinks. From 08 to 14Apr2021, antibiotic courses allowed to expire, symptoms improving, appetite returning slowly (lost 15 lbs; started in Apr2021), negative COVID test (Nasal Swab). On 15Apr2021, the patient was released to home. On 16Apr2021, the patient's diarrhea stopped, slight dizziness remains, appetite improving. The patient did not receive other vaccine in four weeks. The patient has no COVID prior to vaccination. The patient received metronidazole, clindamycin, rocephin, electrolytes as treatment for the events. The events resulted in emergency room/department or urgent care visit. The patient was recovering from events diverticulitis, pneumonia, sore arm, cough, dizziness/room spinning dizziness, fatigue, loss of appetite, intermittent chills, fall, and temperature 99.9F. Outcome of lost 15 lbs was unknown. The patient recovered from diarrhea on 16Apr2021. The events diverticulitis, pneumonia, sore arm, cough, diarrhea, dizziness/room spinning dizziness, fatigue, loss of appetite, intermittent chills, fall, and temperature 99.9F assessed as serious (hospitalization) for 6 days. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 69 | 2021-05-10 | diarrhea | cardiac arrest |
| 70 | 2021-01-04 | nausea |
Persistent headache/ felt very sick with headache on and off; I had body ache; Nausea; Dizzy; I was ...
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Persistent headache/ felt very sick with headache on and off; I had body ache; Nausea; Dizzy; I was feeling very weird/ felt awful; my arm hurt; This is a spontaneous report from a contactable nurse reporting for herself. A 70-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# EH9899 (as reported: "don't know if it E or and F, looks like EH9899") & Expiry Mar2021, via an unspecified route of administration on 22Dec2020 as a single dose (age at vaccination 70 years old), for COVID-19 immunization. Medical history included pulmonary hypertension. The patient's concomitant medications were not reported. The patient had a persistent headache that doesn't go away, and had body ache (onset 23Dec2020). She reported feeling "like I had COVID." She went and got tested because she was a healthcare worker; her first test was negative (Dec2020) and her second test today (29Dec2020) was negative. She thought because it all started the day after vaccine (23Dec2020), that day she felt very sick with headache on and off, nausea, and was dizzy. She was feeling very weird and her arm hurt and she knew that she was going to have some side effect, so she went to work and took some ibuprofen (MOTRIN) for the pain and that was it. She took the vaccine on Tuesday, Wednesday she felt awful, Thursday, the only thing she had was pain in arm that's it but Friday started again with headache and all these symptoms that haven't gone away. The clinical outcome of the event persistent headache, body ache, nausea, dizzy, feeling very weird/ awful was not recovered.
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| 70 | 2021-01-04 | nausea |
sweats; Feeling of unwellness like she had the virus or bad flu; Feeling of unwellness like she had ...
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sweats; Feeling of unwellness like she had the virus or bad flu; Feeling of unwellness like she had the virus or bad flu; could not hardly open eyes/eyes were very heavy; could not hardly open eyes/eyes were very heavy; chills; tiredness; headache; muscle pain; weakness; Joint pain; Fever; Injection site swelling and redness; Injection site swelling and redness; injection site pain; Nausea; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left upper arm, on 21Dec2020 (at the age of 70-years-old) at a single dose for COVID-19 immunization. Medical history included COVID-19 (lasted 3 weeks), high blood pressure (family history in mother and father), lumpectomy, breast cancer, radiation treatment, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities, diabetes, obesity, fibroid tumors, fibroid tumors surgery, thyroid problem, bone density problem, and lower lobe left of lung piece cut out (not cancer). The patient previously received chemotherapy (MANUFACTURER UNKNOWN) for breast cancer, pethidine hydrochloride (DEMEROL) for post fibroid tumors surgery and experienced swollen hands and arms, influenza vaccine (MANUFACTURER UNKNOWN) in 2020 (usually gets swelling/red arm), and oxycodone hydrochloride;paracetamol (PERCOCET) and experienced feeling sick. Concomitant medications included unspecified medications for high blood pressure, thyroid problem, and bone density problem and unspecified nasal spray, water pill, and vitamins. The patient experienced could not hardly open eyes/eyes were very heavy, chills, tiredness, headache, muscle pain, weakness, joint pain, fever, injection site swelling and redness, injection site pain, nausea, sweats, and feeling of unwellness like she had the virus or bad flu on 22Dec2020. The clinical course was reported as follows: The patient felt fine the day when injection was given, but the next day, it was like she had COVID again. She had COVID 3 months ago and it lasted for 3 weeks. It was the same symptoms she had. She could not open her eyes hardly. They were very heavy. The patient had the chills, temperature, sweats, and injection site pain (the next day). There was also swelling and redness that remained for 6 days. The patient reported that if she still puts her hand on it now, there is some sensitivity. She also had tiredness and headache. The patient reported that she only had each of these symptoms for 24 hours (as reported) and the headache was gradually improved. The patient had muscle pain and weakness. She laid down and all she could do was sleep for 24 hours. The patient had nausea for 4 days. She did not have swollen lymph nodes. The patient underwent lab tests and procedures which included blood pressure: 120/80 on an unspecified date and bone density: unknown results on an unspecified date. The clinical outcome of could not hardly open eyes/eyes were very heavy, chills, tiredness, headache, muscle pain, weakness, joint pain, fever, sweats, and feeling of unwellness like she had the virus or bad flu was recovered on an unspecified date, nausea was recovered on 26Dec2020, and injection site swelling and redness and injection site pain was recovered on 28Dec2020. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
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| 70 | 2021-01-05 | vomiting |
severe headache, dizziness, vomiting, elevated bp, turned pale, legs shaking scratchy throat, rash ...
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severe headache, dizziness, vomiting, elevated bp, turned pale, legs shaking scratchy throat, rash to face and throat,
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| 70 | 2021-01-06 | nausea |
Was referred by Dr for evaluation of reaction to first COVID vaccine. First vaccine on 12/21/2020 Pf...
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Was referred by Dr for evaluation of reaction to first COVID vaccine. First vaccine on 12/21/2020 Pfizer-BioNTech. Administered by her place of work. Vaccine was administered in left arm. Had same symptoms as when she had COVID in 10/2020 these symptoms lasted for 12 hours. Started the following day 24 hours after vaccine administration. Symptoms include injection site redness for 6 days, tiredness, headache, muscle pain, chills, joint pain, fever, nausea, and overall feeling of un wellness lasting 12 hours. First symptoms was eyelid heaviness and weakness. No treatment, symptoms resolved on their own. Second vaccine due 1/11/2021. Was covid positive 10/2020- no appetite, aches, chills, sweating, weakness, heavy eyelids, fatigue, ongoing for 3 weeks. Has had difficulty in the past to flu vaccines with local injection site reactions. 09/2020 flu vaccine no symptoms. Has had pneumonia vaccine with no difficulties. Has not received shines vaccine yet.
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| 70 | 2021-01-07 | nausea |
She verbalize she develop headache, nausea, dizziness. She was evaluated onsite by Rescue and relea...
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She verbalize she develop headache, nausea, dizziness. She was evaluated onsite by Rescue and released home feeling better at 10:25 am.
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| 70 | 2021-01-10 | nausea, abdominal pain upper | Stomach cramps/nausea |
| 70 | 2021-01-16 | vomiting, nausea | Severe headaches, nausea, vomiting, swelling of face and throat |
| 70 | 2021-01-17 | nausea |
Pfizer-Biotech COVID-19 Vaccine EUA Patient experienced nausea 30 minutes post vaccine administratio...
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Pfizer-Biotech COVID-19 Vaccine EUA Patient experienced nausea 30 minutes post vaccine administration. Patient states feeling better 10 minutes later.
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| 70 | 2021-01-17 | vomiting | dizzy, wobbling side to side, severe headache, sweating, vomiting. |
| 70 | 2021-01-18 | nausea, diarrhea |
Received first COVID vaccine at 4:30 on Monday, 1/11; Morning of 1/12 had expected symptoms of heada...
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Received first COVID vaccine at 4:30 on Monday, 1/11; Morning of 1/12 had expected symptoms of headache, chills, tiredness; Evening of 1/12 at about 6:30 pm diarrhea approximately 5 - 6 times and febrile about 99.3 (normal temp is around 96.8 - 97.4); Night of 1/12 about 11:00 pm got very dizzy, bad nausea, headache worse and this continued until about 3:30 - 4:30 am on 1/13; day of 1/13 chills and headache continued throughout day, lessening by early evening; Evening of 1/13, about 8:00 pm developed rash on head, face, neck and chest and took a Benadryl, which knocked me out and given no sleep the night before, I slept until noon of Thursday and returned to what I consider full health by 4:00 pm, about 72 hours after receiving the shot.
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| 70 | 2021-01-18 | nausea | Developed a severe headache followed about 24 hours later by nausea |
| 70 | 2021-01-20 | abdominal discomfort |
Trouble sleeping, body aches, stomach upset, extreme fatigue. All symptoms cleared up by 1/21/20...
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Trouble sleeping, body aches, stomach upset, extreme fatigue. All symptoms cleared up by 1/21/2021.
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| 70 | 2021-01-20 | abdominal pain, nausea |
Strong chills; Bad headache; Very painful abdominal cramping; Heavy salivating; Nausea/going to vomi...
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Strong chills; Bad headache; Very painful abdominal cramping; Heavy salivating; Nausea/going to vomit; Both hands went numb with pins and needles; Both hands went numb with pins and needles; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL1284), via an unspecified route of administration from 08Jan2021 09:00 at SINGLE DOSE at right arm for COVID-19 immunization. Medical history included known allergies: latex, high blood pressure, hypothyroidism, and mitral valve prolapse. There were no concomitant medications. At 11am, 2 hours after receiving the first COVID19 vaccine, my reactions occurred simultaneously. The patient experienced Strong chills, Bad headache, Abdominal Very painful abdominal cramping, Heavy salivating, Nausea, Both hands went numb with pins and needles, the patient felt like she was either going to vomit or have a bowel movement, ultimately it was the latter. This is when both her hands went numb. These reactions lasted 15-20 minutes and then dissipated with the exception of a lingering less painful headache through Friday and Saturday. The patient did not receive treatment for the events. The outcome of the events was recovered.
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| 70 | 2021-01-20 | nausea |
Headache with burning lips burning and stinging in right side of face with slight swelling. Pulsati...
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Headache with burning lips burning and stinging in right side of face with slight swelling. Pulsating area below lip on right side of face. Pulsation visable when looking at face. On the first day, Jan 19, 21. Nausea,dizzyness and off balance,headache. Second day 1/22/21 just general unwell feeling all day with headache.
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| 70 | 2021-01-20 | nausea |
tightness of shoulders and neck; tightness of shoulders and neck; started having severe nausea in th...
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tightness of shoulders and neck; tightness of shoulders and neck; started having severe nausea in the last hour; Has a slight headache; This is a spontaneous report from a contactable consumer (patient herself). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 08:00 in left arm at single dose for covid-19 immunization. Medical history included ongoing diabetes (she had it for 20 years), ongoing asthma (she had it for 25 years), ongoing cirrhosis of the liver non alcoholi diagnosed two years ago, ongoing hypertension diagnosed in the last three months, ongoing fatty liver diagnosed two years ago. There were no concomitant medications. Patient had Covid vaccine this morning at 8 am (12Jan2021) that was fine after 15 minutes, but patient started having severe nausea in the last hour and was unresolved by her nausea medicine. Patient had a slight headache. Patient stated that the headache which was mild, tightness of shoulders and neck started at 13:30. Patient stated that she took acetaminophen 1000 units and used a heating pad for the shoulder. Outcome of nausea was not recovered, and outcome of events were recovered on 12Jan2021. Information on the lot/batch number has been requested.
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| 70 | 2021-01-21 | nausea, decreased appetite |
Headache and achy feeling that night. Next day headache progressively got worse, queasy went to ful...
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Headache and achy feeling that night. Next day headache progressively got worse, queasy went to full nausea, trouble eating anything because of the nausea, aches in every joint, temperature reached 100.2 before going to bed (I almost never hit 97.2), chills. Thursday, still have milder headache, still achy all over, arms just feel heavy, temp still at 98.9. Friday, still have headache and loss of appetite, but much better
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| 70 | 2021-01-21 | nausea |
Headache, Fever, Chills, Nausea, Body Aches. Restless. Worst symptoms lasted 24 hours. The next 24 h...
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Headache, Fever, Chills, Nausea, Body Aches. Restless. Worst symptoms lasted 24 hours. The next 24 hours was lingering headache, fatigue, but improved from day before.
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| 70 | 2021-01-25 | indigestion, vomiting, nausea, abdominal pain |
Cough fever chills then on 1/22/2021 coughs fever chills severe abdominal pain nausea vomiting indi...
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Cough fever chills then on 1/22/2021 coughs fever chills severe abdominal pain nausea vomiting indigestion
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| 70 | 2021-01-26 | decreased appetite | extreme fatigue, headache, loss of appetite lasted 24 hours |
| 70 | 2021-01-26 | nausea |
Severe dizziness; Nausea; This is a spontaneous report from a contactable consumer (patient) reporte...
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Severe dizziness; Nausea; This is a spontaneous report from a contactable consumer (patient) reported a 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not reported), via an unspecified route of administration from an unspecified date, at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient is not pregnant at the time of vaccination. No allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Jan2021 at 14:30, the patient experienced severe dizziness and nausea. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovering. The reporter assessed the events as non-serious. Information on the lot/batch number has been requested.
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| 70 | 2021-01-28 | diarrhea |
Body ache; diarrhea; Headache; Elevated temperature; This is a spontaneous report from a contactable...
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Body ache; diarrhea; Headache; Elevated temperature; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3302), via an unspecified route of administration in the left arm, on 14Jan2021 at 09:00 (at the age of 70-years-old) at a single dose for COVID-19 immunization. Medical history included heart disease and high blood pressure (HBP). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medications, taken within two weeks of vaccination, included acetylsalicylic acid, clopidogrel (PLAVIX PLUS). Other concomitant medications included unspecified blood pressure medication, unspecified cholesterol medication, and unspecified thyroid medication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced body ache, diarrhea, headache, and elevated temperature on 15Jan2021 at 14:00. The events were reported as non-serious. The patient underwent lab tests and procedures which included body temperature: elevated on 15Jan2021. The patient did not receive any treatment for the events. The clinical outcome of body ache, diarrhea, headache, and elevated temperature was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 70 | 2021-01-29 | diarrhea, nausea |
Day 1 & 2 irritability and depression Day 3 nausea, fever, chills & diarrhea - really felt bad, bu...
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Day 1 & 2 irritability and depression Day 3 nausea, fever, chills & diarrhea - really felt bad, but no vomiting. Was able to eat. Day 4 (today) fever, chills and diarrhea - feel a little better than yesterday. Still able to eat ok. I have not contacted my healthcare provider about these symptoms because it is the weekend. If I still have symptoms on Monday, I will call him. In the meantime I?m taking Tylenol for the fever and drinking water to stay hydrated.
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| 70 | 2021-01-29 | nausea |
Acute fainting episode during the night following the day of the vaccine. Hit my head on the stone ...
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Acute fainting episode during the night following the day of the vaccine. Hit my head on the stone floor and was unconscious. Taken to ER in ambulance. All diagnostics were normal and after blood pressure returned to normal and getting 4 staples in my scalp I was released. Since coming home I have been very ill with weakness, vertigo, nausea, and headache.
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| 70 | 2021-01-30 | abdominal pain upper, nausea, retching | Stomach ache, nausea, dry heaves, headache fever(101.3) chills body aches, headache, brain fog |
| 70 | 2021-01-30 | gastrointestinal pain |
1/27/2021 and 1/30/2021chills and headache @ noon on. 1/30/2021 also had gut cramping. 1/27/2021 thr...
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1/27/2021 and 1/30/2021chills and headache @ noon on. 1/30/2021 also had gut cramping. 1/27/2021 through 1/30/2021 I was also very tired and napped for hours. I slept and covered up and the chills and headache abated.
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| 70 | 2021-01-30 | nausea |
12:25 Slight dizziness with an overall hot feeling for @12min, then 2 hours later chills and slight ...
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12:25 Slight dizziness with an overall hot feeling for @12min, then 2 hours later chills and slight feverish feeling slight nausea,, which lasted ...then just turned into flu like feeling...insomnia with body feeling slightly jittery till 4am ,took nighttime cold tablet. Flu like symptoms till 31st am.
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| 70 | 2021-01-30 | vomiting | Chills, vomiting, headache after 30 hours of receiving COVID-19 Vaccine |
| 70 | 2021-01-30 | vomiting | At around 09:30 am I was feverish, tired and sick at my stomach and vomited twice. |
| 70 | 2021-02-01 | decreased appetite |
I have been having symptoms for 6 days now. Feeling very parched, especially after eating Feeling as...
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I have been having symptoms for 6 days now. Feeling very parched, especially after eating Feeling as if I were mildly allergic to what I had eaten and having the impression that upper palate was a little swollen, even if it wasn't. Mouth and upper palate always feels funny after eating making me not wanting to eat much Chalky mouth Mucous in the throat and mouth today Chills, muscle soreness, loss of appetite yesterday
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| 70 | 2021-02-01 | diarrhea |
Duration of diarrhea following first dose of vaccine on 16Jan2021; This is a spontaneous report from...
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Duration of diarrhea following first dose of vaccine on 16Jan2021; This is a spontaneous report from a non-contactable consumer (patient). A 70-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient called and asked about duration of diarrhea following first dose of vaccine on 16Jan2021. Outcome of the event was unknown. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
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| 70 | 2021-02-02 | abdominal discomfort |
Sneezing, congestion, headache, pain at injection site. Slight upset stomach. Have taken acetaminop...
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Sneezing, congestion, headache, pain at injection site. Slight upset stomach. Have taken acetaminophen and Sudafed.
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| 70 | 2021-02-03 | gastrointestinal pain |
Intestine discomfort, multiple bowel movements (no diarrhea), chills, feverish (but no fever), muscl...
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Intestine discomfort, multiple bowel movements (no diarrhea), chills, feverish (but no fever), muscle aches. I'm reporting this 24 hours after getting the 2nd Pfizer shot. Reaction started overnight. Don't know at this time how long this will last. Have not called doctor. Taking Tylenol.
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| 70 | 2021-02-03 | vomiting, decreased appetite, GERD |
bad chills/terrible chills; terrible acid reflux for 3 hours; couldn't even walk, she had to crawl a...
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bad chills/terrible chills; terrible acid reflux for 3 hours; couldn't even walk, she had to crawl and her husband had to walk her around, she couldn't do anything; threw up; very dizzy/dizziness; vertigo; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982, unknown expiration), via injection in right arm on 13Jan2021 at a single dose for COVID-19 prevention. Medical history included ongoing vertigo (in car accident a little over 5 years ago, that affected a big nerve in left temple, and so every once in a while she will get vertigo so bad that she falls over), ongoing GERD (from a hiatal hernia; diagnosed many years ago), ongoing high blood pressure diagnosed about 15 years ago, ongoing bad cholesterol diagnosed 10 to 15 years ago, ongoing heart burn, ongoing hiatus hernia, and car accident a little over 5 years ago. Concomitant medications included ongoing omeprazole sodium (OMEPRAZOLE) for GERD, heart burn, and hiatal hernia (started this product at least 10 years ago; takes the product as needed if she is having heart burn or is going to eat spicy food); ongoing vitamin D3 for vitamin supplementation (started product about 8 months ago, because her doctor told her too, she guesses her vitamin was low); ongoing metoprolol for high blood pressure and to prevent stroke (started product at least 15 years ago; her BP could be regular but it could shoot up when she is upset, so she takes this to prevent stroke); ongoing hydrochlorothiazide for blood pressure (started product at least 5 years ago); pravastatin for bad cholesterol (started the product at least 4 or 5 or more years ago); and ongoing acetylsalicylic acid (BABY ASPIRIN) to prevent stroke (has been taking this product forever, at least for 10 years). The patient reported that she received the first COVID shot on 13Jan2021. She was okay on the 13th, 14th, and 15th. However, on the 16th (16Jan2021), she woke up and threw up once and was very dizzy for three days. She mentioned that she had like vertigo, she couldn't even walk, she had to crawl and her husband had to walk her around, she couldn't do anything. She had vertigo (16Jan2021). She was that way on Saturday and Sunday. On Monday, the patient's son took her to acupuncturist for her dizziness and was able to get up fine and walked away. After the acupuncture, she felt fine, like she was all better. On 19Jan2021 (reported as yesterday), she was fine. She woke up at midnight and had terrible acid reflux for 3 hours even though she had hardly eaten. She does take omeprazole for heart burn, and she had taken omeprazole earlier in the day, but it was just coming up, that acid and burning. She drank milk to coat the stomach and it went away at 03:00 AM. She had very bad chills/terrible chills (20Jan2021) and her teeth were chattering, she couldn't even talk, and couldn't control the chills. She is fine now. She clarified that she got vertigo from a car crash years ago and haven't had it in almost a year. Chills are not ongoing at this time, she has not had any for about 4 hours now, and she is hoping she is recovered completely, but it may be too soon to tell. She did not receive other vaccines on the same day as the COVID vaccine. The patient is wondering if all this could be from the vaccine. The patient wanted to know if it is safe to take the second shot. She was scheduled to receive the second dose on 03Feb2021. The patient recovered from the events threw up on 16Jan2021; unable to walk and vertigo on 18Jan2021; dizziness on 19Jan2021; and terrible acid reflux on 20Jan2021. While unknown outcome for chills.
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| 70 | 2021-02-04 | diarrhea |
Fever 101 for two days. Chills sweats muscle aches and joint pain, headache, fatigue dizziness weakn...
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Fever 101 for two days. Chills sweats muscle aches and joint pain, headache, fatigue dizziness weakness, diarrhea . Had Weakness for two more days.
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| 70 | 2021-02-04 | difficulty swallowing |
swelling of tongue and mouth; swelling of tongue and mouth; Trouble swallowing normally; dizzy; seei...
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swelling of tongue and mouth; swelling of tongue and mouth; Trouble swallowing normally; dizzy; seeing stars; This is a spontaneous report from a contactable consumer (the patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL8982), via an unspecified route of administration in the left arm on 21Jan2021 (at the age of 70-years-old) as a single dose for COVID-19 immunization. Medical history included allergies when growing up: food allergies, allergic to pollens, allergic to iodine. The patient took allergy shots for years. The patient did not have trouble very often anymore. The patient stated she was healthy. The patient did not have COVID prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included: clarithromycin (CLARITIN). The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 21Jan2021, the patient experienced a little swelling of tongue and mouth, trouble swallowing normally, and dizzy and seeing stars. For treatment of these events, the patient took diphenhydramine hydrochloride (BENADRYL). The clinical outcome a little swelling of tongue and mouth, trouble swallowing normally, and dizzy and seeing stars was recovered on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 70 | 2021-02-04 | nausea |
Symptoms of Vertigo- lightheaded, balance issues, nausea, feeling like on the verge of full blown Ve...
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Symptoms of Vertigo- lightheaded, balance issues, nausea, feeling like on the verge of full blown Vertigo attack
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| 70 | 2021-02-05 | nausea |
2/5/21 2nd Pfizer COVID vaccination ~1050. Began to feel nauseous, headache, increased BP. She had...
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2/5/21 2nd Pfizer COVID vaccination ~1050. Began to feel nauseous, headache, increased BP. She had these symptoms with 1st dose also. Was given acetaminophen 500mg po x 1 at 1100. During observation the headache began to resolve. Tends to get nauseated/car sickness and is currently on Prilosec. Placed on pulse oximeter and vital signs monitored. Symptoms are resolving during observation period and a friend is picking her up so she does not need to drive and friend will observe her the rest of the day.
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| 70 | 2021-02-05 | nausea |
My reaction began typically enough, with a sore arm and chills. The chills subsided by the evening,...
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My reaction began typically enough, with a sore arm and chills. The chills subsided by the evening, but symptoms continued and migrated from there. The arm remained sore for 3 days and then began to itch. This itchiness continued on and off for the next 2 days. My neck and shoulder were also sore. The shoulder continued to be sore for about 4 days. I had an intermittent headache, also for 4 days. The worst part though, is the nausea, which also comes and goes. But it can last for many hours and now, even after 8 days, I am still experiencing this. I can find nothing in the writings about this vaccine to corroborate this side effect and I am therefore worried about the second shot.
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| 70 | 2021-02-05 | vomiting |
9pm on 2/4/2021 moderate dizzyness; went to bed. Awoke 3AM on 2/5/2021 severe vertigo, unable to foc...
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9pm on 2/4/2021 moderate dizzyness; went to bed. Awoke 3AM on 2/5/2021 severe vertigo, unable to focus my eyes and unable to walk without holding on the wall. Vomited (no blood); called 911. In ER they administered Benedryl and Reglan, NS bolus. Symptoms improved significantly - only slight dizzyness. Emergency Doc Dx: acute vestibular neuronitis. Rx'ed methylPrednisolone, dospak. Symptoms should diminish in next few days. #20 question therefore noted as "Unknown"
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| 70 | 2021-02-06 | decreased appetite | Fever 103, shakes, chills, profound weakness, loss of appetite, high blood sugar |
| 70 | 2021-02-06 | indigestion | Itchy skin on arms and upper back. Red welts Indigestion that lasted 5 hours. |
| 70 | 2021-02-06 | retching, nausea |
after 15 minutes feeling hot, heart beating hard in chest, after 30 minutes dizzyness, lips feeling ...
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after 15 minutes feeling hot, heart beating hard in chest, after 30 minutes dizzyness, lips feeling numb and tingly, was taken to ER as it was part of the same building in a wheel chair, was also anxious, nauseated and had dry heaves and blood pressure was elevated. Received IV solumedrol, ativan and zofran and then later oral benadryl. I was told to contact my PCP to see if I should get the second vaccine and he indicated no.
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| 70 | 2021-02-06 | stomatitis |
On days 4-7 post injection, I experienced facial nerve pain that felt like herpes or shingles includ...
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On days 4-7 post injection, I experienced facial nerve pain that felt like herpes or shingles including ear pain, cheek hypersensitivity, swollen gland in neck, and sores along the bottom left gum line in my mouth. This all occurred on the right side of my face. I did not treat the pain or eruptions in any way except for regular dental care. The symptoms healed/subsided after 5 days . I have a small amount of residual sensation in my jaw near my ear but it is much better.
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| 70 | 2021-02-07 | nausea |
Patient complained of nausea (nervous before vaccine); BP 120/63 (pulse 70), O2 sat 100%. Better aft...
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Patient complained of nausea (nervous before vaccine); BP 120/63 (pulse 70), O2 sat 100%. Better after blood pressure was checked.
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| 70 | 2021-02-08 | vomiting, diarrhea | Vomiting, diarrhea, chills, fog head, tiredness, slight sore arm |
| 70 | 2021-02-09 | abdominal pain upper | Flu like symptoms, sneezing, runny nose, stomach pain and achy all over. Low grade fever one day. |
| 70 | 2021-02-09 | decreased appetite, nausea |
Fever, aching, nausea, loss of appetite, and fatigue. Used 2 Tylenol ES. Nothing really changed. Thi...
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Fever, aching, nausea, loss of appetite, and fatigue. Used 2 Tylenol ES. Nothing really changed. This morning fever was 100.6 F. That has now dropped to normal w/Tylenol. Appetite is coming back.
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| 70 | 2021-02-10 | abdominal pain, nausea, diarrhea |
Body aches, Abdominal pain, diarrhea, nausea, headache, chills, low temp 99.8 Thurs 2/4 & continui...
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Body aches, Abdominal pain, diarrhea, nausea, headache, chills, low temp 99.8 Thurs 2/4 & continuing thru Thurs 2/11
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| 70 | 2021-02-14 | diarrhea |
Explosive Diarrhea, & explosive vomiting lasting over 10 hours. Rapid heart rate which began prior t...
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Explosive Diarrhea, & explosive vomiting lasting over 10 hours. Rapid heart rate which began prior to above diarrhea & vomiting. Muscle cramping & muscle twitching much like electrical shock especially in lower extremities along with severe headache. Low grade fever & mild chills. Extreme tiredness/low energy which still remains. There was also a degree of dizziness which remains as well.
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| 70 | 2021-02-14 | nausea, vomiting, decreased appetite |
Patient reported nausea, vomiting, weakness, chills, unable to keep food down, face broke out in ras...
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Patient reported nausea, vomiting, weakness, chills, unable to keep food down, face broke out in rash around eyes and rash on hand. Patient reported symptoms lasted over a week. Went to ED, given IV fluids and discharged home.
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| 70 | 2021-02-14 | nausea, vomiting |
Night of Feb 13. Felt tired around 10 pm, headed for bed. Lay down and room started spinning. Starte...
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Night of Feb 13. Felt tired around 10 pm, headed for bed. Lay down and room started spinning. Started feeling nauseous. (Note no alcohol consumed since New Year?s.) sat up, read a while, tried lying down again 3 times with same result. Got up to walk, threw up. After about 15 min was able to lie down and sleep. Process took about 2 hours in all. Mild nausea and dizziness continuing to now, Monday afternoon. Note lifelong history of motion sickness related to boats, planes, swaying motions, sometimes car travel.
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| 70 | 2021-02-15 | decreased appetite |
Date and time of vaccination: (list both if they received both shots): 1/12/21 0830; 2/12/21 1500 Br...
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Date and time of vaccination: (list both if they received both shots): 1/12/21 0830; 2/12/21 1500 Brand and lot of vaccine: 1st EL9262 , 2nd EN9581 extreme fatigue, itching underarm of injection site, lightheadedness, poor appetite
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| 70 | 2021-02-16 | nausea |
woke up morning after shot with headache, slight nausea, severe muscle and joint pain and muscle wea...
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woke up morning after shot with headache, slight nausea, severe muscle and joint pain and muscle weakness, could hardly sit up by myself, this was 2/11/21. I continued to feel these symptoms with lessening severity over the next 3 days until Sunday 2/14/21 at which time, late in the afternoon, I fell asleep and woke up drenched in sweat but feeling pretty much back to normal self and have felt normal self since then.
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| 70 | 2021-02-17 | nausea |
Nausea, flushed, dizzy, after about 20 minutes my throat closed, unable to breath. The workers did ...
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Nausea, flushed, dizzy, after about 20 minutes my throat closed, unable to breath. The workers did not know how to use epi-pen. I used my own epi- pen, ENT used heart monitor, intervenious Benadryl was administered, I was transport to ER at hospital, treatment with more meds, prednisone. I was kept in ER for several hours for monitoring. I had no more reaction.Y
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| 70 | 2021-02-18 | diarrhea, flatulence, abdominal discomfort, abdominal distension, vomiting |
I had an upset stomach that felt very gassy and swollen around 4:00 PM, then I began to throw -up ab...
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I had an upset stomach that felt very gassy and swollen around 4:00 PM, then I began to throw -up about 2:00 AM . After I threw -up a lot, diarrhea set in. My stomach is still upset today, but have not thrown up. The last loose bowel movement was around 4:00 AM. this morning.
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| 70 | 2021-02-18 | diarrhea | Chills, joint pain, body aches, syncopal episode, diarrhea, headache, malaise |
| 70 | 2021-02-18 | nausea, retching |
Feeling very hot; lips numb and tingly; lips numb and tingly; headache; dizzy; heart beating hard in...
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Feeling very hot; lips numb and tingly; lips numb and tingly; headache; dizzy; heart beating hard in chest; anxiety; nausea with dry heaves; nausea with dry heaves; elevated blood pressure; This is a spontaneous report from a contactable nurse (self-reported). A 70-year-old female patient (who was not pregnant at the time of vaccine) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; el3249) via an unspecified route of administration, at right arm on 14Jan2021 14:00, at hospital for COVID-19 Immunization. Medical history included HTN (hypertension), GERD (Gastrooesophageal reflux disease), oral cancer 2020 with surgery only, arthritis, hypothryroid and allergies to nickel. Concomitant medications included, irbesartan (AVAPRO), levothyroxine, liothyronine (NP THYROID), lansoprazole (PREVACID), ibuprofen (MOTRIN) and paracetamol (TYLENOL). The patient previously took metoclopramide (REGLAN) and prochlorperazine edisylate (COMPAZINE); patient had allergies to both drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of medications the patient received within 2 weeks of vaccination, included: avapro, np thyroid, prevacid, motrin, Tylenol. On 14Jan2021 at 14:15 (after 15 minutes of dose), the patient experienced feeling very hot, lips numb and tingly, headache, dizzy, heart beating hard in chest, anxiety, waited another 15 minutes, taken to ER (Emergency Room) on site; elevated blood pressure, nausea with dry heaves. Patient was taken into Emergency room/department for urgent care and received treatment IV solumedrol, ativan and zofran, oral Benadryl. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered on an unknown date in 2021; Sender's Comments: There is a reasonable possibility that the events headache and nausea were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the other reported serious events with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 70 | 2021-02-18 | nausea | Nausea, fatigue, soreness |
| 70 | 2021-02-18 | nausea |
Sore arm, headache, nausea, sweats Time: from 7PM (Feb. 17th) until morning of the second day (Feb. ...
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Sore arm, headache, nausea, sweats Time: from 7PM (Feb. 17th) until morning of the second day (Feb. 19th).
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| 70 | 2021-02-19 | nausea | 1) Extreme fatigue; 2) Muscle ache; 3) Fever (101.1); 4) Nausea; 5) Headache. |
| 70 | 2021-02-21 | abdominal discomfort | Fever,chills,upset stomach, body aches,headache |
| 70 | 2021-02-21 | decreased appetite, nausea |
Woke up in middle of night with fever, chills, teeth rattling, nausea, dizziness, weakness. Took ace...
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Woke up in middle of night with fever, chills, teeth rattling, nausea, dizziness, weakness. Took acetaminophen and some anti -nausea drugs I had on hand. Fever left, but returned next night. Weakness, no appetite stayed for two days. Thought it was the flu, but no upper respiratory symptoms. Thought it might be Covid-19 but tested negative. Finally decided it was a reaction to the vaccine.
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| 70 | 2021-02-21 | GERD, nausea, abdominal discomfort, flatulence, decreased appetite |
Felt fine at first, but then suffered flu-like symptoms including extreme fatigue, stomach discomfor...
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Felt fine at first, but then suffered flu-like symptoms including extreme fatigue, stomach discomfort, gas, nausea, loss of appetite, acid reflux. Some symptoms have ceased or lessened, but extreme fatigue, lack of appetite and some stomach discomfort and acid reflux discomfort continues.
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| 70 | 2021-02-21 | nausea, abdominal pain upper |
Approx. 1 hr. & 20 min. post injection, severe reaction: Severe upper abdominal pains, multiple, unc...
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Approx. 1 hr. & 20 min. post injection, severe reaction: Severe upper abdominal pains, multiple, uncontrollable formed to diarrheal bm's triggered vagal response, passed out, severe diaphoresis, violent chilling loss of control of bowel movements. Lasted approx. 30-35 minutes. crawled with head hanging to floor to keep from passing out, to locate a phone for help. after several of agonizing attempts to try and climb up to couch to elevate legs high above head and laying there for approx. 20 or more min. blood pressure came up some. (Did not call emergency services) afraid of hospitalization due to all chronic health problems, (forgot to report earlier that I am Hypothyroid as well) previously hospitalized for a Thyroid Storm. This is day 10 from injection and still have nausea, dizziness & fatigue, (also have couple episodes of abdominal pain). (I want to add that I felt completely fine prior to receiving 2nd Pfizer Covid dose). I am contacting my doctor today to receive some IV fluids.
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| 70 | 2021-02-21 | nausea |
Aside from expected soreness at injection site, no adverse reactions through rest of Feb 10 and a...
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Aside from expected soreness at injection site, no adverse reactions through rest of Feb 10 and all of Feb 11 and 12 Starting February 13 and continuing through today (Feb 22), I have had the following symptoms: Vestibular migraine - very severe at the beginning, receding with time, but still concerning Nausea - on and off for full period, no relation to food intake Fatigue - tired most all of the time, could fall asleep at any time Balance - variable for this period, no falls, but do not feel safe to drive
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| 70 | 2021-02-21 | vomiting | Vomiting 4-5 hours |
| 70 | 2021-02-21 | vomiting |
Hypercalcemia AKI encephalopathy acute vomiting fatigue acute ER 2/15 ICU 2/15 Hospitalized till 2...
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Hypercalcemia AKI encephalopathy acute vomiting fatigue acute ER 2/15 ICU 2/15 Hospitalized till 2/2021 IVs extensive electrolyte medications
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| 70 | 2021-02-22 | decreased appetite, difficulty swallowing, vomiting |
2/7/21 Increased difficulty chewing, swallowing, evaluated by SLP and dietician. Diet texture down-g...
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2/7/21 Increased difficulty chewing, swallowing, evaluated by SLP and dietician. Diet texture down-graded x 2 with poor appetite and recent 6lb weight loss. 2/8/21-APRN updated regarding poor appetite and difficulty chewing as well as downgraded texture of diet. Also informed of increased s/s of discomfort and increased use of PRN Oxycodone for pain. 2/9/21- elevated temp 100.7. 2/9/21 Covid pcr test negative. 2/9/21-N.O.?s APRN BMP, Albumin and Pre-albumin Level in am. 2/11/21-elevated temp 100.4. Covid rapid test negative. 2/12/21- CBG recorded at 517 at 5:20 am. Resident also has an elevated temp of 100.9. Tylenol administered per order. Vital signs include resp 24, radial pulse 134, O2 sat 83%. Supplemental oxygen administered via nasal cannula. Head of bed elevated. DR. notified at time via telephone. Order given for sliding scale for CBG. Guardian updated regarding changes in residents condition, poor prognosis. Guardian requests Hospice eval and admit. Guardian requests comfort care no hospitalization, no IV's, no G-tubes, no labs etc, D/C of Palliative services. ARNP informed. 2/12/21 Acute Telehealth visit with APRN due to increased lethargy, elevated CBG?s despite poor appetite and insulin administration. Resident unresponsive to verbal and noxious stimuli at time of visit. N.O. Morphine sulfate 20mg/ml, give 2.5mg PO/SL Q4hr PRN pain/shortness of breath. 2/12/2021-Admitted to Hospice, Lethargic, diaphoretic, T 98.1 P 130's R 18 O2 high 80's to low 90's via O2 mask at 3L. 2/12/2021- Resident legs and arms noted to feel cool this afternoon, 02 sat was 97% with 02 on @ 3L with mask Noted resident with sob and increased pulse. Prn morphine 0.25ml sl. given with good effect. Resident was less restless and quiet in her bed. Checked on resident several times this shift for needs. Resident noted to not move in her bed @ 8:15pm and noted she was not breathing. Supervisor called and pronounced resident deceased.
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| 70 | 2021-02-22 | diarrhea, nausea, abdominal discomfort |
When I left facility I had a mild headache. After getting on the highway face turned beet red with ...
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When I left facility I had a mild headache. After getting on the highway face turned beet red with mild swelling. Throat felt tight but not closed. An hour later the headache was worse. Took a Tylenol and slept for an hour. Woke up itchy. Glands on right side of neck very sore with pain radiating to base of skull. Swelling in face subsided after a few hours. Later at night I was still itchy with some small red hives on my arms, legs, and stomach. Arm very sore. Woke several times during the night with nausea. Woke up morning of the 20th with mild dizziness, upset stomach and severe diarrhea, Serious headache all day. Hives subsided but was still itchy. On the 21st felt much better but still with diarrhea. Today is the 23rd and no diarrhea since this morning.
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| 70 | 2021-02-22 | diarrhea |
Raised red bumps (size of quarter) on back of forearms. Only one or two bumps, very itchy. Started...
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Raised red bumps (size of quarter) on back of forearms. Only one or two bumps, very itchy. Started on left arm, moved to right arm. Small round raised bumps on lower, inside of left forearm (about 3-4.) Then gastoinstestinal symptoms with diarrhea (second bout more severe.) Subtle red coloration on trunk that when stroked with finders turned white. Trunk itching, genitals itching. Hot burning hands, feeling of unease. The symptoms have lasted for days. Injected on 2/5 still having symptoms on 2/23. Taking Benadryl.
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| 70 | 2021-02-22 | diarrhea | Hives, Diarrhea |
| 70 | 2021-02-22 | nausea |
approx. 5 minutes after receiving the vaccine client started c/o nausea. She was given an antacid an...
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approx. 5 minutes after receiving the vaccine client started c/o nausea. She was given an antacid and it helped. She says by the time she got home she had a Headache that lasted off and on for 3 days. She took Excedrin and it helped.
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| 70 | 2021-02-22 | nausea |
I began getting chills and felt feverish. I also had body aches and pains as when ill with the flu. ...
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I began getting chills and felt feverish. I also had body aches and pains as when ill with the flu. There was a sense of nausea initially but it went away. There was pronounced feeling of heat located subcutaneously on my right outer thigh. It came and went about every minute or so. (I counted the seconds in between each incident). I am still experiencing flu like symptoms (bodily aches, slight headache, mild chest pain, and general ill-feeling.) I will contact my primary care physician today about my concerns but felt it necessary to document these mild but disturbing side effects.
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| 70 | 2021-02-23 | abdominal pain upper, nausea |
nauseous; severe stomach cramps; shortness of breath; chest tightness; diaphoretic; chilled; cold to...
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nauseous; severe stomach cramps; shortness of breath; chest tightness; diaphoretic; chilled; cold to the touch, ashen; cold to the touch, ashen; patient was treated as if a heart attack; This is a spontaneous report from a contactable healthcare professional (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 29Jan2021 15:30 at a single dose for Covid-19 immunization. Medical history included high BP, and cholesterol. Patient had no known allergies. Concomitant medications included amlodipine and simvastatin. The patient experienced nauseous, severe stomach cramps, shortness of breath, chest tightness, diaphoretic, chilled, cold to the touch, ashen on 01Feb2021 at 15:30. Ambulance was called, patient was brought to the ER and was hospitalized on an unknown date for 2 days. Treatment of events: patient was treated as if a heart attack, nitro, baby aspirin. Patient was not diagnosed with Covid-19 prior to vaccination. Patient has not tested positive for Covid-19 after vaccination. Outcome of the events was recovered. Information on lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be completely excluded based on a compatible temporal relation. Case will be re-assess once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 70 | 2021-02-23 | decreased appetite, diarrhea |
Fatigue; Body Aches/Soreness; Chills; Swollen and Sore Tongue; Swollen and Sore Tongue; Diarrhea; Lo...
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Fatigue; Body Aches/Soreness; Chills; Swollen and Sore Tongue; Swollen and Sore Tongue; Diarrhea; Loss of Appetite; Throat swelling; Headache; Malaise; Shortness of Breath; Thick Mucus in Nose & Throat; Thick Mucus in Nose and Throat; Horseness and Sore Throat; Horseness and Sore Throat; This is a spontaneous report from a contactable consumer (patient herself). A 70-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on right arm on31Jan2021 08:30 at single dose for COVID-19 immunisation. Medical history included autoimmune, tachycardia, acid reflux, penicillin allergy, walnuts allergy. Concomitant medication included estradiol and levothyroxine. The patient previously took lanolin and erythromycin and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Feb2021 patient experienced fatigue, body aches/ soreness, chills, swollen and sore tongue, diarrhea, loss of appetite, throat swelling requiring 2 visits to the ER (emergency room). Culminating in Steroid injection and oral Prednisone. Headache, malaise, shortness of breath, thick mucus in nose and throat, hoarseness and sore throat. The adverse events result in Doctor or other healthcare professional office/ clinic visit and Emergency room/department or urgent care. The seriousness of the events was assessed as non-serious by the reporter. Therapeutic measurements were received for the events with steroid injection at the ER and oral Prednisone. The outcome of the events was reported as not recovered. Information on the lot/batch number has been requested.
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| 70 | 2021-02-23 | diarrhea |
3rd day after vaccine: fatigued, headache, unable to concentrate 4th day: disoriented, strange visio...
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3rd day after vaccine: fatigued, headache, unable to concentrate 4th day: disoriented, strange visions when eyes were closed, fatigue, VERY loud ringing in ears, tight chest, puffy eyes, heart racing & pounding 5th day:Diarrhea, fatigue
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| 70 | 2021-02-23 | nausea |
extreme cold internally, head ache and tremors within 10 or 15 mins. Sat for 20 more minutes, then ...
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extreme cold internally, head ache and tremors within 10 or 15 mins. Sat for 20 more minutes, then walked to parking garage. Breathing became labored as I walked the block to car - no one was around. Pulled off mask and sat in car - it subsided in 15 minutes. Body temp was 94.5 remainder of the day. 96.5 today. Awoke nauseated, headache, left foot and hand pain and very sore left arm. Nausea stopped about 3:00 pm, when body tremors started again. Cold all day with no energy
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| 70 | 2021-02-23 | nausea |
A little after midnight, I woke up shaking because I was so very cold. It felt almost like a seizur...
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A little after midnight, I woke up shaking because I was so very cold. It felt almost like a seizure because my lack of control was evident in my movements. With my heaviest PJs on, it took 8 blankets to finally warm me up. I am on a CPAP machine but I was having a hard time getting my breath. I was also nauseous but never threw up. I finally got back asleep a little after 3 am but woke several times after that. This morning, I had a terrible headache and can't get rid of it. Although I feel better than last night, I feel lousy. It is now 2 pm and I just want this to be over. On the first shot, I didn't have any reaction at all.
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| 70 | 2021-02-24 | nausea, burping |
Progress Notes Family Medicine 2/25/2021 ...
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Progress Notes Family Medicine 2/25/2021 Date: 2/25/2021 Subjective Is a 70 y.o. female who was seen at a vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 30 minute waiting period after the injection, the patient began to experience nausea, belching, sob. She denied rash, hives, welts, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , rapid progression of symptoms, respiratory distress and vomiting. PMH: pt reports recently admitted for unstable angina and CAD with tachycardia. Had elevated d-dimer and blood clot was ruled out. Pt dc'd on new medication, beta blocker. Since discharge this Sunday, she reports chest heaviness as if she has "cardboard on my chest." Can slightly increase with going up and down stairs or increased activity. She states she had reached out to her cardiologist via my chart but has not heard back. States her pain is about the same today. Upon 15 minutes after injection, she noted nausea with belching and had some sob. Symptoms worsened as she ambulated over to the medical bay along with her chest pressure. ALLERGY REVIEW OF SYSTEMS: Patient complains of chest tightness and shortness of breath Patient denies chills, malaise/fatigue, sore throat, frequent throat clearing, eyes watering, eyes itching, puffy eyes, eye redness, cough, wheezing, rash, hives, eczema, itching of skin, abdominal pain, muscle aches, dizziness and headaches + nausea and belching: Previous Reactions: none Objective Vitals Vitals: 02/25/21 1000 02/25/21 1008 02/25/21 1013 BP: (!) 157/102 (!) 144/86 (!) 169/94 Pulse: 72 SpO2: 97% Physical Exam Vitals and nursing note reviewed. Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not ill-appearing, toxic-appearing or diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Eyes: General: Right eye: No discharge. Left eye: No discharge. Conjunctiva/sclera: Conjunctivae normal. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Findings: No rash. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: She has nitro on hand. We gave that at 10:03 am. Follow up response to treatment: fair. Patient discharge: Transported to ED by ambulance. Differential Diagnosis: Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Firefighters responded first at 1008 Arrived at 1011. EKG done, no acute findings. Pt reports pain at 0 after nitro administration. Belching and nausea reduced. Pt taken to ED for further evaluation. ED called and given report at 1020 Electronically Signed 2/25/2021 10:24 AM
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| 70 | 2021-02-24 | nausea, vomiting |
After the vaccine my right arm was sore at the injection site. Later that night, after I went to bed...
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After the vaccine my right arm was sore at the injection site. Later that night, after I went to bed around 10:30 pm I started feeling nausea, followed by vomiting twice. Throughout the night I had body aches from head to toe. Also experienced body chills which continued the next morning.
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| 70 | 2021-02-24 | vomiting |
did I have a heart attack. No doctor will see me to give me an EKG; Collapsed; Crushing chest pain; ...
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did I have a heart attack. No doctor will see me to give me an EKG; Collapsed; Crushing chest pain; chest was killing me and hurting and I was sobbing and it lasted about an hour and 15 minutes; Side of my neck hurt; My back hurt; It was just awful; Lethargic; I ended up vomiting for 2 days after the chest pain receded; slept for 16 hours; This is a spontaneous report from a contactable consumer. This consumer reported similar event for 2 patients (husband and wife). This case refers to the wife with serious adverse events. A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982, expiration was not reported), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. Medical history included acid reflux. Concomitant medication included dexlansoprazole (DEXILANT) for acid reflux. Patient reported that she had terrible severe reaction on the 22Jan2021. They were vaccinated on the 18Jan2021 and on the night of the 22Jan2021, she had such crushing chest pain that she just collapsed. Her chest was killing her and hurting and she was sobbing and it lasted about an hour and 15 minutes. The side of her neck hurt and her back hurt. It was just awful. Patient reported that she have called everybody. She have called her doctor's assistant and she confused her. Patient reported that they just went in because they were 70 and 71 and got the vaccine but then she ended up vomiting for 2 days after the chest pain receded and they took baby aspirin and then she just vomited and vomited and slept for 16 hours. They were both very lethargic. She asked her what should she do. She does not know if this was a reaction to the vaccine or did she have a heart attack. No doctor will see her to give me an EKG. They say they are not seeing patients. The patient recovered from chest pain on an unspecified date; while outcome of the remaining events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021115775 same reporter/drug, similar event, different patient.
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| 70 | 2021-02-24 | vomiting |
Five hours after receiving the vaccine my husband I and were both extremely tired and fell asleep fo...
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Five hours after receiving the vaccine my husband I and were both extremely tired and fell asleep for about an hour - we were not able to complete simple tasks and went to bed early. My husband was up every half hour urinating from 6pm until about 3am. We both felt fine this morning but about 11am I got super dizzy and had to sit down, the dizziness caused vomiting and a sever headache. I laid down for about an hour and feel a bit better but the headache has remained!! Hopefully this too will pass in a few more hours! Just thought you might want to know. If it gets worse I will contact my doctor. My husband has not had any other adverse reactions.
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| 70 | 2021-02-25 | diarrhea, decreased appetite, flatulence, GERD, nausea |
Pt received dose #1 Pfizer COVID vaccine 2/4/21 @ vaccine clinic. 2/8/21 @ 1155 presented to ED for ...
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Pt received dose #1 Pfizer COVID vaccine 2/4/21 @ vaccine clinic. 2/8/21 @ 1155 presented to ED for workup of myalgias, nausea, fatigue. Per ED note "chills, onset 4 days ago. Pt recently had the COVID19 vaccine and since, has been experiencing "flu like sx's" and "she feels horrible". She tried imodium, with minimal relief. Endorses abd pain, nausea, diarrhea, GERD, feeling gassy, trying to stay hydrated, decreased appetite. Denies fever, sore throat, congestion, cough, urinary sx's, SOB, CP. Patient is otherwise healthy and has no other complaints." Workup negative, prescribed zofran and discharged home without escalation of care.
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| 70 | 2021-02-25 | difficulty swallowing | Problem swallowing , scratchy throat. Duration <60 minutes. |
| 70 | 2021-02-25 | nausea, vomiting |
I received my first Pfizer Covid injection Feb. 18, 2021. I experienced chills, nausea, some flu s...
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I received my first Pfizer Covid injection Feb. 18, 2021. I experienced chills, nausea, some flu symptoms starting Feb. 22 Monday evening - Feb 25th. I threw up Wed. Feb. 24 morn. I started feeling better on Friday, Feb. 26th and resumed normal activities. My temp from Feb. 22 - 25th was 96.1. I also experienced flu symptoms and felt as if "a truck ran over me".
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| 70 | 2021-02-26 | nausea |
Severe fever chills, fever, sore arm - slightly swollen and red, which then got itchy, extreme sweat...
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Severe fever chills, fever, sore arm - slightly swollen and red, which then got itchy, extreme sweating, tiredness, slight nausea, intermittent headaches, strong muscle and joint pains, slight swollen glands in neck
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| 70 | 2021-02-27 | nausea |
Weakness, vertigo, feeling unsteady, nausea, numbness in extremities, involuntary twitching in calf ...
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Weakness, vertigo, feeling unsteady, nausea, numbness in extremities, involuntary twitching in calf muscle and arms, itchy feeling under the skin, symptoms lasted 4-5 days, improved with Benadryl,
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| 70 | 2021-02-27 | vomiting |
within 1 hour started throwing up, continued for the next 12 hrs. Blood Sugar went to 700 and would ...
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within 1 hour started throwing up, continued for the next 12 hrs. Blood Sugar went to 700 and would not come down with long term and short term insulin. called 911, taken to Hospital ER. on feb. 27 @ 8:00 am Admitted and still is in ICU today 2-28-2021.
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| 70 | 2021-02-28 | difficulty swallowing |
nervousness; slight swelling/tingling in lips; slight swelling/tingling in lips; dizziness; like she...
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nervousness; slight swelling/tingling in lips; slight swelling/tingling in lips; dizziness; like she has a cough in her throat; swelling and soreness of her arm; swelling and soreness of her arm; Tightness in her jaw; Numbness in hand; difficulty swallowing; taste in her mouth; dry mouth; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL3247, unknown expiration), via an unspecified route of administration in left arm on 26Jan2021 at 08:30 AM at a single dose for COVID-19 immunization in a clinic. Medical history included ongoing underactive thyroid, cataract surgery on 14Oct2020 and on 28Oct2020, and cholesterol (abnormal). Concomitant medications included ongoing levothyroxine for underactive thyroid and ongoing rosuvastatin calcium for cholesterol. The patient experienced nervousness, slight swelling/tingling in lips, dizziness, like she has a cough in her throat, swelling and soreness of her arm, tightness in her jaw, numbness in hand on 26Jan2021. The patient also had difficulty swallowing, had taste in her mouth, and dry mouth in Jan2021. The patient on the line calling about the COVID-19 vaccine. She got the shot yesterday (26Jan2021) and was calling to report on the reaction that occurred. She initially stated she had slight swelling/tingling in lips, difficulty swallowing, numbness in hands, jaws became tight, and nervousness which she is still experiencing. She mentioned she took benadryl. She was wondering if she should go and get the second shot. The patient first experienced dizziness which lasted for a second and this occurred while waiting in the lobby for observation after getting the vaccine. Slight swelling and tingling in lips were noticed two minutes after the dizziness. It felt like a tingle sensation. She clarified she does not necessarily have difficulty swallowing. It was not so much she could not swallow, but it was like she has a cough in her throat. It feels like she could cough but would need to keep swallowing and drinking water. Once she got the shot it caused her to get a taste in her mouth. The feeling like a cough in her throat has gone away, but now she feels nervousness, dry mouth, and she still has that taste in her mouth from getting the shot. She had swelling and soreness of her arm, but she knew that was to be expected which started an hour after getting the vaccine. Tightness in her jaw was noticed an hour after getting the vaccine. The numbness in hand started at the same time as the tightness of her jaw. Her left hand is what went numb, and she had the vaccine administered in her left arm. The nervousness is getting better, but she felt very nervous. She also mentioned she has thyroid problems and is not sure if this has anything to do with it. She had this nervousness feeling 2 hours after getting the shot. Patient is scheduled to get the second vaccine on 18Feb2021. Benadryl has helped a lot. The patient has no additional vaccines administered on the same date and has no prior vaccination within four weeks. The events did not require emergency room and physician office visit. Vaccine was not administered in a military facility. The patient was recovering from events nervousness, slight swelling/tingling in lips, swelling and soreness of her arm, tightness in her jaw, and numbness in hand; recovered from dizziness on 26Jan2021; recovered from event "like she has a cough in her throat" on unspecified date; not yet recovered from event "taste in her mouth"; while unknown outcome for the remaining events. No follow-up attempts are possible. No further information is expected.
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| 70 | 2021-02-28 | vomiting, diarrhea, abdominal pain upper |
hour 28 after shot:sweating, chills, flushing hour 48 after shot: severe stomach cramps, diarrhea, v...
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hour 28 after shot:sweating, chills, flushing hour 48 after shot: severe stomach cramps, diarrhea, vomiting, chills--resolved after 9 hours
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| 70 | 2021-03-01 | decreased appetite, nausea | fever 100.9, nausea, no appetite |
| 70 | 2021-03-01 | vomiting |
Headache, vomiting, extreme exhaustion. Vomiting and headache lasted about 2 hours. Slept afterwar...
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Headache, vomiting, extreme exhaustion. Vomiting and headache lasted about 2 hours. Slept afterwards for almost 12 hrs. Thereafter, symptoms gone other than fatigue and sore arm.
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| 70 | 2021-03-02 | decreased appetite |
the day after my first vaccination I woke with bilateral wrist stiffness and pain, bilateral ankle k...
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the day after my first vaccination I woke with bilateral wrist stiffness and pain, bilateral ankle knee and swelling in my ankles. This subsided in a few days. I was holding off on taking my Orencia infusions because I wasn't sure when I would be able to get the vaccine. Orencia dosing is every 4 weeks and I am supposed to take any vaccinations two weeks post infusion. After my second vaccination, I had a full flare. Swollen joints, IBS symptoms, fatigue,fevers, decreased appetite. I went to my rheumatologist and scheduled an infusion as soon as possible. I had to stop taking NSAIDs because my creatinine became abnormal. I had my Orencia 750mg on Februray 1, 2021, but continued to feel ill and started a prednisone
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| 70 | 2021-03-02 | difficulty swallowing, abdominal pain upper, decreased appetite |
fever, chills, itching at injection site followed by severe pain in upper and lower left arm, no uri...
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fever, chills, itching at injection site followed by severe pain in upper and lower left arm, no urine output for 24 hrs, vertigo, fatigue, severe stabbing pains in face and head, stiff neck, no appetite, difficulty swallowing, pain in joints, chest pain, pain across upper back, stomach pain,. Symptoms lasted for 3 to 4 days. Severe head pain lasted 4 days. Could not raise left arm for 24 hrs after injection. After 6 days fatigue and general malaise still present. Stomach pain still comes and goes.
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| 70 | 2021-03-02 | nausea |
For 1 day I had a severe headache , but it resolved . Then I had nausea for 5 days ....still continu...
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For 1 day I had a severe headache , but it resolved . Then I had nausea for 5 days ....still continuing but getting less . Now I have all of sudden tinnitus which I have had only once before when I had a bad reaction to hair dye . The Tinnitus began at 2 PM today , March 3rd ,,,,,and is continuing at this moment . I hope this will resolve . I called all my MD's and they said to call an ENT MD tomorrow if it continues .
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| 70 | 2021-03-02 | retching, nausea |
The data provided included nausea but I don't think that qualifies for my experience. I had dry heav...
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The data provided included nausea but I don't think that qualifies for my experience. I had dry heaves from 2:30AM till 8:00AM. I am right now still somewhat nauseated at 9:13AM same day but at least I'm not retching unable to even keep a sip of water from causing violent retching. I only weigh 118lbs and wonder if the doses are just too strong for that body mass. My doctor told me beforehand to stay hydrated before the shot so I drank lots of water/liquids the days prior to the shot and thought I would be generally OK. I have had no problems with my yearly influenza vaccine or any other vaccine but I would think twice about doing this vaccine again.
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| 70 | 2021-03-03 | diarrhea, abdominal discomfort |
Pain in left arm within 30 minutes of administration. General tiredness/lethargy within10 hours (upo...
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Pain in left arm within 30 minutes of administration. General tiredness/lethargy within10 hours (upon waking next morning). Sore/stiff neck within 14 hours. Body aches, chills within 16 hours. Stomach/abdominal discomfort within 20 hours. Diarrhea at 36 hours. At 36+ hours - arm pain considerably less. Body aches and chills gone by 36 hours. Continued stomach/abdominal discomfort seems to be improving after 40 hours.
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| 70 | 2021-03-03 | nausea |
I received the 1st Pfizer dose on 1/30/21 and 2nd Pfizer dose on 2/20/21. After the 2nd dose, I de...
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I received the 1st Pfizer dose on 1/30/21 and 2nd Pfizer dose on 2/20/21. After the 2nd dose, I developed mild fever (under 100)*F, a bad headache, blurred vision, nausea, joint pain and fatigue. I took Tylenol for the fever and headache and recovered after 2 days. However, on 2/28/21 I developed a SECOND SERIES OF SIDE EFFECTS starting 8 days after the 2nd dose. I developed a fever of 100.7*F , a bad headache, nausea, palpitations, and severe joint pains and strong fatigue. I consulted my PCP, who recommended I fill out this report. I took Advil on 2/28, improved after 2 days, and now have a slight headache and some fatigue but otherwise recovered.
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| 70 | 2021-03-03 | retching |
Patient was admitted due to having a syncopal or near syncopal episode while dry heaving. She was fo...
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Patient was admitted due to having a syncopal or near syncopal episode while dry heaving. She was found to have a probable gastric outlet obstruction and an NG tube was placed initially. She is being followed by general surgery and GI, underwent EGD which showed duodenitis. Pt's diet has progressed to full liquid. She remains in the hospital at this time. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine
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| 70 | 2021-03-04 | diarrhea |
Significant COVID symptoms short of hospitalization including aches severe headaches congestion ling...
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Significant COVID symptoms short of hospitalization including aches severe headaches congestion lingering cough fatigue diarrhea
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| 70 | 2021-03-04 | nausea |
2nd dose at 1615 on March 4, HA started morning of the 5th, pt called and spoke with triage RN at 14...
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2nd dose at 1615 on March 4, HA started morning of the 5th, pt called and spoke with triage RN at 1400, triaged per protocol and pt directed to ED for "worst HA of life". Pt also endorsing fever, nausea, "sparkles" in vision of 1 eye. Pt took tylenol and advil w/o relief (doses unknown).
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| 70 | 2021-03-04 | nausea |
Dizziness, Hot flash starting at the base of my neck & spreading up through my head followed by swea...
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Dizziness, Hot flash starting at the base of my neck & spreading up through my head followed by sweating hands/palms followed by feeling very cold and then cycling back to hot flash, more sweaty palms, & back to chills. Minor nausea. Lasted from 8:15am til 11:30am. I called my care team at clinic they suggested that I call "911", but I did not call "911". My daughter who is a nurse came over to my house & stayed with me until 11:30am. On 03/05/2021 I woke up at 8:00am with a mild headache, minor muscle aches, tired, a little brain fog, & minor nausea which is continuing as of 10:35am as I am completing this form.
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| 70 | 2021-03-05 | nausea | Nausea |
| 70 | 2021-03-06 | diarrhea | Diarrhea and fever for a couple of hours |
| 70 | 2021-03-06 | nausea, abdominal discomfort | fever, body aches, severe headache, nausea, GI UPSET, |
| 70 | 2021-03-06 | nausea |
headache , and nausea for the first two days and fatigue . These were fine . But , the nausea has ...
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headache , and nausea for the first two days and fatigue . These were fine . But , the nausea has continued. It's severe . I went to Hospital emergency room because I was feeling very ill and had developed Tinnitus . The nausea has continued for 10 days . The tinnitus is severe . I have never had Tinnitus , except at brief moments as far as I can remember . I recognized it but have never had it for any length of time . This is ongoing for 3 days now + nausea continues . Scary . I am now on a course of prednisone .
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| 70 | 2021-03-06 | nausea |
Generalized aching , 102 degree fever, nausea and generalized weakness. Symptoms began 10 hours afte...
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Generalized aching , 102 degree fever, nausea and generalized weakness. Symptoms began 10 hours after vaccination and lasted about 30 hours. Treatment was bed rest and naproxen sodium.
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| 70 | 2021-03-07 | abdominal pain, nausea |
began to pass out; because every time I tried to lift my head, I would start blacking out again; diz...
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began to pass out; because every time I tried to lift my head, I would start blacking out again; dizzy; diaphoresis; fell against the wall; violent high abdominal pain; n having multiple, large formed bowel movements; shaking; chills; nausea; fatigue; This is a spontaneous report from a contactable consumer. This 70-year-old female consumer (patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number EM9809) , via an unspecified route of administration on 12Feb2021 at 09:45 (at the age of 70years old) at single dose for covid-19 immunisation. Medical history included hypersensitive to latex, allergies to levaquin, ddavp, CT scan dye, codeine, fentanyl, primary immune deficiency, myasthenia gravis, Sjogren's, autonomic neuropathy, myelodysplastic syndrome, von Willebrand's, Barrett's esophagus on unknown date and unknown if ongoing and received Pfizer Covid vaccine (dose 1, Lot: EL9261) on 22Jan2021 at 2:45am on left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. Relevant concomitant medication was not provided. At approximately 9:50 AM on 12Feb2021, the patient received second Pfizer Covid-19 vaccine in left arm at Administration facility. The patient waited the 15 minutes post injection. At approximately 10:19AM, the patient left site & drove to her home without issues. At home approximately at 11:20am, she had violent high abdominal pain like she never had before. she proceeded to the commode and began having multiple, large formed bowel movements then began to pass out. She began to have diaphoresis and violent shaking and chills. She had passed out on commode and fell against the wall. She later managed to pull pants up and crawl with head hanging down stated that because every time she tried to lift her head, she would start blacking out again. This continued until after approximately 20 minutes. She managed to pull herself up to the couch and raise legs high above heart and head and let head hang off couch to restore blood pressure. The patient mentioned that shot triggered something with her autonomic nervous system. On 22Feb2021, she was still with nausea, fatigue and dizziness. The outcome of events was not recovered. No treatment was received for events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19.
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| 70 | 2021-03-07 | constipation |
The only treatment I sought was self prescribed...Ibuprofen as needed for fever and fluids As the da...
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The only treatment I sought was self prescribed...Ibuprofen as needed for fever and fluids As the days progressed, I feel tightness and heaviness in my chest.. Almost as if there is an upper respiratory infection Thursday evening, I started running a fever and had a sore throat that would not quit Fever was in range of 101 degrees As the day progressed on Friday, the fever returned and spiked to 101 in the evening Saturday more fever in the evening to 102 degrees. Sore throat sort of subsided Constipation set in and has still not resolved itself Today, Monday; I was hoping for relief but none Looking at this report...I am frightened of consequences I am generally in good health
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| 70 | 2021-03-07 | decreased appetite, nausea |
Fever, chills, headache, nausea, body aches, redness and sore left arm, lack of appetite, couldn't s...
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Fever, chills, headache, nausea, body aches, redness and sore left arm, lack of appetite, couldn't sleep, fatigue, rash at injection site and down the arm and then several days post injection rash on thigh
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| 70 | 2021-03-07 | nausea | Extreme Fatigue Headaches Mild Nausea |
| 70 | 2021-03-07 | nausea |
Since March 1, every day I have felt dizziness and some nausea throughout the day, when I get up out...
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Since March 1, every day I have felt dizziness and some nausea throughout the day, when I get up out of bed in the morning, bend down and come up when doing laundry, cleaning, kitchen work, dressing, exercise and other normal daily activities. I must keep my upper body and head upright, and avoid bending, in order to prevent this dizziness. As a result, I feel weak and uncomfortable, and fear doing normal movement and activity.
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| 70 | 2021-03-07 | vomiting, loss of appetite, nausea |
Patient received first Pfizer COVID-19 vaccine on 1/20/2021 and second dose on 2/12/2021. Patient ha...
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Patient received first Pfizer COVID-19 vaccine on 1/20/2021 and second dose on 2/12/2021. Patient had minor symptoms such as body aches with both vaccine doses which resolved. Patient then stated she started to experience headache, nausea, and body aches, decreased oral intake, and chill starting on 2/18/2021. On 2/20/2021 patient had several loss of consciousness episodes. Patient presented to the Emergency Department on 2/21/2021 with a chief complaint of syncope, nausea, and vomiting and subsequently admitted to the hospital for potential sepsis, syncope, hyponatremia, dehydration, lactic acidosis. (Continued on second page)
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| 70 | 2021-03-08 | abdominal pain |
Exactly 8 hours after the vaccine was given, I felt very fatigued, felt cold, had a mild headache, a...
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Exactly 8 hours after the vaccine was given, I felt very fatigued, felt cold, had a mild headache, and had sharp, but not debilitating, pain in both the right and left side of my lower abdomen whenever I moved. The symptoms lasted 24 hours except for the mild headache which is still continuing one week after the vaccine was given.
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| 70 | 2021-03-08 | difficulty swallowing |
AT 9:30 PATIENT WAS UNABLE TO SWALLOW, MUSCLES IN NECK, THROAT AND JAW WERE VERY TIGHT; COULDNT SWAL...
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AT 9:30 PATIENT WAS UNABLE TO SWALLOW, MUSCLES IN NECK, THROAT AND JAW WERE VERY TIGHT; COULDNT SWALLOW OR SPIT. TIGHTNESS MOVED DOWN TO SHOULDERS AND CHEST. PT WENT TO ER ; STARTED SHAKING UNCONTROLLABLY, THIS STARTED AND STOPPED 3 TIMES; ALSO HAD HEADACHE, FEVER AND CHILLS, ER GAVE HER IV BENADRYL AND PT IS STILL TAKING BENADRYL.
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| 70 | 2021-03-08 | nausea |
Client c/o nausea, weakness and dizziness during observation client appears flush and pale. Client s...
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Client c/o nausea, weakness and dizziness during observation client appears flush and pale. Client seen and assessed by EMT. A series of vitals: BP 90/20, HR 43, (2nd), BP 118/90, HR 64, O2 92. (3rd)108/84, HR 60, O2 90, Client advised to go to ER by paramedic. Client's daughter voiced that she will take her mom to ER herself. After 3rd vital assessment was taken client states that she will call her primary Dr. and inform her about the reaction and will follow up with what ever MD advises. Client cleared to go home by EMT.
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| 70 | 2021-03-08 | stomatitis |
The roof of my mouth was covered in canker sores for over a week. This usually happens if I am gett...
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The roof of my mouth was covered in canker sores for over a week. This usually happens if I am getting the flu or some kind of virus. I have never had it to this extent before.
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| 70 | 2021-03-09 | decreased appetite |
She received the vaccine, and went to bed at midnight and felt great all day long. She believes abo...
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She received the vaccine, and went to bed at midnight and felt great all day long. She believes about 5 minutes later started having chills. She has a weighted blanket and had that with 2 other blankets on her, and started shaking, and then her teeth started chattering and could not prevent them from banging together. She was afraid she was going to break a tooth. This lasted for almost an hour. She finally fell asleep and normally does not move when sleeping, and tossed and turned all night. She usually gets up a couple of times a night to use the bathroom, and did not get up until 6:00 Am, and when she tried to get up she was woozy, and was not able to walk due to feeling like she was going to fall over and almost fell in the bathroom but has grab bars that she was able to grab. She normally gets up at 4:00 Am, and got up at 8 after getting up at 6. She was not able to sit up and when she got up for the day was listing like a drunken sailor and not able to eat and managed to get some water down. She did take a Tylenol, and took her VS which were normal. She had tried to call her doctor but due to weakness was not able to. She was still uneasy from a deep sleep last night, but today she is feeling better but afraid of losing her balance. Her arm is still a little sore, but pretty good right now.
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| 70 | 2021-03-09 | diarrhea, abdominal distension, abdominal pain |
Two hours after injection, I began wheezing. Four hours after injection, the wheezing worsened, the ...
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Two hours after injection, I began wheezing. Four hours after injection, the wheezing worsened, the inside of my mouth started itching, and I had abdominal pain, bloating, and diarrhea. These symptoms lessened the next day but continued for one week. I did not report these reactions immediately, as I did not want them to prevent my receiving the second covid vaccine dose. Also, if the second covid vaccine dose started to cause the same type of reaction, I was prepared to use two Epi Pens and call 9-1-1. Fortunately, the second dose caused only a sore arm.
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| 70 | 2021-03-09 | diarrhea |
Patient received vaccine in the morning 3/6/2021. In the evening, patient developed multiple episod...
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Patient received vaccine in the morning 3/6/2021. In the evening, patient developed multiple episodes of profuse diarrhea. She did become lightheaded, fell, and 'broke my tailbone.' She did see a family medicine physician 3/8/2021 - patient did pass out per the note but did not hit her head. +camps -nausea -emesis No known contacts to anyone with illness or diarrhea
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| 70 | 2021-03-09 | diarrhea | Tiredness, mind fog, diarrhea |
| 70 | 2021-03-09 | nausea |
injection site pain, tiredness, headache, joint pain in knees, chills, nausea , feeling unwell week ...
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injection site pain, tiredness, headache, joint pain in knees, chills, nausea , feeling unwell week and dizzy
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| 70 | 2021-03-09 | nausea | Fever, headache, body aches, slight nausea |
| 70 | 2021-03-09 | nausea | exhausted, nauseated, achy, chilled |
| 70 | 2021-03-10 | diarrhea, nausea |
Inflammation in areas with arthritis, chills, fever, coughing and congestion in lungs, fatigue, dep...
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Inflammation in areas with arthritis, chills, fever, coughing and congestion in lungs, fatigue, depression, lethargy, brain fog, nausea, diarrhea, pinched nerve between should blades, swelling in both hips
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| 70 | 2021-03-10 | diarrhea |
Hoarseness, joint and muscle aches, chills, dizziness, diarrhea. Symptoms present upon waking next d...
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Hoarseness, joint and muscle aches, chills, dizziness, diarrhea. Symptoms present upon waking next day after vaccine and have continued for 36 hours. They are unresolved at this time.
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| 70 | 2021-03-10 | difficulty swallowing |
Muscle pain; Headache; Having issues breathing; could not swallow; Muscle tightness in right jaw, mo...
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Muscle pain; Headache; Having issues breathing; could not swallow; Muscle tightness in right jaw, mouth, neck, shoulder; Muscle type convulsions in neck, shoulder, arms and upper chest; This is a spontaneous report from a contactable consumer reported for self. This 70-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via intramuscular on 24Feb2021 at 10:00 AM at single dose in left arm in a pharmacy or drug store for COVID-19 immunization. The patient's medical history included high blood pressure. The patient had known allergies: anabolic steroids, many antibiotics. The patient did not have COVID prior vaccination. The patient's concomitant medications included hydrochlorothiazide, triamterene (MAXZIDE) and vitamins. At 24Feb2021 at 10:00 PM, the patient experienced muscles in neck, jaws and throat started clinching up and she could not swallow. The patient began having issues breathing. The patient was advised to go to emergency room (ER). At ER, patient started with muscle type convulsions in neck, shoulder, arms and upper chest. The patient had several episodes. Doctor administered diphenhydramine hydrochloride (BENADRYL) intravenously, did blood and urine workup. After 4 hours the shaking stopped, and the muscle contractions lessened. The patient was sent home. Next day 25Feb2021, she still had some residual muscle tightness in right jaw, mouth, neck, shoulder. On third day 26Feb2021, she had light shaking of hands and arms. The patient was still taking 25 mg diphenhydramine hydrochloride every 8 hours. She added ibuprofen (ADVIL) because she also had muscle pain and headache. The patient was recovering from the events. The patient did not test COVID post vaccination. Information on lot/batch number has been requested.
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| 70 | 2021-03-10 | burping, nausea |
SV for unstable angina; CAD; Tachycardia; Nausea; Belching; SOB; Chest heaviness, chest pressure, ch...
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SV for unstable angina; CAD; Tachycardia; Nausea; Belching; SOB; Chest heaviness, chest pressure, chest tightness; Pain; This is a spontaneous report from a non-contactable other HCP. A 70-year-old female patient received the first dose of bnt162b2 (lot number EN6205) via unspecified route of administration on unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not provided. Upon 15 minutes after injection, she noted nausea with belching and had some SOB. Symptoms worsened as she ambulated over to the medical bay along with her chest pressure. She denied rash, hives, welts, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. Patient reported recently admitted for unstable angina and CAD with tachycardia. Patient had elevated d-dimer and blood clot was ruled out. Patient discontinued on new medication, beta blocker. Since discharge this Sunday 21Feb2021, she reported chest heaviness as if she has "cardboard on chest." Can slightly increase with going up and down stairs or increased activity. She states she had reached out to her cardiologist via an online site but has not heard back. Patient stated her pain is about the same today. Patient complains of chest tightness and shortness of breath. The outcome of events was unknown. No Follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association, the contribution of the suspect drug to the onset of events unstable angina and tachycardia cannot be excluded. The patient's age and suspected cardiac condition are risk factors. The event CAD, given its progressive nature, is most likely an underlying condition, thus unrelated to the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 70 | 2021-03-10 | nausea, decreased appetite |
Fluctuating temp, 100.3-97.5 for 5 days, muscle weakness, body aches, unsteady on my feet, nausea, n...
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Fluctuating temp, 100.3-97.5 for 5 days, muscle weakness, body aches, unsteady on my feet, nausea, no appetite, brain fog, extreme fatigue, for 8 days or more. COPD so much worse that I had to use albuterol twice a day which I didn't use before lasting 2 weeks. No daily walk for 2 weeks because I couldn't balance properly. Sweats and chills not corresponding to temp fluctuation 2 weeks. Night sweats which I have never had before EVER. My scleritis kicked in really bad, worse than ever before. I still don't feel well 19 days later
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| 70 | 2021-03-10 | nausea |
Two days after the vaccine I began having chills and nausea, after that day I?ve felt queezy all the...
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Two days after the vaccine I began having chills and nausea, after that day I?ve felt queezy all the time,, however waves of extreme nausea pass over me with chills. I have been hoping each wave is the end. Reading ?side effects? it should be gone in 3 days. However today, 10 days later, was worse than ever . I spent the whole day in bed nauseated and vomiting, chilled with 4 blankets over me. My temperature was not high (97). I keep hoping the side effects are finished, but this has gone on longer than your information predicts. This is too long to feel this way.
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| 70 | 2021-03-11 | nausea |
Flu-like like symptoms. Headache, chills, low grade fever, extreme fatigue, some queasiness. Symptom...
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Flu-like like symptoms. Headache, chills, low grade fever, extreme fatigue, some queasiness. Symptoms have persisted for 10 days at this point and are no better. Chills seem to be getting worse. Advil helps Headache and chills, but I can't take it every day without upsetting my stomach.
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| 70 | 2021-03-11 | nausea |
Pancreatitis, mild. In addition had fever/chills, nausea, headache, joint pain all in first 24 hour...
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Pancreatitis, mild. In addition had fever/chills, nausea, headache, joint pain all in first 24 hours.
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| 70 | 2021-03-11 | vomiting |
Injection site pain Headache with ?brain zaps? for a period of 2+ hours Joint pain over entire body ...
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Injection site pain Headache with ?brain zaps? for a period of 2+ hours Joint pain over entire body Chills with severe trembling Fever Vomiting for a period of hours Severe itching on my back, shoulders and upper arms for two days
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| 70 | 2021-03-13 | nausea, indigestion | Headache, nausea, heartburn, chills, pain in arm pit on same side as shot was given and tiredness. |
| 70 | 2021-03-14 | abdominal discomfort |
syncope; afib; afib; soreness, redness, and pain at injection site/left arm pain/under arm pain; sor...
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syncope; afib; afib; soreness, redness, and pain at injection site/left arm pain/under arm pain; soreness, redness, and pain at injection site; her blood pressure was really high and kept going up and down like a roller coaster; She was taken to the ER and began feeling sick to stomach in ambulance; headache; felt her ears vibrating; Breast, arm and clavicle starting hurting two weeks and one day after the injection; Breast, arm and clavicle starting hurting two weeks and one day after the injection; Breast, arm and clavicle starting hurting two weeks and one day after the injection; She is anxious about getting the second vaccine; Enlargement of lymph nodes; increased heart rate; This is a spontaneous report from a contactable Nurse reported for self. This 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Feb2021 on Arm left at single dose (Lot # EL9262, Expiration: May2021) for covid-19 immunisation. Medical history included Atrial fibrillation from Jan2020. Had 2nd dose appointment scheduled but canceled appointment. Concomitant medications included apixaban (ELIQUIS) from 07Feb2021 at 5mg twice a day by mouth (provided SN100089537925, LOT 1771228, EXP: May2023, NDC: 0003-0894-21) for Atrial fibrillation. History vaccine included a Tetanus shot 40 years ago (1981) for immunisation and reacted terrible to it. She reports having and experienced soreness, redness, and pain at injection site. She reports getting a mammogram sometime after receiving the vaccine. They saw a spot they are going to recheck and saw swollen lymph nodes on the left side/ Enlargement of lymph nodes, which is the same side she received her vaccine. She was told it was most likely due to the vaccine. Six days later she suddenly felt sick, near syncope, couldn't catch her breath. It got so bad she thought she was dying and called EMS. Leads confirmed afib, her blood pressure was really high and kept going up and down like a roller coaster. She was taken to the ER and began feeling sick to stomach in ambulance. IN the ER she received 1000 ml of fluids and additional metoprolol in addition to dose she took that evening at home. She was sent home to follow up with her Cardiologist the following Monday. He wasn't sure if it was due to vaccine and started her on twice daily eliquis and increased her toprolol immediate release to twice daily. The following Friday night she got a headache and felt her ears vibrating. Her home EKG was fine, but blood pressure was high again and stayed up for hours. Took additional toprolol. Came down after 5 hours. Breast, arm and clavicle starting hurting two weeks and one day after the injection. She is anxious about getting the second vaccine. Asked PCP if she needed an antigen test to see if she needed a second dose of the vaccine. She says she got her first dose 01Feb, then on Wednesday, 03Feb she went and got a mammogram which had already been planned. She says that they saw enlarged lymph nodes to her left breast, under arm, and clavicle which they said are due to vaccine, but they also said they saw something else so they wanted to do a repeat mammogram three months later. She says it took two weeks, but suddenly her left breast and under arm were killing her, caller did not clarify this statement. She says she talked to her doctor who said don't worry it might take a while to go down. She says that the other thing is she has known atrial fibrillation that was diagnosed a year ago, and most of the time it is quick and doesn't last long, sometimes she doesn't know she is having it. She says 6 days after the first dose she started to feel ill, she had been in bed reading so she got up to get some water and suddenly felt like something was wrong and like she was going to pass out, she couldn't breathe, so she called EMS. She says her atrial fibrillation is not unusual, but she has never had it to where she couldn't breath. She says that the rate they estimated was 350, and her only other documented that was high like that was 150. She says that they treated her and she went home, and when she saw her cardiologist they said they don't know if the vaccine had to do with this, and to report it. She says a week later, on Friday a week ago, she started feeling funny standing while she was working on the computer in the middle of the afternoon, she felt like her ears were vibrating, which was very unusual, and she didn't know what was wrong so she looked at her Cardia app, and her heart was in normal sinus, and she checked her blood pressure which for her was sky high, up to 190/100 which her blood pressure is usually very low. She provided a second blood pressure that call handler was unable to capture and caller did not clarify as she no longer had her log with her. She says for hours her blood pressure (BP) went up and down, which was a similar or same thing as what happened that night she went to the ER with her atrial fibrillation, her BP would go up and down like riding a wave. She says needless to say, she has two questions: she says she doesn't know if there have been reports of that vaccine making A-fib worse, she is scared to get her second dose which she was supposed to get Monday a week ago, but put off primarily before the second thing with BP, she thought she would wait because she could hardly move her left arm so she put it off until the next Wednesday, She says that her second dose is now scheduled for 03Mar, so 4 weeks between doses, and she is a little afraid to get it because she doesn't know if her response was over the top or caused the other things, going to the ER with A-fib was terrifying, and she doesn't want that to happen again. She says people say that she has got to get her second dose because she won't be protected, so she would also like to know if it is possible for her to get antigens early on. She says that she had a tetanus shot 40 years ago, and had a horrible reaction after it, then years later they did a titer for tetanus and they said she would likely never need a tetanus shot again since she had built up such a high level and would never need it again. She says is it possible that she had enough immunity that she wouldn't need the second dose, or would there be an antigen test that could tell her if she would need a second dose, if so what is that test? She says she is afraid the next dose will kill her. AE treatment included says that when she went to the ER it was about 12:30AM when she arrived, they did not admit her. She says on the way to the ER in the EMS truck they gave her Cardiozyme to get her blood pressure going down and gave her 1000 cc fluids, and Metoprolol, another dose. She says that the Cardiozyme was IV push in the ambulance, she doesn't have the information to provide for all of the heart stuff they gave her, NDC/LOT/EXP: Unknown for Metoprolol or Cardiozyme. She clarifies that she takes Metoprolol normally every day that they have had her on that is extended release and she takes it at night. She says she had taken that at 09:30PM, and by the time she got there to the ER after midnight a little, they after gave her another to see if it would bring her heart rate down. She says that they kept her there a couple of hours, until her heart rate was normal, though her BP was up a bit. She says that they told her they could admit her but she said she would rather go home if they thought it was safe, and she went home. She says that her sister came home and stayed with her, whose husband is a cardiothoracic surgeon. Metoprolol: Caller says that the Metoprolol she is taking is in a pharmacy bottle that says use by 08Feb2022, it does not have an official label, the NDC or LOT are not on there. She says that they gave her 60 to take of regular Metoprolol, not extended release, which is 25mg to take twice a day by mouth, so 60 tabs and she would need to get refills as it is a months worth. Metoprolol extended release NDC/LOT/EXP not provided when queried. She clarifies that the not extended release is called Toprol/Metoprolol Tartrate 25mg. Caller says that her swelling lymph node limited the use of her arm, she can't pick up anything or lift her self up while moving in the bed, she is miserable, it hurts to put pressure on her arm and she can hold her arm up and move it around she can do anything with not holding anything, she feels a tightness there, even when she breathes or coughs. She says her left arm was sore initially for 3-4 days after getting the shot but the soreness left. She says she was told on 03Feb that she had swollen lymph nodes, which was two days after the shot, but she couldn't feel them then, she couldn't tell, and had no pain. She says it was two weeks later that happened, it was so odd that it was two weeks before it was hurting then got progressively worse. Caller says that Tuesday a week ago she thought she must have done weights with her arms since her muscles were sore, but it was only on one side and she hadn't done any exercise since after she went to the ER she was being careful what she did, and she thought she strained her arm and realized what it was, it has gotten progressively worse over the last week. She says last night she started looking up remedies, she has been putting ice on it, and the clinic said use warm, and she rubbed castor oil on it last night in the shower then this morning she massaged her arm with castor oil and put a warm wash cloth over it. She says that castor oil has anti inflammatory properties. She says she has not noticed a difference yet, but she has only done it two times. She says it also said she can take Aleve or Ibuprofen, they told her at the ER, they also started her on Eliquis the night she was there, which she had never been on, they didn't consider her A-f fib bad enough. She says that is what has her concerned, she got the shot then 6 days later A-fib made her feel like she couldn't breathe. She says also her BP and heart rate going back up made her sick to her stomach that subsided when her BP was coming down but then it started going back up again, when she went to the ER that Saturday night on the 6th but by the time she got there it was the 7th. Outcome of the events was unknown.; Sender's Comments: The possibility that suspect drug may have contributed to the reported event cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 70 | 2021-03-14 | decreased appetite |
Pain and swelling at injection site - unable to raise arm above head Treated with Tylenol. Resolve...
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Pain and swelling at injection site - unable to raise arm above head Treated with Tylenol. Resolved in 36 hours. Severe generalized headache, myalgia, arthralgia, extreme fatigue, loss of appetite, but no fever. No analgesic helped symptoms. Required bedrest for three full days. Symptoms resolved after four days.
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| 70 | 2021-03-15 | diarrhea, nausea, vomiting |
few heart quivers/heart is trembling/occasionally feeling her heart jumping around a bit/occasionall...
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few heart quivers/heart is trembling/occasionally feeling her heart jumping around a bit/occasionally her heart is still quivering for no rhyme or reason; Vomiting; exhausted all day from being sick; exhausted all day from being sick; feeling slightly queasy/queasiness; diarrhea actually started before 1 AM/but was mild and escalated and by 1 AM it was extremely bad; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EL9264; Expiration Date: May2021), intramuscular, administered in Arm Left (left upper arm) on 25Feb2021 11:00 (at 70-year-old) at 0.3 mL, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. Vaccination Facility Type was clinic. The patient previously took flu shot (she took the flu shot every fall and she has never had a reaction like this). It was reported that the patient started feeling queasy within 1 hour of the dose the same day. She confirmed by 1 AM 26Feb2021 she had diarrhea and vomiting which was about 14 hours after shot. She says the diarrhea actually started before 1 AM, so could have been 25Feb2021, but was mild and escalated and by 1 AM it was extremely bad. She confirmed the diarrhea was mild the same day as the vaccine and then got worse. She has also had a few heart quivers since this happened nothing constant but occasionally she feels like her heart is trembling. She thinks it was Saturday which would have 27Feb2021 because Friday, the day after the vaccine she was exhausted all day from being sick and maybe from the vaccine also but she thinks it was the next day, Saturday when she started occasionally feeling her heart jumping around a bit. She says occasionally her heart is still quivering for no rhyme or reason, just every once in a while she notices it. She says hopefully if she does take the second shot she will do better. The outcome of the event " few heart quivers/heart is trembling/occasionally feeling her heart jumping around a bit/occasionally her heart is still quivering for no rhyme or reason" was not recovered, "exhausted all day from being sick" was unknown, while for other events was recovered.
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| 70 | 2021-03-15 | diarrhea, vomiting |
2nd injection was was March 13, 9:30 am. Slept that night (Saturday) for 10 hours. Sunday stayed a...
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2nd injection was was March 13, 9:30 am. Slept that night (Saturday) for 10 hours. Sunday stayed at home. Monday (3-15-21) did a few errands and had constant diarrhia By 7:00 pm did not feel well and went to bed. Had nothing to eat all day, and by 8:00pm was vomiting fluids only and more diarrhia. slept fitfully with muscle cramps, shivers, then seats-cold and hot throughout the night. Finally awake and out of bed my 11:00 am
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| 70 | 2021-03-15 | nausea, abdominal discomfort |
Headache, 102 Fever, nausea, chills, body aches, extreme fatigue Started 3-13-2021 at 7 pm until 03/...
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Headache, 102 Fever, nausea, chills, body aches, extreme fatigue Started 3-13-2021 at 7 pm until 03/14/2021 @ noon Nausea/upset stomach and extreme fatigue until 3/15/2021 Continue to have mild upset stomach and body fatigue with irritated airway
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| 70 | 2021-03-15 | nausea, diarrhea |
I experienced sudden uncontrollable diarrhea (not watery) at end of waiting period 15 minutes. It c...
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I experienced sudden uncontrollable diarrhea (not watery) at end of waiting period 15 minutes. It continue for short trip (5 minutes) home and using bathroom for 1/2 hour. Once home I also experienced nausea. Nausea rest of the day. Only drank ginger ale. Better by evening.
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| 70 | 2021-03-15 | nausea, vomiting |
4:45pm nausea, acute fatigue, headache 5:55pm vomiting x2, low fever, chills x 3.5 hours 9:25pm fat...
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4:45pm nausea, acute fatigue, headache 5:55pm vomiting x2, low fever, chills x 3.5 hours 9:25pm fatigue and flu-like aches only, acute symptoms lessening
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| 70 | 2021-03-15 | nausea |
she was freezing cold but no temperature registered; nausea; no energy; she was sleepy; head hurt; c...
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she was freezing cold but no temperature registered; nausea; no energy; she was sleepy; head hurt; chills but no temperature; fever; fatigue/exhausted; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EN9810, expiry: unknown), intramuscular in the muscle of her right shoulder on 05Feb2021 11:00 at a single dose for covid-19 immunization at a public health department. The patient has no medical history and concomitant medications. The patient is experiencing chills but no temperature on Feb2021, fever on Feb2021, fatigue on Feb2021, nausea, and no energy. She had her first shot last Friday (05Feb2021) and was fine. She stated that yesterday afternoon (11Feb2021), she felt really bad. She called the clinic to see if it was symptoms of Covid. She stated that she was freezing cold, but no temperature registered on 12Feb2021 at 13:00. Her head hurt on 11Feb2021 13:00 and she took Ibuprofen but it never let up, so she took Tylenol. She was sleepy on 11Feb2021 14:00 and was napping so she laid on the couch. The patient was also nauseous on 11Feb2021 14:00 but never threw up. She called the clinic to see if she should get tested for Covid. She stated that since she got up that she is exhausted, felt like she had no energy on 11Feb2021 14:00. The patient wanted to know if she needed to be concerned or if this is something that will run its course. She had to go get blood work at the hospital on Wednesday and that everyone had on masks and she did not think that she was exposed. The patient has no prior vaccinations (within 4 weeks). The outcome of the events feeling cold and feeling of total lack of energy was recovering, head pain and nausea recovered on 11Feb2021 while event sleepy was not recovered. The outcome of the other events was unknown.
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| 70 | 2021-03-15 | nausea |
Took 1 hour to drive to pharmacy. Noticeable effects started on way home. Started to feel nauseous, ...
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Took 1 hour to drive to pharmacy. Noticeable effects started on way home. Started to feel nauseous, and from my neck to entire head, I felt swollen. Got home, collapsed in chair, had a faint sign of difficulty breathing, but not bad. Still felt swollen. Disappeared about 2 hours at home. Nausea getting worse. Feeling chilled, feverish, and dizzy. Unable to sleep that night, so nauseated I couldn?t even swallow water without wanting to puke. Shot on Tuesday, didn?t feel much better till Friday. Ok now.
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| 70 | 2021-03-15 | stomatitis |
received vaccine on 3-11 and 2 hours later total body aches. on 3-13 she woke up with blisters and r...
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received vaccine on 3-11 and 2 hours later total body aches. on 3-13 she woke up with blisters and rash to both lips and sores in mouth, rash to right anterior chest and chills
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| 70 | 2021-03-16 | abdominal pain upper, nausea |
Headache, stomach ache dizzy nausea pain in shoulder very sore , blood sugar dropped to 60, blood...
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Headache, stomach ache dizzy nausea pain in shoulder very sore , blood sugar dropped to 60, blood pressure 185 systolic; has not been to doctor yet
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| 70 | 2021-03-16 | nausea, vomiting |
I thought I was going to die; Sick; over a 103 temperature/the fever was so high; I had such bad chi...
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I thought I was going to die; Sick; over a 103 temperature/the fever was so high; I had such bad chills; nausea; I would throw it up; arm was so bad, it had it's own pulse, a pulse of it's own, I couldn't lift it at all plus the pain was like a tooth ache pain; checks your oxygen level and normally its 98-99, it went down to 91/her oxygen level was down to 90; my chest was shortness of breath; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored program. A 70-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on 24Feb2021 (at the age of 70-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included viruses, flus (I have had viruses, flus my whole life), five surgeries, gallbladder removed, and asthma, all from unspecified dates and unspecified if ongoing. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) on an unspecified date, at the age of 70-years-old and experienced a very sore arm. On an unspecified date in Feb2021 the patient experienced, "I thought I was going to die", "sick", "over a 103 temperature/the fever was so high", "I had such bad chills", "nausea", "I would throw it up", "arm was so bad, it had its own pulse, a pulse of its own, I could not lift it at all plus the pain was like a tooth ache pain", "checks your oxygen level and normally its 98-99, it went down to 91/her oxygen level was down to 90" and "my chest was shortness of breath". The clinical course was reported as follows: "I wanted to call today because I got the Pfizer COVID Vaccine 3 weeks ago, 03Feb2021 it was. After the first dose I had a very sore arm and that was it. It was more sore than normal vaccine, but it was that was all I had. After the second dose I was not aware that I would get sick to the extreme that I did. I found out afterwards that other people have said this, I did not know at the time. I thought I was going to die. I am a 70-year-old woman, I am not young, and I have had viruses, flus my whole life and I got so sick. First, I had over a 103 temperature, it came on suddenly, 12 hours to the minute after I got the vaccine. On top of that I had such bad chills I never saw anything like that in my life, 5 blankets on top of me, sweaters, sweatshirts and the fever was so high. I could not keep the Tylenol down because I had nausea and I would throw it up. So, I could not even get rid of it. Then on top of that my arm was so bad, it had its own pulse, a pulse of its own, I could not lift it at all, plus the pain was like a tooth ache pain, it was excruciating. I have had 5 surgeries, my arm hurt worse than all 5 surgeries put together. And I had my gall bladder removed and everything, nothing hurt to this extent. Now also I have asthma, nothing severe but I do have asthma, so I have one of those little oximeters and you put it on your finger and it checks your oxygen level and normally its 98-99, it went down to 91, all night it was 91, my chest was shortness of breath. I was ready to go to the hospital. And I did not know it was going to be that bad." When clarified about the treatment the patient stated that "yes, the Tylenol helped once I could hold it down. The doctor gave me something to stop the vomiting and the nausea. And then I could take the Tylenol and then the Tylenol worked great. But at first, I was so sick I could not hold the Tylenol down in my stomach I would throw it up, that was the problem." When asked about lab work the patient stated that she had not had lab work done since the first vaccine. She stated that she had stayed in the house because she had other health issues and was afraid to come out for 11 months. So she had not gone out to get anything done. The patient stated that she called because if a third dose was needed, she suggested that a smaller dose be given to small people. She stated that she took childrens medicine most of the time because she was tiny. She wanted to know if Pfizer in the future would be making doses for small people and doses for bigger people. Her suggestion was to have a separate booster to go by weight or by gender, men usually did not experience the same. The clinical outcomes of the events "I thought I was going to die", "sick", "over a 103 temperature/the fever was so high", "I had such bad chills", "nausea", "I would throw it up", "arm was so bad, it had its own pulse, a pulse of its own, I could not lift it at all plus the pain was like a tooth ache pain", "checks your oxygen level and normally its 98-99, it went down to 91/her oxygen level was down to 90" and "my chest was shortness of breath" were all recovered/resolved on unspecified dates. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 70 | 2021-03-16 | nausea |
Symptoms: Headache, nausea, body and joint ache, fever. Treatment: Tylenol and bed rest Time c...
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Symptoms: Headache, nausea, body and joint ache, fever. Treatment: Tylenol and bed rest Time course: 18 hours and continuing.
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| 70 | 2021-03-16 | nausea |
Very high fever (I think), sweating (lost 4 lbs of 123), nausea, passed out. Husband found me on t...
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Very high fever (I think), sweating (lost 4 lbs of 123), nausea, passed out. Husband found me on the ground (just a short time), shook me, and I responded. Went to bed, stayed in bed the next day.
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| 70 | 2021-03-17 | nausea | chills, fatigue, body aches, nausea, headache |
| 70 | 2021-03-18 | diarrhea, vomiting | Back ache, chills, vomiting and diarreau |
| 70 | 2021-03-18 | nausea | Short of breath headache chest pain nausea cold symptoms |
| 70 | 2021-03-18 | nausea |
I had minor side effects on January 28, 2021 first dose. My second dose was February 15, 2021. I cal...
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I had minor side effects on January 28, 2021 first dose. My second dose was February 15, 2021. I called an ambulance at about 2:00 am on February 18, 2021, with severe pain on the left side of my face and left neck. The pain in my teeth felt like it was being drilled. I was nauseated and the ambulance people thought I was having a heart attack. My blood pressure is normally 110/65, but it was close to 200/104, I think they said. A few days later I went to another ER because the doctor thought I was having a stroke.
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| 70 | 2021-03-18 | vomiting, nausea |
I received the vaccine ar 1:30 Pm and i felt Nausea in 1 hour that persisted for several hours , res...
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I received the vaccine ar 1:30 Pm and i felt Nausea in 1 hour that persisted for several hours , resulting in vomiting at 9 PM I was nauseated the enitre next day without vomiting
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| 70 | 2021-03-19 | difficulty swallowing |
This was 2nd dose. Starting before I sat down in the observation area: Pressure and pain at back of ...
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This was 2nd dose. Starting before I sat down in the observation area: Pressure and pain at back of neck, dizziness, difficulty swallowing. This persisted until 3/17. I had a similar reaction to the first dose. 3/15: Rash on face and neck. 3/16 Rash spread to chest and upper arms. 3/17 face swollen; headache, scratchy throat. 3/18: Symptoms subside by end of day, although skin still a little blotchy. I did tell the person who gave me the injection about my reaction to the first dose and she looked for the rapid response team to watch me, but she didn't find them. I suggest a sign in the waiting area indicating which symptoms are of concern (hard to distinguish immune response from allergy and/or anxiety attack.
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| 70 | 2021-03-19 | nausea, decreased appetite, diarrhea |
Nausea,weakness, lack of appetite,wheezing,coughing ,sneezing, diarrhea. I can not stay out of bed ....
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Nausea,weakness, lack of appetite,wheezing,coughing ,sneezing, diarrhea. I can not stay out of bed . Please help me . I have taken Tylenol
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| 70 | 2021-03-20 | nausea |
lethargy; Chills; fever; muscle soreness; Major headache; nausea; Bad reaction at injection site; Th...
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lethargy; Chills; fever; muscle soreness; Major headache; nausea; Bad reaction at injection site; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM9810), via an unspecified route of administration, administered on the Left arm on 04Feb2021 14:30 as SINGLE DOSE for covid-19 immunisation. The patient medical history was none. If other vaccine in four weeks: No. Other medications in two weeks: no. Other vaccine same date details: other vaccine same date dose number was 2. Facility type vaccine was Hospital. If covid prior vaccination: No. If covid tested post vaccination: No. Known allergies: No. The patient experienced lethargy, chills, fever (pyrexia), muscle soreness (myalgia), major headache (headache), nausea and bad reaction at injection site (injection site reaction); all (non-serious) on 04Feb2021 17:30. Adverse event: Chills, fever, muscle soreness, major headache, nausea, lethargy, bad reaction at injection site. There was no treatment for AE. The outcome of events was recovered on an unspecified date in Feb2021..
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| 70 | 2021-03-20 | nausea |
nausea; low grade fever; chills; 4hrs after shot: redness at injection site; red rash about 3" in di...
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nausea; low grade fever; chills; 4hrs after shot: redness at injection site; red rash about 3" in diameter on non vaccinated arm. Rash is not itchy or raised; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9264), via an unknown route of administration on 11Feb2021 at 16:00 (04:00 PM) in Left arm at single dose for COVID-19 immunisation at Pharmacy or Drug Store. Age at vaccination was 70 years. The patient wasn't pregnant at the time of vaccination. Patient had allergies to medications, food, or other products. Other medical history included asthma. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included fluticasone propionate, salmeterol xinafoate (ADVAIR) at 250/50; lisinopril (LISINOPRIL) at 40 mg dose; salbutamol sulfate (VENTOLIN) Inhaler. The patient experienced redness at injection site 4hrs (at 20:00) after shot on 11Feb2021. On 12Feb2021 at 18:00 (06:00 PM), she experienced nausea, low grade fever, chills 24hrs after shot; on Feb2021 experienced red rash about 3" in diameter on non vaccinated arm 40hrs after shot. Rash was not itchy or raised. Patient didn't received treatment for the adverse event. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Serious was reported as no. Outcome of all events was unknown. No follow-up attempts are possible. No further information is expected.
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| 70 | 2021-03-21 | diarrhea |
Over a period of 4.5 days, fever, fatigue, joint pain, muscle pain, loose stools, general malaise ...
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Over a period of 4.5 days, fever, fatigue, joint pain, muscle pain, loose stools, general malaise My concern is that now post 23 days after 2nd vaccine, I?m still having fatigue, no endurance, mild/moderate body aches, worse at night, still some episodes of loose stools.
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| 70 | 2021-03-21 | nausea |
Vaccine given on Monday March 8 2021 second vaccine. Sunday morning March 14 woke up dizzy & nause...
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Vaccine given on Monday March 8 2021 second vaccine. Sunday morning March 14 woke up dizzy & nausea. Passed by 12noon & returned at bed time 10p Monday morning March 15woke up dizzy & nausea & passed about noon did not return. At some point Fri March 20 slight nausea upon waking from a nap. Sunday March 21 slight nausea in morning passed in afternoon.
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| 70 | 2021-03-21 | vomiting |
Within 24 hours of first shot I developed pulsatile tinnitus. Continues to present time. Within 24 ...
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Within 24 hours of first shot I developed pulsatile tinnitus. Continues to present time. Within 24 hours of second shot I developed slight dizziness/imbalance, which progressed to vertigo with vomiting 6 days after shot. At present there is still a balance issue.
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| 70 | 2021-03-22 | diarrhea, nausea |
13 hours after injection while sleeping had strong urge to go to the bathroom, bowel movement, resul...
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13 hours after injection while sleeping had strong urge to go to the bathroom, bowel movement, resulting in massive diarrhea. During process, became very dizzy and felt nauseous and faint. Attempting to get up from toilet, and getting assistance from husband in an adjoining bedroom, made it to a second bathroom, passing out, again, complete empty of bowels severe diarrhea again while passed out on floor. Unconscious for about one minute, until revived by husband. Sweating, faint, very low BP. Taken to hospital by husband after getting composure admitted for observation due to apparent dehydration from massive diarrhea event. Results possible cardiac instability, dehydration from diarrhea, vegas nerve activity with Discharge the next day 03/22/2021 with follow up with cardiac Dr and primary, ongoing
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| 70 | 2021-03-22 | nausea |
nauseous, swollen lymph nodes under right armpit, chills, fever of 102, joint pain. 5 days later sa...
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nauseous, swollen lymph nodes under right armpit, chills, fever of 102, joint pain. 5 days later same symptoms
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| 70 | 2021-03-23 | abdominal pain |
Shortness of breath, severe chest tightness started 5 to 8 minutes after the injection lasted for 5...
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Shortness of breath, severe chest tightness started 5 to 8 minutes after the injection lasted for 5 minutes and were followed by an overwhelming weakness, confusion, later also by abdominal cramps, some urinary urgency- all gradually improved over 30-40 minutes. I felt later agitated, had dry mouth, headache- improved after drinking 8-10 cups of water. I did not seek help. I stayed in the shot area in a large tent.
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| 70 | 2021-03-23 | diarrhea, nausea | Fever/Chills, Cough, Headache, Diahrrea, Dizziness, Nausea, Perspiration, Overall Weakness |
| 70 | 2021-03-23 | difficulty swallowing |
Shortly after the first dose of Pfizer vaccine, my upper lip, upper gums ,nose, eyelids got swollen...
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Shortly after the first dose of Pfizer vaccine, my upper lip, upper gums ,nose, eyelids got swollen and the back of my tongue felt sore. At 11:00 pm same day , when I went to take my low dose aspirin and vitamin D gel caps with water, I had difficulty swallowing them. The side effects lasted until the following day by early evening. I left several ,messages with VAERS, to report these symptoms and never got a call back.
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| 70 | 2021-03-23 | nausea |
Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand AllCollapse All ...
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Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand AllCollapse All COVID VACCINE CLINIC 3/24/2021 Date: 3/24/2021 Subjective is a 70 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience a change in her cough and felt nauseated. She felt better shortly after 5 minutes but then her husband noted some redness in skin color in her legs and on her abdomen. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, collapse, hypotension, rapid progression of symptoms, respiratory distress, skin changes and increased in HR. Upon arrival to bay, HR 180-190. Pt's husband states pt with hx of svt. Usually in high 200's or low 300's if it comes on. Hx of having HR in the 150s at times. Usually resolves on its own with elevation of feet above pt's head per pt's husband. He is not worried about it but wanted to know what her pressures were doing. PT with alz. Pt's husband is main caregiver. ALLERGY REVIEW OF SYSTEMS: Redness went away after sitting down.: CONT negative HENT negative Eyes negative Respiratory negative Skin negative GI negative Neuro negative Previous Reactions: none Objective Vitals Vitals: 03/24/21 1045 03/24/21 1101 03/24/21 1115 BP: (!) 141/86 124/80 124/82 Pulse: (!) 180 (!) 158 (!) 150 SpO2: 100% 100% 100% Physical Exam Constitutional: General: She is not in acute distress. Appearance: She is well-developed. Comments: Flushed appearance upon arrival to bay. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Regular rhythm. Tachycardia present. Heart sounds: Normal heart sounds. Comments: HR came down to 150-160's after Trendelenburg position. Ice pack placed on chest. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert. Mental status is at baseline. She is disoriented. Gait: Gait normal. Comments: Disoriented at baseline per pt's husband. Pt able to tell me who her husband is and their plans for cruise this summer. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Assessment/Plan Treatment included: water and Trendelenburg position Follow up response to treatment: fair. Patient discharge: AMA. Differential Diagnosis: Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Discussed pt's HR despite of pt being stable here that they ought to seek further medical care in the ED. Pt husband declines as "she's done this before and I'm not worried. We will go to the hospital if she is not getting better. I think when we get home, in her normal environment, she will be fine." He voices appreciation for our evaluation and concerns. She was able to demonstrate assistance to standing position without reports of feeling dizzy or lightheaded. Pt color does look better. Redness is gone and she continues to report to feel well. Pt wheeled out in wheelchair. Husband is aware of our recommendations. APRN Electronically Signed 3/24/2021 10:59 AM Division of Health
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| 70 | 2021-03-23 | nausea |
8 pm - hyper, frequent urination,chills,fever,nausea,weakness , feeling ?faint?. Symptoms lasted 4 ...
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8 pm - hyper, frequent urination,chills,fever,nausea,weakness , feeling ?faint?. Symptoms lasted 4 days . Then intermittent fever & chills . After 4 days red & swollen @ site of FIRST injection (NOT the 2nd injection !) . Extreme fatigue for a week .
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| 70 | 2021-03-24 | nausea |
After patient received vaccine and waited 15 minutes she asked if she could wait longer because she ...
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After patient received vaccine and waited 15 minutes she asked if she could wait longer because she didn't feel well. Paramedic was called and took patient to the EMS tent - per EMS pt was diaphoretic with hypotension and near syncope -after laying down BP normalized and pt resumed normal status. Pt requested to go to the ED. Pt is currently being treated with chemotherapy and had her last dose 5 days prior. She was brought in by EMS after appearing cool, diaphoretic, nauseous, and unwell after vaccine administration. Patient states that she was feeling nauseous, dizzy, and weak 1 hour after administration. She likely had a vasovagal-like response to vaccine administration. Did not lose consciousness.
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| 70 | 2021-03-24 | vomiting |
I had a horrible reaction to the second shot of Covid 19; I really thought I was going to die; It wa...
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I had a horrible reaction to the second shot of Covid 19; I really thought I was going to die; It was so bad; that's how bad that was; I woke up with the migraine headache, I never had a migraine; I had complete chills; I had a bad fever; I had complete exhaustion; my whole body hurt; I had complete exhaustion; my whole body hurt; I started vomiting, I had repeated vomiting; I just could not feel any worse; No, I just don't feel great yet, I lost 5 pounds truthfully; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on 16Mar2021 (at the age of 70-years-old) as single dose for covid-19 immunization. Medical history included thyroid disorder (thyroid). Concomitant medication included thyroid (NATURE THROID) for thyroid. On 17Mar2021, the patient experienced that she had a horrible reaction to the second shot of COVID 19; she really thought she was going to die; It was so bad; that's how bad that was; the patient woke up with the migraine headache, she never had a migraine; the patient had complete chills; the patient had a bad fever; the patient had complete exhaustion; her whole body hurt; the patient started vomiting, she had repeated vomiting; she just could not feel any worse. The patient stated, "No, I just don't feel great yet, I lost 5 pounds truthfully" and with treatment, the patient stated, "No, just drink water." The patient thought maybe other people were having this, were other people calling that they got that sick and the patient was not obese or anything. The patient know they make it like if they were overweight, terribly overweight, have a worse reaction, the patient was a little overweight but hardly any. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 70 | 2021-03-25 | decreased appetite |
About 5 hours after the second dose I could not stay awake. I had horrible sweats all night. The fol...
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About 5 hours after the second dose I could not stay awake. I had horrible sweats all night. The following morning my joints were stiff, and I hurt all over. I could not straighten my legs, and my fingers were curled. I could not straighten them. I had 102.2 fever, sore throat, headache, runny nose. Slept most of day 1. Day 2 I had sweats, fatigue, loss of appetite, but thought I was getting better. I was able to straighten my legs and fingers. Day 3 I still had sweats, runny nose, sore throat, headache. Ok by day 4. I did not see my dr.
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| 70 | 2021-03-25 | vomiting, nausea |
Started to not feel well 10 hours after injection. About 12 hours after the injection I had nausea,...
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Started to not feel well 10 hours after injection. About 12 hours after the injection I had nausea, vomiting, fever, headache. Symptoms ended about 24 hours after injection.
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| 70 | 2021-03-26 | nausea, diarrhea | Within 15 minutes of injection experienced cramping, diarrhea and nausea. Observed for 30 minutes. |
| 70 | 2021-03-26 | nausea |
I took the vaccine at 11:20 a.m. on Thursday 3/25/21. About 3:00 a.m. I awoke with a splitting head...
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I took the vaccine at 11:20 a.m. on Thursday 3/25/21. About 3:00 a.m. I awoke with a splitting headache, my night gown was soaked with sweat, I ached all over and I was nauseated. Walking to the bathroom was painful. I took two Tylenols These symptoms continued throughout the day on Friday. I awoke Saturday free of symptoms.
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| 70 | 2021-03-27 | decreased appetite |
Temperature high=104 decreasing each hour over 8 hours Extreme coldness for an hour subsiding over ...
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Temperature high=104 decreasing each hour over 8 hours Extreme coldness for an hour subsiding over 8 hours Muscle & joint ache Headache...at times like migraine with light sensitivity VERY TIRED Loss of appetite Disorientation Off balance
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| 70 | 2021-03-27 | vomiting, decreased appetite | Chills, cough, sweats, runny nose, vomiting, loss of appetite, sneezing, headaches |
| 70 | 2021-03-28 | difficulty swallowing |
Sitting in the waiting room after the shot, I started to experience difficulty swallowing about 15 m...
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Sitting in the waiting room after the shot, I started to experience difficulty swallowing about 15 minutes after shot followed by tingling around both upper & lower lips. Doctor on site saw that I was having an event which he thought was either a TIA or Stroke because my smile was crocked, lip was drooping and BP was very high. The doctor ordered an Ambulance who transported me to hospital as the doctor said they were equipped to handle such an event as they are a Trauma 1 hospital.
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| 70 | 2021-03-30 | nausea |
Tired; headache; chills; fever; nausea; dizziness; weakness; body shook; This is a spontaneous repor...
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Tired; headache; chills; fever; nausea; dizziness; weakness; body shook; This is a spontaneous report from a contactable 70-year-old female consumer (patient, non-pregnant) received second dose BNT162B2 (Solution for injection, brand: Pfizer, lot number: EL3246) via an unspecified route of administration in Arm Left on 23Jan2021 at 08:15 AM for COVID-19 immunization. Patient medical history included High BP, Hyatal hernia. Concomitant medications included fish oil, atenolol, omeprazole, ascorbic acid, calcium, minerals nos, retinol, tocopheryl acetate, vitamin b nos, vitamins nos, zinc (CENTRUM SILVER). Patient previously took rosa canina (ROSE HIPS, need to take over time) and had allergy. Historical vaccine included first dose BNT162B2 (COVID19, brand: Pfizer, lot number: EK9231) on 02Jan2021 at 08:45 AM on Left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 23Jan2021 20:45, patient had tired, headache, chills, fever, nausea, dizziness, weakness body shook for about a hour and half. No Seriousness criteria was reported. Outcome of events was recovering.
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| 70 | 2021-04-06 | flatulence, decreased appetite, abdominal pain, diarrhea |
fatigue; mild diarrhea; abdominal pain; gas; runny nose; diarrhea with blood; Sneezing; watery eyes;...
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fatigue; mild diarrhea; abdominal pain; gas; runny nose; diarrhea with blood; Sneezing; watery eyes; orange bowel movement; near syncope; lightheaded/lightheadness; chills; body aches; decreased appetite/poor appetite; This is a spontaneous report from a contactable Other-HCP (healthcare professional) in response to HCP letter sent in cross reference case. A 70-year-old female patient received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH; Lot Number: EN6201) intramuscularly on 05Mar2021 (at the age of 70-years-old) as a single dose in the deltoid left for COVID-19 immunisation. Medical history included ongoing HTN (hypertension; onset date: years ago; pertinent details: well controlled) from an unspecified date and menopause from an unspecified date and unspecified if ongoing. Concomitant medications included ongoing hydrochlorothiazide orally taken for HTN from an unspecified date, ongoing estradiol benzoate (ESTRADIOL) vaginal taken for menopause from an unspecified date and ongoing multivitamin orally taken for health maintenance from an unspecified date. The patient previously received the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH; Lot Number: EL9261) intramuscularly on 12Feb2021 as a single dose in the deltoid left for COVID-19 immunisation and experienced sore arms and should injury. Prior vaccinations were reported as none. On 07Mar2021 the patient experienced diarrhea with blood (medically significant), sneezing, watery eyes, orange bowel movement, on 06Mar2021 the patient experienced near syncope, lightheaded/lightheadness, chills, body aches and decreased appetite/poor appetite, on 08Mar2021 the patient experienced fatigue, mild diarrhea, abdominal pain, gas and runny nose. It was reported that the event near syncope was non-serious, did not require treatment. It was also reported that the events near syncope and diarrhea with blood required a visit to the emergency room. The clinical course was reported as follows: "05Mar2021 Vax. 06Mar2021- Lightheadedness onset day after COVID vax #2. Lightheaded, chills, body aches, decreased appetite. 07Mar2021- Sneezing, watery eyes, orange bowel movement, poor appetite, diarrhea with blood. To ER. 08Mar2021- Fatigue, poor appetite, mild diarrhea, abdominal pain and gas, sneezing, runny nose. 09Mar2021- Improved." The patient underwent lab tests and procedures on 07Mar2021 that included: EKG, CBC and comprehensive metabolic panel which were all normal. The clinical outcome of the event near syncope was recovered/resolved on an unspecified date while the clinical outcomes of the events diarrhea with blood, lightheaded/lightheadness, chills, body aches, decreased appetite/poor appetite, sneezing, watery eyes, orange bowel movement, fatigue, mild diarrhea, abdominal pain, gas and runny nose were all unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Diarrhea bloody cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 70 | 2021-04-06 | nausea |
Tiredness; Headaches; Chills; Fever; Nauseated; Dizziness; Weakness; felt sick; can't see as good, h...
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Tiredness; Headaches; Chills; Fever; Nauseated; Dizziness; Weakness; felt sick; can't see as good, her eyes are weak; Difficulty breathing; thought she was having a heart attack; dehydrated; fast heart beat that felt like her chest was full; fast heart beat that felt like her chest was full; Injection Site Pain; blood pressure fluctuated; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 27Feb2021 12:00 (lot number: EN6202; expiration date: 30Jun2021) as single dose for COVID-19 immunisation. Medical history included ongoing high blood pressure and stroke from 2012 to an unknown date. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN) taken for stroke from 2012 and ongoing; clopidogrel bisulfate (CLOPIDA) and simvastatin both taken for high blood pressure from 2012 and ongoing; ongoing amlodipine, lisinopril, and metoprolol all taken for high blood pressure. On 27Feb2021, she took the first vaccine. From that day, for 2 days, she had injection site pain. On 07Mar2021, she started having tiredness, headaches, chills, fever, felt nauseated, had a fast heart beat that felt like her chest was full and thought she was having a heart attack, dizziness, weakness, felt sick, and difficulty breathing. The patient added that she can't see as good, her eyes are weak. She was going to make an appointment to get her eyes checked. For dizziness event, she has to sit on the side of her bed for 10 minutes and she was still dizzy. She has to hold on to something because she feels like she is going to fall. She was given meclizine three times a day for this event. For tiredness event, she stated that it fluctuates during day. After she takes a paracetamol (EXTRA STRENGTH TYLENOL) and lays down for a while, she feels ok and then she feels tired again. For fast heart beat that felt like her chest was full and thought she was having a heart attack event, it comes and goes, she had it yesterday (21Mar2021) but hasn't had it today (22Mar2021) but she doesn't know if it is gone. Her symptoms were usually in the morning when she first gets up. She has been to the emergency room (ER) on 07Mar2021 and on 13Mar2021 and they say that nothing is wrong. On 07Mar2021, they gave her an IV because they thought she was dehydrated. On 13Mar2021, she went back to another hospital ER. She felt worse and her son came and got her and took her to the ER. They did a whole workup MRI of her head, x rays, blood work and everything. They didn't know what was causing it because it had it been over a week since her vaccine and they sent her home. She has been laying down and staying hydrated. She couldn't hardly get up and they asked her what has she done different and the only thing different was the vaccine. Everything listed on the risk factors [side effects] is how she is feeling. She was not hospitalized, they gave her medicine and told her to stay hydrated and sent her home and was told to follow up with her physician. She finally got an appointment for tomorrow (23Mar2021) with her physician. She can't drive because of the dizziness. All of her tests came back normal. They said her blood pressure fluctuated on 2021 but that is normal. Outcome of the injection site pain was recovered on 01Mar2021, of the difficulty breathing was recovering, of the headache, chills, fever, dizziness, weakness, and felt sick was not recovered, while of the remaining events was unknown.
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| 70 | 2021-04-06 | vomiting, nausea |
4:30pm slight nausea; arm pain; mild headache 5:00 pm headache more severe; up the back of head, des...
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4:30pm slight nausea; arm pain; mild headache 5:00 pm headache more severe; up the back of head, described as unusual pain; thought a migraine was coming on. 5-7:00pm headache continues to worsen; chills; research on line side effects of Pfizer vaccine and they coincide with symptoms; 7:05 gets up to urinate (no assistance needed); screams out in pain 3 times while on toilet; starts to vomit; right side of face (eye and cheek and mouth droop like a stroke; left hand starts to curl. Loses consciousness immediately thereafter. 911 call; paramedics on the way; airway was swept and clear; gurgled breathing. Rushed to Hospital and assessed as having massive brain bleed. Pronounced dead at 10:22pm. Acute Hemorrhagic Stroke on Death Certificate.
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| 70 | 2021-04-06 | vomiting |
excess vomiting about 10 times in 5 hours; Very high fever; This is a spontaneous report from a cont...
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excess vomiting about 10 times in 5 hours; Very high fever; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 19Mar2021 10:30 (Batch/Lot Number: Unknown) as single dose for covid-19 immunization at a clinic. Medical history included asthma, high blood pressure and allergy with Sulfa. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ), fluticasone propionate, salmeterol xinafoate (ADVAIR HFA) and apple cider vinegar. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Feb2021 at 10:00 in the left arm for covid-19 immunisation. The patient experienced very high fever and excess vomiting about 10 times in 5 hours on 19Mar2021 at 22:00. No treatment was given for the events. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was recovered on an unspecified date. Information on the lot/batch number has been requested.
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| 70 | 2021-04-09 | abdominal pain upper, decreased appetite |
loss of appetite; pretty bad headache; body aches; tightness in her chest; Ringing in ears; stomach ...
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loss of appetite; pretty bad headache; body aches; tightness in her chest; Ringing in ears; stomach cramps; slept 15 hours; lump; pimple; infection on the abdomen; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, in Arm Left on 24Feb2021 (Lot Number: EN6202) as SINGLE DOSE for COVID-19 immunization. Medical history included a lot of allergies from an unknown date and unknown if ongoing. Concomitant medications included losartan taken for high blood pressure, start and stop date were not reported; formoterol fumarate, mometasone furoate (DULERA) taken for bronchial hyperreactivity, start and stop date were not reported; fluticasone to help her breathe, start and stop date were not reported; fexofenadine a decongestant for allergies, start and stop date were not reported; tolnaftate antifungal solution for toenail, start and stop date were not reported; and fluorometholone taken for plugged up tear duct, start and stop date were not reported. The patient previously had flu shot once about 15 years ago and it was terrible. With the first dose, the patient started to have loss of appetite, pretty bad headache, body aches, tightness in her chest, ringing in her ears, and stomach cramps. She slept 15 hours the first night. She got up to go the bathroom and then went right back to bed. That happened after first dose and she wasn't too anxious to get the second dose. These were pretty strong. For 24 hours after onset they were pretty severe. Then she experienced variation of these and lessening of severity over seven days. By the next Wednesday she felt her normal self. She got both shots on Wednesday. She didn't have fever or any other problems that COVID people get. The patient had an infection on the abdomen. She took Cephalexin for 10 days. The infection on the abdomen started in early Mar2021. It was like a lump in Mar2021. She went to the dermatologist because there is cancer in her family. The dermatologist told her not to worry. Then it erupted like a big pimple in Mar2021. The outcome of the events was unknown. Follow-up attempts are needed. Information on lot/batch number is available.
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| 70 | 2021-04-09 | diarrhea, vomiting, nausea |
Very difficult to fall asleep that evening; Passed out in bed; nausea/queasy; simultaneously had dia...
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Very difficult to fall asleep that evening; Passed out in bed; nausea/queasy; simultaneously had diarrhea and vomiting (several times in a row).; simultaneously had diarrhea and vomiting (several times in a row).; headache; Slept all day; sore arm; chills; very tired; Fever about 100.5/temp now almost 101; This is a spontaneous report received from a contactable consumer (patient) reported for herself. A 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER2613) via unspecified route of administration in left arm on 23Mar2021 09:30 AM at single dose for COVID-19 immunization. Medical history included prone to bronchitis with bad cold. Known allergies included strong reactions to oxycodone hydrochloride;paracetamol (PERCOCET), zolpidem tartrate (AMBIEN) and some anesthesias. Patient did not have COVID prior vaccination, did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. Concomitant medications included rosuvastatin, loratadine, ergocalciferol (VIT D) and multi-vitamin. The patient previously received first dose of BNT162B2 (lot number: EN6205) in left arm on 01Mar2021 09:30 AM for COVID-19 immunization. Evening of the shot on 23Mar2021 07:30 PM, patient experienced sore arm, chills, later and very tired. Fever about 100.5. Middle of night, about 16-17 hrs after shot (24Mar2021) awoke with nausea. Rose to go to bathroom and simultaneously had diarrhea and vomiting (several times in a row). Extreme tiredness and nausea. About 4:30 took 2 paracetamol (TYLENOL) and anti-nausea med. Passed out in bed on 24Mar2021. Woke about 11:30 AM. temp now almost 101, headache, paracetamol and more anti-nausea med. Slept all day until 10:45 PM 24Mar2021 fever normal, nausea gone, quite tired still. On 25Mar2021, patient was able to get up, still tired but so much better, stomach still queasy. Ate bit of toast, later, rice and applesauce. Bit of headache took paracetamol. Very difficult to fall asleep that evening (25Mar2021), awoke 26Mar2021 and fell so much better although stomach still a bit queasy. Treatment was received for all events. Patient had not tested COVID post vaccination. The outcome of events was recovering.
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| 70 | 2021-04-13 | vomiting, diarrhea |
Got 2nd dose of Pfizer 3/31 3 days later SOB 1 week after vax admitted for CHF exacerbation, vomitin...
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Got 2nd dose of Pfizer 3/31 3 days later SOB 1 week after vax admitted for CHF exacerbation, vomiting and diarrhea
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| 70 | 2021-04-15 | diarrhea |
Patient is a 70 year old female with a PMH of TBI with residual memory loss, visual deficits and uns...
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Patient is a 70 year old female with a PMH of TBI with residual memory loss, visual deficits and unsteadiness who was admitted on 2/18/2021 with diarrhea and weakness. Patient tested positive for COVID-19 on 2/18/2021. She was not hypoxic and CRP was mildly elevated. Steroids and remdesivir were not indicated during the admission. Diarrhea improved overnight with IV fluids. Patient was discharged to home on 2/19/2021
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| 70 | 2021-04-15 | nausea |
Day of shot #2 (3/31/21) I experienced nausea in the first 15 minutes and felt confused while drivin...
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Day of shot #2 (3/31/21) I experienced nausea in the first 15 minutes and felt confused while driving. Nausea passed in 2-3 hours and I felt fine. The next day I felt tired, foggy brain, and dizzy. Assumed it was from the shot. Side effects continued/worsened. 4/6/21 I saw my Dr. She checked me over, labs. found nothing wrong with me. Likely side effects from Pfizer. Unlikely that they would last two weeks. Rx Meclizine for dizziness, which didn't really help. Now it's Day 15. Tired and brain fog are gone. I don't feel as dizzy. BUT, when I try to drive, I feel QUITE dizzy with blurred vision. This side effect persists and clearly effects my quality of life.
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| 70 | 2021-04-15 | nausea |
Immediate headache, heart racing, weakness, chest sensations, palpitations, nausea, After two weeks...
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Immediate headache, heart racing, weakness, chest sensations, palpitations, nausea, After two weeks of continued symptoms suddenly had Afib with RVR event and went to Er
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| 70 | 2021-04-17 | abdominal pain upper |
Lower chest partial atelectasis or scarring in the lung bases bilateral; Partial lung collapse (both...
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Lower chest partial atelectasis or scarring in the lung bases bilateral; Partial lung collapse (both upper and lower parts collapsed); Lower chest partial atelectasis or scarring in the lung bases bilateral; Beneath this area was a red circle where blood clotted or something; Wheezing; Shortness of breath; Swelling of the face; underneath the arm where the injection site was, a big red circle was noted and it was swollen/under her nose and left elbow were red; underneath the arm where the injection site was, a big red circle was noted and it was swollen; I would get hot and cold; I was sweating; Pain in her chest, stomach, back and head; Pain in her chest, stomach, back and head; Pain in her chest, stomach, back and head; Pain in her chest, stomach, back and head; Fatigue; Pain in left elbow; goes to bathroom and bowel was not emptying the way it should; rib cage is going on the side of body noticed this thumping; Her lips were red; Throat was red; Been sick and just laying around; Her eyes were red; Cramp in left arm where site of injection; Sharp pains were hitting her in her eye, thigh, chest, head, and the arm; Sharp pains were hitting her in her eye, thigh, chest, head, and the arm; This is a spontaneous report received from contactable consumer (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 15Mar2021 (at the age of 70 years) at a single dose in the left arm for COVID-19 immunization. Medical history included lung issues and allergic asthma. Family history included brothers and sisters who died of lung issues and third sibling sister died many years ago due to allergic asthma. The patient previously took flu vaccine for immunization and experienced severe pain throughout her whole body. On 15Mar2021, patient received the first dose of Pfizer COVID-19 vaccine. Later on, that day when she got home after receiving the vaccine, underneath the arm where the injection site was, a big red circle was noted and it was swollen, beneath this area was a red circle where blood clotted or something, she would get hot and cold and take her clothes off because she was sweating but did not have fever, there was pain in her chest, stomach, back and head, wheezing, shortness of breath, fatigue, swelling of the face, pain in left elbow. She goes to bathroom and bowel was not emptying the way it should. She also noted that her rib cage is going on the side of body noticed this thumping, lips and throat were red. She's been sick and just laying around, her eyes, under her nose and left elbow were red, had cramp in left arm where site of injection, and sharp pains were hitting her in her eye, thigh, chest, head, and the arm. Patient clarified that these symptoms began on 15Mar2021, the same day she received the Pfizer COVID-19 vaccine. On 23Mar2021, patient went to the ER and the findings were lower chest partial atelectasis or scarring in the lung bases bilateral and partial lung collapse (both upper and lower parts collapsed). At the hospital her temperature was 98.9 F on 23Mar2021, but 97.1F - 97.7F is her normal temperature. She went to the Pulmonary doctor also, but was getting a second opinion because she knew it could be life threatening. The pulmonary doctor made light of it saying they were just creases, like creases in pants. Patient said crease was a far cry from partial lung collapse on both bases and the Pulmonary doctor also said that it is in the upper part of the lung also. This scared her and made her think nobody cared. She did not know if she should provide the information because the doctor did not seem to believe that that her symptoms were coming from receiving the Pfizer COVID-19 vaccine. She guessed she should provide the information because Pfizer does research. She wanted to know how long do the side effects last and if she should take the second dose. The outcome of the events underneath the arm where the injection site was, a big red circle was noted and it was swollen/under her nose and left elbow were red, pain in her chest, stomach, back and head, wheezing, shortness of breath, fatigue, swelling of the face, pain in left elbow, goes to bathroom and bowel was not emptying the way it should, rib cage is going on the side of body noticed this thumping, lips were red, throat was red, been sick and just laying around, eyes were red was not recovered; while unknown for the other events. Information on the lot/batch number has been requested.
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| 70 | 2021-04-27 | nausea |
feel strange; rash; throat is not closing; and it was itchy on her arm at the injection site; hard a...
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feel strange; rash; throat is not closing; and it was itchy on her arm at the injection site; hard and hot beside the site of injection; woke up this morning with a patch that was 1.5 wide by about 2 inches wide that was raised, red, hot to the touch, and it was itchy on her arm at the injection site; General malaise; Nausea; Headache; This is a spontaneous report from a contactable consumer (Patient). This 70-year-old female consumer reported for herself that she received the first dose of BNT162B2 (PFIZERBIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9262; Expiry date: unknown) via intramuscular route, administered in right arm as a single dose (at the age of 70-year-old) for COVID-19 immunization. The patients past medical history included Cesarean section (Had 3 of them. Caller said that did well with anesthesia and had no reactions), cataract removal (First was on 24Nov2020 and the second 01Dec2020. Caller said that did well with anesthesia and had no reactions), Hysterectomy (Caller said that did well with anesthesia and had no reactions), Foot surgery (Caller said that did well with anesthesia and had no reactions), cataract removal on 01Dec2020. The patient was allergic to Penicillin and tetracycline. The patient allergic to Keflex and had a rash. Tetracycline she had in her 30's got a shooting pain in her left arm and got another shooting pain in her left arm when she took tetracycline again. She had no other allergies aside from ragweed. She said that she had the Penicillin when she was a kid and Keflex as a young adult. Caller does not have the NDC, Lot, or expiration dates for the Penicillin, tetracycline, or Keflex. Lot: SBF021, exp:Aug2021. The only other time that this happened was 2 years ago when she got her flu shot and the year before that. The first year it was mild reaction and 2 years ago it was the size of a golf ball. This year she had nothing from the flu shot. She took Benadryl last night and was surprised when she saw that this morning. It usually wards off any allergy attack. She did not take a whole one and stated that it knocks her out so she only took a half. The patient said that she took a Advil every 4-6 hours and attributed the well being to that. The patients concomitant medications was not reported. The patient was calling about the COVID-19 Vaccine and said that she received the first shot on 20Jan2021. She said that everything had been fine until this morning and it had been 2 weeks. She had no sore arm. On 20Jan2021, patient experienced a headache for a minute for like 2 days. On 21Jan2021, she had nausea lasted a few minutes then it was gone. Caller said that her headache and nausea symptoms were so fleeting that she did not even report it. She said that it was so mild that it was almost insignificant it was so mild. She said that she did report it at the safety reporting system and at the (Website name) for the vaccination check in. One day on an unspecified date, she did feel strange and on 22Jan2021 she had general malaise, she just felt something was wrong and it lasted about 30 minutes. She said that it was a general feeling that she was not well. She said she took a Advil and ignored it. The patient clarified that last night she started scratching underneath her ear, thought she was going to have a break out, but on 04Feb2021, she woke up this morning with a patch that was 1.5 wide by about 2 inches wide that was raised, red, hot to the touch, and it was itchy on her arm at the injection site. She said that it is no where else, no else on her body. On an unknown date, she felt fine and her throat was not closing and she was not having any trouble breathing or anything. She stated that the spot under her ear was gone. She put Neosporin on it. It was gone this morning. She said that this place on her arm was more of a hard place and a rash now on an unspecified date. She knows the body remembers and years down the road you could get a pain from a injury or surgery. Last night she felt a sharp pain in her right arm. She ignored it and this morning she woke up with this. It is not as hot or red, but it is still raised. The clinical outcome for the events headache recovered on 21Jan2021, nausea recovered on 22Jan2021, general malaise was recovered on 23Jan2021. The outcome for woke up this morning with a patch that was 1.5 wide by about 2 inches wide that was raised, red, hot to the touch, and it was itchy on her arm at the injection site was recovering. The clinical outcome for the other events was unknown.
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| 70 | 2021-05-04 | nausea |
I awoke at 3:15 am, with my face swollen, including eyes, cheeks, below jaw line and lips.; Minor he...
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I awoke at 3:15 am, with my face swollen, including eyes, cheeks, below jaw line and lips.; Minor headache; slight nausea; This is a spontaneous report received from a contactable consumer. A 70-year old-female patient received first dose of bnt162B2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EM9809) via an unspecified route of administration on left arm on 22Feb2021 at 21:00 as single dose for covid-19 immunization. Concomitant medications included: Calamine lotion, benefiber, calcium600/vitamin D. Medical history included allergies to Penicillin, statins, metals. The patient underwent lab tests and procedures, which included elbow replacement on an unspecified date in 2016. It was reported that 18 hours after injection, on 23Feb2021 at 3:15 am, patient woke up with face swollen, including eyes, cheeks, below jaw line and lips. There was no indication of swollen tongue, no difficulty breathing or swallowing. Minor headache and slight nausea. The adverse events required emergency room visit. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. The patient didn't receive other medication in two weeks. Therapeutic measures were taken as a result of events and included treatment with: Benadryl, Famotidine. Outcome of the events was recovering
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| 70 | 2021-05-05 | vomiting, nausea |
Extreme dehydration; Nausea; Vomiting; Severe ataxia; mad global cortical atrophy; This is a spontan...
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Extreme dehydration; Nausea; Vomiting; Severe ataxia; mad global cortical atrophy; This is a spontaneous report from a contactable nurse (patient). A 70-year-old female patient received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN6207) at single dose, in the right arm, on 11Mar2021, for COVID-19 immunisation. Relevant medical history included Sjogren's disease form an unspecified date. The patient previously, on 18Feb2021, at 11:45 AM, at the age of 70 years, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN6200) at single dose, in the left arm, for COVID-19 immunisation. On 24Feb2021, at 11:00 PM, the patient experienced an unspecified adverse event. Concomitant medications included levothyroxine 112 ug, from an unspecified date, for an unknown indication. On 16Mar2021, mad global cortical atrophy was reported. On 27Mar2021, the patient experienced extreme dehydration, nausea, vomiting and severe ataxia. Physician Office Visit and Emergency Room Visit were required. The patient received on 27Mar2021 normal saline (NS) 2L in ER over 2hr for extreme dehydration, nausea, vomiting and severe ataxia. Relevant laboratory tests included computerised tomogram (CT scan w/o contrast) on 12Mar2021: multifocal to confluent areas of decreased attenuation in the deep white matter ascending into the basal ganglia consistent with mod severe small vessel ischemic/degenerative finalizing; Magnetic resonance imaging head (MRI Brain w/o contrast) on 16Mar2021: no acute findings. Mad global cerebral atrophy and severe renascent small vessel ischemic white matter disease; MRI Neck on 16Mar2021: unremarkable and MRI Head w/o contrast on 18Mar2021: unremarkable. Clinical outcome of the events was unknown at time of this report.; Sender's Comments: Based on the information currently available causality between reported events and suspet product BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
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| 71 | 2021-01-05 | abdominal pain, vomiting, nausea |
Abdominal pain, chills, n/v, dark urine, elevated LFT's, Bilirubin in urine. Patient currently admit...
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Abdominal pain, chills, n/v, dark urine, elevated LFT's, Bilirubin in urine. Patient currently admitted to hospital
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| 71 | 2021-01-12 | diarrhea | Bad cough and explosive diahrea |
| 71 | 2021-01-13 | nausea |
mild nausea; dizziness/dizzy; This is a spontaneous report from the Pfizer-Sponsored program, recei...
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mild nausea; dizziness/dizzy; This is a spontaneous report from the Pfizer-Sponsored program, received by a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number E10142), via an unknown route, on 04Jan2021 at single dose in the left arm for COVID-19 immunisation. The patient received tetanus vaccine (at single dose in the right arm for tetanus immunization, due to overdue) in Dec2020 (3-4 weeks before vaccination for COVID-19). No additional medical history was provided. No relevant concomitant medications were provided. On 06Jan2021, she developed dizziness, she started feeling dizzy. On 07Jan2021, the patient developed mild nausea to the point that if she was laying on her right to turn on her left that her head was dizzy. The patient stated that she could not go in the bathroom at all last night because she could not make it due to dizziness. She stated that she had to pee in a cup. The patient reported that her niece, aged 27, with a history of vertigo also experienced severe dizziness after her first shot (reported under AER#2021015495). The patient had recovered from mild nausea on 07Jan2021 while she was recovering from dizziness/dizzy.
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| 71 | 2021-01-14 | abdominal pain upper, diarrhea |
chills; stomach cramps; watery diarrhea all day and through the evening; This is a spontaneous repor...
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chills; stomach cramps; watery diarrhea all day and through the evening; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number EK9231 and expiry date unknown) via an unspecified route of administration in the left arm on 07Jan2021, 12:15PM at a single dose for COVID-19 immunization. The patient's medical history included allergy to scallops. Concomitant medications included metoprolol, omeprazole, simvastatin, magnesium chloride (SLOW MAG), and colecalciferol (VITAMIN D); patient also receive these medications within 2 weeks of vaccination. The patient had previous allergies with Erythromycin. The patient was not pregnant; did not receive any other vaccines within 4 weeks prior to BNT162B2; and was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On Sunday, 10Jan2021, 1200AM, reported as three days after vaccine, the patient developed chills, stomach cramps, and watery diarrhea all day and through the evening. No therapeutic measures were taken in response to the events. Outcome of the events at the time of last observation was recovering. The report was considered as non-serious; the events did not result in death, were not life threatening, did not caused/prolonged hospitalization, were not disabling/ incapacitating, and did not caused any congenital anomaly/birth defect.
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| 71 | 2021-01-14 | vomiting |
Headache, vomiting, chills, dizziness 24 hour bed rest and Tylenol 1/15/2021, still light headed and...
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Headache, vomiting, chills, dizziness 24 hour bed rest and Tylenol 1/15/2021, still light headed and slightly dizzy
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| 71 | 2021-01-15 | nausea |
1/15/2021, 8:15 AM Approx. 10 minutes after arising, experienced dizziness, nausea, unwell feeling,...
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1/15/2021, 8:15 AM Approx. 10 minutes after arising, experienced dizziness, nausea, unwell feeling, cold sweat. Lasted approx. 20 minutes. Resolved after lying down..
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| 71 | 2021-01-19 | abdominal pain upper |
Pt admitted to hospital on 1/4 with epigastric abd pain and tested positive for COVID. Discharged to...
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Pt admitted to hospital on 1/4 with epigastric abd pain and tested positive for COVID. Discharged to recover at home on 1/6. Presented to different hospital 1/12 with progressive SOB. Remains admitted, being treated for Acute on chronic respiratory failure with hypoxia due to COVID-19 pneumonia.
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| 71 | 2021-01-19 | diarrhea, vomiting |
Vomiting , diareeah, nauaea. lots of sinus drainage. overall tiredness. lasted a day . feeling bet...
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Vomiting , diareeah, nauaea. lots of sinus drainage. overall tiredness. lasted a day . feeling better but not 100%.
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| 71 | 2021-01-19 | nausea |
Pt reported feeling some nausea approx 10 minutes post injection, along with feeling hot. Pt denies ...
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Pt reported feeling some nausea approx 10 minutes post injection, along with feeling hot. Pt denies vomiting, denies shortness of breath, rash/hives, difficulty swallowing and other symptoms. Pt reports a single reaction to an antibiotic in the past, denies Hx of vaccine reactions. Pt states she feels cooler after removing two of her three long sleeve layers. Nausea treated with 8mg ODT ondansetron, with noted relief.
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| 71 | 2021-01-20 | abdominal discomfort | COMPLAINT OF FEELING DIZZY, STOMACH UPSET ON 1/16/2021 SAW FAMILY DOCTOR ON 1/20/2021 HAD |
| 71 | 2021-01-20 | nausea, diarrhea, nausea, diarrhea | 1/20/21 HA, fever, chills, fatigue, pain and swelling at site, nausea and diarrhea |
| 71 | 2021-01-20 | vomiting, diarrhea, nausea |
Arm, shoulder and lower back pain, bodyaches, diarrhea, nausea, vomiting, fatigue, weakness on day a...
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Arm, shoulder and lower back pain, bodyaches, diarrhea, nausea, vomiting, fatigue, weakness on day after vaccine; fatigue and weakness on day 2 after.
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| 71 | 2021-01-21 | nausea |
Very tired after vaccination. Went to sleep about 8 PM Sat 1/16 and slept most of the next 4 days. ...
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Very tired after vaccination. Went to sleep about 8 PM Sat 1/16 and slept most of the next 4 days. Stomach was queasy. Unable to drink coffee. Tried to push fluids and tried to just eat bland foods. Would wake up sporadically but was unable to awaken enough to watch an entire TV show. Pretty lethargic and brain fog. Was able to wake up a little more on Wed 1/20 but still had the queasy stomach. Started getting Headache and Eye pain and severe upper leg and lower back burning & cramping, I tried taking tylenol which helped a little. By Thursday the pain was worse. I was still tired only walking helped the pain. It got worse if I sat down and extremely bad if I laid down to try to sleep. It's Friday morning & I am planning to go to med check this AM. Symptoms still ongoing
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| 71 | 2021-01-24 | nausea |
Extremely unusual pain at injection site, (compared to any other past injections) generally achey, ...
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Extremely unusual pain at injection site, (compared to any other past injections) generally achey, headache, occasional waves of nausea, fever 100.4, fatigue (stayed in bed most of the day). There was one occasion where my left hand had a strange involuntary "twitch". I only mention that because on Saturday (1/23/21) i had a few episodes of speech difficulty (words "not coming out right")
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| 71 | 2021-01-25 | nausea |
Pt was sitting in observation area after vaccine administation and reported feeling "woozy" to RN at...
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Pt was sitting in observation area after vaccine administation and reported feeling "woozy" to RN at 0920. Pt reported mild nausea and lightheadedness, denies any other sxs. RN requested assistance from site lead and RN sat with Pt for about 5 min and instructed to take slow breathes then walked Pt closer to nurse's station. Pt reported feeling some anxiety but was starting to feel better after sitting near RN. Advised Pt to stay for 30 min observation instead of 15 min and Pt agreed. At 0944 Pt reported all sxs had resolved and ambulated out of building with steady gait in stable condition.
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| 71 | 2021-01-25 | nausea |
Nausea, low grade fever, oxygen fluctuating- dropping in 60s. She normally takes oxygen only at ni...
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Nausea, low grade fever, oxygen fluctuating- dropping in 60s. She normally takes oxygen only at night at 1L/hour. She went home from work today and placed her oxygen on at 1 L/hour, increased her prednisone to 20 mg daily from 10 mg daily and performed ipatroprium nebs three times daily.
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| 71 | 2021-01-26 | nausea |
Nausea; Chills; Sweating; General unwell feeling; This is a spontaneous report from a contactable co...
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Nausea; Chills; Sweating; General unwell feeling; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via an unspecified route of administration at the right arm on 11Jan2021 13:45 at a single dose for covid-19 immunization. Medical history included allergic to shellfish and allergic reaction to bee sting 50 years ago. Concomitant medication included losartan potassium (strength: 100 mg) and atorvastatin calcium (ATORVA). The patient experienced nausea, chills, sweating and general unwell feeling on 13Jan2021 12:15. The patient took two paracetamol (TYLENOL) as treatment for the events. The patient was not pregnant at the time of administration. Outcome of events was recovering.
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| 71 | 2021-01-26 | nausea | Mild fever, nausea headache, extreme fatigue, muscle ache, stuffy nose, sore throat, sore arm |
| 71 | 2021-01-26 | stomatitis | Oral viral tongue and mouth sores for 1+ weeks. |
| 71 | 2021-01-27 | vomiting, decreased appetite |
Chills began at 11:15p, by morning 1/27/2021 I had a fever of 101.1. Stiffness in joints, couldn't w...
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Chills began at 11:15p, by morning 1/27/2021 I had a fever of 101.1. Stiffness in joints, couldn't walk without losing balance in early a.m. No appetite. Vomited in early afternoon. Just a very sick feeling. Began feeling better during evening. Was just able to tolerate drinking water. Today (1/28)temp is 98.1. Feeling better, just a little weak.
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| 71 | 2021-01-28 | decreased appetite | Did not feel like eating for the dinner meal. She ate some of a baked potato and diet coke. |
| 71 | 2021-01-28 | gastrointestinal pain, diarrhea, nausea |
Intestinal cramps; urgency to go to the bathroom/the urgency is almost like diarrhea; nausea; sore a...
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Intestinal cramps; urgency to go to the bathroom/the urgency is almost like diarrhea; nausea; sore arm; This is a spontaneous report from a contactable consumer via the Pfizer-sponsored Program. A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231, expiration date 30Apr2021) on her left deltoid, intramuscular on 14Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported by the patient that she is having intestinal cramps since last night. The patient also said that she is also experiencing nausea, urgency to go to the bathroom (the urgency is most likely diarrhea), and she has a sore arm; all on 14Jan2021. The outcome of the events was not recovered.
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| 71 | 2021-01-29 | diarrhea |
FEVER, FATIGUE AND DIARHEA I TOOK TYLENOL AND RESTED FOR 36 HOURS FEVER AND FATIGUE BOTH WENT AWAY ...
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FEVER, FATIGUE AND DIARHEA I TOOK TYLENOL AND RESTED FOR 36 HOURS FEVER AND FATIGUE BOTH WENT AWAY STILL HAVE MINOR DIARHEA OCCASIONALLY
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| 71 | 2021-01-30 | decreased appetite |
This was my second dose. After the first dose, I only had a sore arm. This time, about 12 hours afte...
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This was my second dose. After the first dose, I only had a sore arm. This time, about 12 hours after receiving the shot, I began to feel aches and pains (like a cold was coming on). During the night I had some chills and the next day I was very achy and very tired. I napped about 4 hours during the day and was asleep by 8p.m. and slept for 12 hours. The next day (second day after the shot), the aches receded but I was still very lethargic for about another 8 hours. I began to feel 'normal' by evening and am felling OK today (third day after the shot). I did drink a lot of water during the whole time as I felt very thirsty (and I am normally a big water drinker!) I also had no appetite until this morning.
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| 71 | 2021-01-30 | nausea |
Severe head pain, not a headache, severe throbbing searing pain in the head, causing nausea still pr...
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Severe head pain, not a headache, severe throbbing searing pain in the head, causing nausea still present 14 hours after the head pain started
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| 71 | 2021-01-31 | abdominal discomfort | Fever, headache, upset stomach |
| 71 | 2021-01-31 | nausea, vomiting |
nauseous; threw up all day; heart races a little bit in the middle of the night/her heart also went ...
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nauseous; threw up all day; heart races a little bit in the middle of the night/her heart also went racing a few times in the night; sinus pain; dizziness/like she was not dizzy today like she was yesterday, but today she was just more like lightheaded; Low grade fever; feeling sick/doesn't feel good; head hurts really bad/terrible headache; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EH9899, expiration date Mar2021) via an unspecified route of administration on 09Jan2021 at a 0.3mL via injection into the left arm for covid-19 immunization. The patient stated that she had Type 2 diabetes which diagnosed about 10 years ago and high blood pressure diagnosed about 20 years ago, so her providers office sent her a text saying the doctor wanted her to have the vaccine. She confirmed that she had no other vaccines on the same day as the COVID vaccine. The patient stated that she had high cholesterol about 5 years ago and her doctor initially put her on Lipitor, but she got to a point where she could not walk, so her doctor put her on something else, but she could not tolerate that either, so then she was switched to the Pitavastatin Calcium. The patient stated that she also had a very sensitive stomach, but she cannot think of the name of what she was diagnosed with because since she had her a couple of seizures started about two years ago this upcoming Aug, she can't think straight. The patient also had GERD about 5 years ago, macular degenerative disease a couple of months ago. All medical condition was still ongoing. Current concomitant medications included levetiracetam (KEPPRA, Tablet) 500mg, once daily, by mouth started from about two years ago, this upcoming Aug for seizures; metformin 1000mg, two tablets daily, by mouth started from about 10 years ago for Type 2 diabetes; allopurinol Tablet 300mg, once daily, by mouth started from probably 2 or 3 years ago for her kidney; metoprolol tartrate (LOPRESSOR, Tablet) 50mg, once daily, by mouth started from 2 years ago for high blood pressure; empagliflozin (Jardiance, Tablet) 25mg, once daily, by mouth has been on this product about 6 months for Type 2 diabetes; lisinopril Tablet 40mg, once daily, by mouth started from probably about 10 years ago for high blood pressure; diltiazem hydrochloride (CARDIZEM CD, 24 hour Capsule) 180mg, once daily, by mouth started from a couple years ago; omeprazole magnesium (Prilosec, Capsule) 20mg, once daily, by mouth started from probably about 4 years ago for GERD; hydrochlorothiazide Tablet 25mg, once daily, by mouth started probably about 10 years ago for high blood pressure; Vitamin D 125mcg or 5000unit Tablet, once daily, by mouth as Vitamin supplementation started taking this about a year ago. The patient had a blood test where her Vitamin D was a little low. Vitamin C was got it over the counter; PreserVision OTC medication, with Vitamin A, E, C, zinc and copper Two capsules by mouth daily started from about two months ago for macular degenerative disease; pitavastatin calcium Tablet 2mg, once nightly, by mouth for High cholesterol; it was on it before, but started back on it a couple months ago. The patient reported she doesn't feel good and got headache on 11Jan2021, had dizziness and low grade fever on 15Jan2021, had nausea and threw up, sinus pain and heart races a little bit on 17Jan2021. She did not want to go through this again. The patient stated that she had the first shot of the Pfizer COVID Vaccine on 09Jan2021. She felt for a day and a half by Monday, 11Jan2021, she has been sick ever since, she did not feel good at all. She had a terrible headache, and for probably one or two days, she ran a low-grade fever. Her headache was still ongoing, but it had eased up because she was taking Tylenol. The patient stated that the dizziness she had, caused her to be nauseous and she threw up all day yesterday. She tried to eat something today and she was just having bad problems with feeling sick all the time. She asked if there are recommendations for getting the second shot after having symptoms like this. Today is the third day that she had been feeling the dizziness and it had improved a little, like she was not dizzy today like she was yesterday, but today she was just more like lightheaded. The patient reported that the nausea was ongoing, she felt like she was going to get like today like she did yesterday. She did not think she still has a low grade fever, she probably had the low grade fever on 15 and 16Jan2021. She just can't seem to shake not feeling good. At first that it was her sinuses because that was where her head was hurting, but then the sinus pain went away but she still had a headache. The patient stated that her heart also went racing a few times in the night. Yesterday was a bad day, but today she was a little bit lightheaded. She tried to eat some toast today, so she will see if she can keep that down. The outcome of the events headache, dizziness, heart rate increased and sinus pain was recovering and the low grade fever was recovered on 17Jan2021 and other events was not recovered.
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| 71 | 2021-02-01 | nausea | sore arm, nausea. |
| 71 | 2021-02-02 | abdominal discomfort |
about 30 minutes after shot was having extreme fatigued to the point i had to go home and lay down....
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about 30 minutes after shot was having extreme fatigued to the point i had to go home and lay down. Bad head ache, chills, upset stomach, Fever of 100.0, extreme soreness at the shot site. A little bit of a cough and stuffy nose. lasted about 3 days. the headache is still lingering.
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| 71 | 2021-02-02 | decreased appetite |
The next day I woke up with severe muscular pain and joint pain, fever of 100 degrees, dizziness, he...
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The next day I woke up with severe muscular pain and joint pain, fever of 100 degrees, dizziness, headache, appetite loss. Took 2 Tylenol and it improved. 6 hours later I took another 2 Tylenol because the headache came back strong. I sleep a couple of times during the day, and also slept well during the night. The next day felt a little bit better but still in bed, but was able to eat better. The next day went to the Dr. and he prescribed me Meloxicam and 6 hour later Tylenol, after that is getting better.
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| 71 | 2021-02-02 | nausea | Left swollen shoulder and arm much above the elbow, continuing to hand and fingers Headache, nausea |
| 71 | 2021-02-03 | diarrhea |
Shortness of breath requiring 911 call. Also fever, chills/cold feet, new onset diarrhea and cramps,...
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Shortness of breath requiring 911 call. Also fever, chills/cold feet, new onset diarrhea and cramps, severe weakness.
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| 71 | 2021-02-03 | nausea |
Where the injection was given is real sore; Chills; Muscle pain; Joint pain; Fever; Nauseated; shaki...
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Where the injection was given is real sore; Chills; Muscle pain; Joint pain; Fever; Nauseated; shaking really hard; feeling unwell; still cold; Just like when one catches the flu, all the symptoms came at one time; It was so stiff one time; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EK01231), via intramuscular route on the left arm on 19Jan2021 12:11 as a single dose for COVID-19 immunization. Medical history included stomach issues, two stents, pacemaker, asthma that turned into bronchitis. Historical vaccine data included the pneumococcal 13-valent conjugate vaccine (PREVNAR 13) first dose in "September" and the second Pneumonia shot on 11Jan2021, second dose, on the right arm within 4 weeks prior to the COVID vaccine. Concomitant medication included ongoing prasugrel for blood thinner. On 20Jan2021 03:00, the patient experienced really heavy chills, she was shaking really hard, she had muscle pain like the flu, joint pain, fever that started at 100.6 degrees Fahrenheit and worsened to 101.6 degrees Fahrenheit, nauseated, feeling unwell. The caller clarifies that all of the symptoms came on at once, around 3am. Just like when one catches the flu, all the symptoms came at one time. The patient reported that it felt like she had the virus (not specified) all over again. The chills had calmed down, but she was still cold. Where the injection was given it was real sore. She had been doing arm circles and such to keep her muscles loosened up. It was so stiff at one time last night (20Jan2021) that she thought, she could not move it. The clinical outcome of events chills was recovering; muscle pain, fever, nauseated, still cold was not recovered; joint pain, shaking really hard, feeling unwell, vaccination site pain, stiff, flu like symptoms was unknown.
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| 71 | 2021-02-03 | nausea |
Feeling some nausea; Feeling hot; This is a spontaneous report from a contactable pharmacist. A 71-y...
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Feeling some nausea; Feeling hot; This is a spontaneous report from a contactable pharmacist. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284; Expiration date was not reported), intramuscularly on the left arm on 29Dec2020 (12:45) at a single dose for COVID-19 immunization at the hospital. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On 29Dec2020 (13:00), the patient was feeling some nausea; and was feeling hot. The patient had received an unspecified treatment for 'feeling hot'; and had received ondansetron for 'nausea'. The outcome of the events, 'feeling some nausea' and 'feeling hot', was recovered on an unspecified date. The patient was not tested for COVID-19 post-vaccination.
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| 71 | 2021-02-03 | vomiting, nausea |
In the middle of the night about 2AM in the morning I started feeling nauseated and vomited and then...
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In the middle of the night about 2AM in the morning I started feeling nauseated and vomited and then noticed I had chills. Probably after 8AM I took my temp and I had a fever (102F) for about 10 hours. Started aching all over, joint and muscle aches, I also had headache (took Motrin and headache went away), no pain at the injection site. Almost like I had flu symptoms. I felt miserable all day but next day when I woke up I was fine. Went to work as normal the next day. I forgot to state I had COVID in March 2020 and the symptoms I had felt very much like it.
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| 71 | 2021-02-03 | vomiting |
Fever 103.6F with chills; Fever 103.6F with chills; Vomiting; This is a spontaneous report from a co...
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Fever 103.6F with chills; Fever 103.6F with chills; Vomiting; This is a spontaneous report from a contactable other healthcare professional reporting for a patient. A 71-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EH9899, via an unspecified route of administration on 19Jan2021 at 11:15 (at the age of 71 years old) as a single dose in the right arm for COVID-19 vaccination. Medical history included hypertension, seizures, hypothyroid, and attention deficit disorder all from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication names were not reported, but it was reported that she used other medications in two weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination, The vaccine was given at a Nursing Home/Senior Living Facility. On 20Jan2021 at 12:00AM, the patient experienced fever 103.6F with chills, and vomiting. The patient received treatment of Tylenol 1gm once only for fever and chills. The clinical outcome of fever 103.6F with chills, and vomiting was recovered on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 71 | 2021-02-04 | nausea |
Headache, tiredness, muscle pain, chills, joint pain, soreness at injection site and nausea caused ...
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Headache, tiredness, muscle pain, chills, joint pain, soreness at injection site and nausea caused from the really bad headache.
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| 71 | 2021-02-04 | nausea |
cough; injection site pain; headache; muscle pains; joint pain; fever, but not a high fever; nausea;...
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cough; injection site pain; headache; muscle pains; joint pain; fever, but not a high fever; nausea; feeling freezing cold; chills; ache; cold; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246), via an unspecified route of administration at left arm on 19Jan2021 08:15 at a single dose for COVID-19 immunization. She was sick (COVID symptoms) all Dec2020 when she was with her sister who had COVID-19. She does not know for sure that she had COVID 19 because she was never tested. She recovered from that illness about two weeks before getting the Pfizer COVID 19 vaccine first dose. The cough was all gone before she had the Pfizer COVID 19 vaccine. No prior vaccinations (within 4 weeks). There were no concomitant medications. The patient had the vaccine on 19Jan2021, two days ago and had not had a problem. She left there and went to the gym for 1 hour afterwards. Then yesterday morning she woke up and has been sick ever since with a cough and chills. She never tested positive for COVID but she was with her sister who had it during Dec2020. She had a cough similar to the one she had in Dec2020 when she was quarantined for COVID symptoms. She was not expecting anything, but it says you can have side effects if you have had COVID-19 so she was calling in about that. On 20Jan2021 she woke up at 02:00 in the morning with a cough; injection site pain which was not sore before; headache; muscle pains, chills; joint pain; fever, but not a high fever; feeling freezing cold; and nausea. She reported 'cold, chills, fever, ache'. She felt a little bit better today on 21Jan2021. She was scheduled to receive the second dose on 15Feb2021 at 08:15. The patient would like to know whether her history of COVID symptoms from Dec2020 may have aggravated her post-vaccination symptoms. The patient would like to know whether there have been other reports of similar post-vaccination as hers. The outcome of the events cough, injection site pain, headache, fever and feeling freezing cold was recovering; event muscle pain, joint pain and nausea was not recovered; event chills was recovered on 21Jan2021; and unknown for the other events.
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| 71 | 2021-02-04 | stomatitis |
Fatigue swelling of Right Ear internally, painful to the touch Sores in front of mouth, starting on ...
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Fatigue swelling of Right Ear internally, painful to the touch Sores in front of mouth, starting on right side (like a canker sore)
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| 71 | 2021-02-04 | vomiting, abdominal discomfort, nausea | Nausea, vomiting, fever, chills, fatigue, body ache, stomache upset |
| 71 | 2021-02-05 | difficulty swallowing | Throat swelling Difficult to swallow Dry throat |
| 71 | 2021-02-05 | vomiting, appendicitis, abdominal pain |
Acute appendicitis began with abdominal pain, vomiting on 2/3/21, surgery on 2/5/21. Confirmee by C...
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Acute appendicitis began with abdominal pain, vomiting on 2/3/21, surgery on 2/5/21. Confirmee by CT scan and operative procedure.
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| 71 | 2021-02-07 | decreased appetite, nausea, abdominal pain |
The morning following the vaccine, she had a fever, chills, felt really sick. Also had a headache, ...
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The morning following the vaccine, she had a fever, chills, felt really sick. Also had a headache, a lot of muscle and joint pain. She was nauseous, no appetite, and abdominal pain. Very tired as well. She did not take anything for it, just slept and by the morning of 2/6/21 was still tired, but not sick anymore and able to eat some, was not able to prior to this.
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| 71 | 2021-02-07 | nausea, abdominal pain upper |
Stomach hurt/stomach pain; feels like throwing up/Nausea/feels nauseous/sick to her stomach; some pa...
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Stomach hurt/stomach pain; feels like throwing up/Nausea/feels nauseous/sick to her stomach; some pain after inoculation in her arm at the site; dizzy; This is a spontaneous report received from a contactable consumer. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982, expiry date: 31May2021), intramuscular in the left arm, on 21Jan2021 13:00, at 0.3 mL, single, for COVID-19 immunization. Medical history included "kashi disease" which the reporter further explained as a rare disease that affects shape of red blood cells and has to do with spleen; and brittle bones (pending clarification). Concomitant medications included an unspecified infusion which the patient has to go to every other week (also reported as every two weeks) for "kashi disease" and unspecified medications for brittle bones (pending clarification). The patient did not have any other recent vaccinations. On 21Jan2021, the patient had some pain after inoculation in her arm at the site, was a bit dizzy and had stomach issues which started at night. The patient started feeling "stomach hurt"/stomach pain or sick to her stomach on 21Jan2021 at around 23:00 (reported as "11:00PM-12:00PM"), experienced nausea/felt nauseous, stomach pain, and felt like throwing up. The patient still has that in the morning of 22Jan2021. It was reported that they were not treating the stomach pain with anything. The patient's dizziness went away. The reporter wanted to know if the patient would get the same side effects after the second shot. It was also reported that they check the patient's blood once a month doing labs, results were unknown. The outcome of dizziness was resolved on an unspecified date; "stomach hurt/stomach pain" and nausea were not recovered; and vaccination site pain was unknown.
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| 71 | 2021-02-07 | nausea | 2 |
| 71 | 2021-02-08 | nausea |
tiredness, injection site pain, headache, itchey, chills, nausea, feeling unwell, swelling of throat...
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tiredness, injection site pain, headache, itchey, chills, nausea, feeling unwell, swelling of throat, slight rash
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| 71 | 2021-02-08 | nausea |
Weakness/fatigue - onset 1/31/2021. Persisting thru 2/4/ Nausea - 2/4. Mild cough & nasal congestio...
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Weakness/fatigue - onset 1/31/2021. Persisting thru 2/4/ Nausea - 2/4. Mild cough & nasal congestion since 1/31.
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| 71 | 2021-02-08 | vomiting, nausea |
She confirms the rash started after receiving the covid vaccine/terrible rash is up and down both ar...
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She confirms the rash started after receiving the covid vaccine/terrible rash is up and down both arms, the crown of her head, and on her scalp; Pfizer covid vaccine: nausea; Pfizer covid vaccine: chills; Pfizer covid vaccine: hurting at the injection site; Pfizer covid vaccine: headaches/on and off headaches; She cannot speak this morning; Pfizer covid vaccine: vomiting; This is a spontaneous report from a contactable Nurse (patient). A 71-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL8982, expiry date: 31May2021) intramuscular injection in right upper arm on 19Jan2021 10:00 at single dose for COVID-19 immunisation. Her second dose is scheduled on 10Feb2021. Medical history included stage 4 metastatic breast cancer. There were no concomitant medications. The patient previously took Ibrance for stage 4 metastatic breast cancer and experienced broken out in terrible rash. She is taking Ibrance for cancer, she has been taking it for a while. The past few weeks she has broken out in terrible rash. She went to a dermatologist that stated the rash was from Ibrance. She cannot speak this morning (Jan2021). Her doctors are speaking to each other and she is being told not take Ibrance by the dermatologist and to continue taking from her oncologist. Reports she had a pathology report and it showed her skin eruptions she is having is from Ibrance. She clarifies that her terrible rash is up and down both arms, the crown of her head, and on her scalp. She took the first dose of the COVID-19 vaccine a couple of weeks ago. She is having quite a bunch of side effects from the injection. The side effects she is experiencing after the COVID vaccine are nausea, vomiting, chills, hurting at the injection site which is not terrible, and on and off headaches. Events did not require a visit to emergency room or physician office. Nausea started 3 days after the receiving the vaccine on 22Jan2021. Vomiting is still ongoing on and off and started about a week and half after receiving the vaccine (Jan2021). Chills started right away and she still has the chills. It has not changed. The chills started maybe a day after receiving the vaccine (20Jan2021). Hurting at the injection site started the day after (20Jan2021) and lasted for two or three days and is still ongoing, reports it goes on and off. Reports the hurting at the injection site is not terrible. Headaches started a day or so after receiving the vaccine (20Jan2021) and is still ongoing, on and off. Reporter seriousness for events nausea, vomiting, chills, hurting at the injection site, headaches were reported as medically significant. She is currently taking Ibrance since her oncologist told her not to stop taking Ibrance. The dermatologist said her rash is related to Ibrance. When querying causality she reported that she is not sure because she has been taking Ibrance for a while. She confirms the rash started after receiving the COVID vaccine. Events outcome of nausea, vomiting, chills, hurting at the injection site, headaches was not recovered (nausea and vomiting was reported as worsened), while for others was unknown. Relatedness of drug Pfizer COVID vaccine to events for nausea, vomiting, chills, hurting at the injection site, headaches were reported as related.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 71 | 2021-02-10 | abdominal pain upper, diarrhea | Stomach pain , diarrhea and weakness/fatigue |
| 71 | 2021-02-10 | decreased appetite, retching, nausea, diarrhea |
Headache Heart palpitations Nausea Dry Heaving Chills Diarrhea Lack of appetite Sleep interrupti...
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Headache Heart palpitations Nausea Dry Heaving Chills Diarrhea Lack of appetite Sleep interruption
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| 71 | 2021-02-10 | decreased appetite, vomiting, abdominal pain |
Patient had abdominal pain with vomiting last night. Abdominal pain and vomiting now gone but now wi...
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Patient had abdominal pain with vomiting last night. Abdominal pain and vomiting now gone but now with weakness and decreased appetite.
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| 71 | 2021-02-10 | gastrointestinal pain, vomiting, diarrhea |
Feb 10. 8:30 pm started bowel cramping, 10:00 pm to 1:30 am moderate diarrhea with bowel pain. Feb ...
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Feb 10. 8:30 pm started bowel cramping, 10:00 pm to 1:30 am moderate diarrhea with bowel pain. Feb 11 1:30 am moderate vomiting. Felt chills and shaking . No fever.
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| 71 | 2021-02-11 | nausea | DIZZINESS, NAUSEAS, INCREASED IN BLOOD PRESSURE, DECREASE IN BLOOD SUGAR |
| 71 | 2021-02-11 | nausea | nausea, temperature 101 controlled by Tylenol, body aches, chills, fatigue |
| 71 | 2021-02-13 | appendicitis | Appendicitis resulting in laproscopic appendectomy 2/10/2021 |
| 71 | 2021-02-14 | decreased appetite |
weakness, decreased ADL's requiring assistance, incontinence, decreased appetite, decreased fluid in...
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weakness, decreased ADL's requiring assistance, incontinence, decreased appetite, decreased fluid intake, and became bedbound 2 days. On 2/15, resident is improving slowly
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| 71 | 2021-02-14 | diarrhea, vomiting, nausea | Severe headache, nausea, vomiting, diarrhea. |
| 71 | 2021-02-16 | abdominal pain |
Patient states they were fine for 3 days, then on 4th day they started having breathing issues, seve...
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Patient states they were fine for 3 days, then on 4th day they started having breathing issues, severe abdominal pain, unable to get out of bed for 4 days. Made appointment with lung doctor, and sent patient to get covid test, mri of lungs.
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| 71 | 2021-02-18 | abdominal pain | Fever 102.5 with shaking chills and abdominal cramps |
| 71 | 2021-02-18 | nausea, GERD, decreased appetite, vomiting |
Day of Vaccine Tuesday - just tired and right are ached Day after Wednesday started in a.m. nausea ...
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Day of Vaccine Tuesday - just tired and right are ached Day after Wednesday started in a.m. nausea and then vomiting repeatedly throughout the day, body aches and terrible headache, no fever but chilled where teeth were actually chattering, running nose all day, acid reflux, no appetite but even water made me vomit, I became very weak. Slept a lot on and off all afternoon. Next day thursdayI had no symptoms but was weak from all the trauma of the day before. Friday I felt fine
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| 71 | 2021-02-18 | nausea |
I received my first Pfizer vaccination on 12/31/2020 at Vaccination Site. following this vaccine, I ...
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I received my first Pfizer vaccination on 12/31/2020 at Vaccination Site. following this vaccine, I had only a brief episode of chills, nausea and cough for several days. My arm was sore. My second shot 21 days later was a different story. I had it in right arm because my left arm was still aching. ( 01/21/2021 ) date of my second vaccination. Since then I have continually had pain "all over my body" My bones and muscles literally ache so badly I cannot sleep. I have called for appointment with my Dr because it isn't going away. I had a cough ( I never cough) until this past week. My concern is the ongoing aching and soreness in different spots on my skin bones and muscles. My shoulders, neck and pelvic region.
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| 71 | 2021-02-18 | nausea |
Dizziness (severe), cannot sit up or stand up without passing out, convulsing (shaking) and severe n...
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Dizziness (severe), cannot sit up or stand up without passing out, convulsing (shaking) and severe nausea.
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| 71 | 2021-02-18 | nausea | Extremely cold, migraines, nausea, tightness in chest, face rash, joint pains, extremely tired |
| 71 | 2021-02-21 | decreased appetite |
severe muscle and joint pain; severe muscle and joint pain; fever 100°F; dizziness; severe headache...
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severe muscle and joint pain; severe muscle and joint pain; fever 100°F; dizziness; severe headache; no Appetite; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EI9262), via an unspecified route of administration on 24Jan2021 at 14:00 on the left arm at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not have COVID prior to vaccination and had no known allergies. The patient previously received the first dose of BNT162B2 (lot number: EH9899) on 03Jan2021 on the left arm for COVID-19 immunization. It was reported that on 25Jan2021, the next day after the vaccination, the patient woke up with severe muscle and joint pain, fever 100°F, dizziness, severe headache and no appetite. The patient took 2 Tylenol and it got better. Six hours later she took another 2 Tylenol because the headache came back; slept a couple of times a day and had a good night's sleep. Next day, she was a little better but still in bed, she fed myself better. The next day she went to the doctor (prior appointment) and was prescribed Meloxicam and Tylenol 6 hours after and was getting better. The outcome of the events was recovered. Post vaccination, the patient has not been tested for COVID.
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| 71 | 2021-02-21 | nausea | Chills, shivering, nausea, headache |
| 71 | 2021-02-21 | vomiting |
Feb 11, sore arm for one day; Feb 17 started with muscle and joint pain, especially tender right kne...
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Feb 11, sore arm for one day; Feb 17 started with muscle and joint pain, especially tender right knee and overall not feeling well; Feb 18 felt lightheaded and weak with standing through out the day; Feb 19 weakness and lightheaded much worse, had several episodes of vomiting and become too weak to stand; went to ER
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| 71 | 2021-02-22 | difficulty swallowing |
This patient started to feel lightheaded and had a dry mouth approximately 5 minutes after receiving...
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This patient started to feel lightheaded and had a dry mouth approximately 5 minutes after receiving her Pfizer mRNA COVID-19 vaccine. Over the next 20 to 25 minutes she progressed to having a sensation of tongue swelling, then difficulty swallowing, then chest tightness. Her vital signs were stable throughout the observation period (blood pressure 144/74 and 150/70, pulse in the high 80s to low 90s, and oxygen saturation 96-98% on room air) and she was able to speak in full sentences without any respiratory distress. Her lungs were clear and she had no stridor. She never had any pruritic symptoms or rash/hives. Because of the progressive nature of her symptoms, however, I felt she needed emergency room evaluation for observation. We never administered any medication while at the vaccine clinic including epinephrine or Benadryl. After approximately 25 minutes, 911 was called and she was transported by ambulance to the emergency room in stable condition.
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| 71 | 2021-02-22 | nausea, abdominal pain upper |
4"band around both arms with strong pain & pressure, finger joints "lit up " pain, chills, fever, he...
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4"band around both arms with strong pain & pressure, finger joints "lit up " pain, chills, fever, headache, cold feet/hands & back, light headness -feeling might pass out, sneezing, coughing, extreme fatigue,nasal discharge, loss of taste, nausea, stomach ache, knots in throat (very painful) & swelling.
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| 71 | 2021-02-22 | nausea, vomiting |
Patient reports experiencing fever and chills that began about 7-8 hours after receiving the 2nd dos...
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Patient reports experiencing fever and chills that began about 7-8 hours after receiving the 2nd dose. This lasted for about 36 hours. Patient also reports having nausea and vomiting that began about 12 hours after receiving the vaccine. This also lasted for about 36 hours total after receiving the vaccine. Patient also reports increased local pain, redness, erythema 36 hours after receiving the vaccine and states that this lasted for about 96 hours. The skin redness started locally to the injection site and then spread to covering the entire upper arm.
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| 71 | 2021-02-23 | decreased appetite |
Chills with violent shivering starting second night after vaccine and continued for 3 nights. Dren...
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Chills with violent shivering starting second night after vaccine and continued for 3 nights. Drenching night sweats overnight began the 3rd night and is continuing now but lessening slightly in degree. Headaches. Muscles ache and stiffness particularly in legs. Slight loss of balance from time to time. Loss of appetite. Rash on chest possibly caused by sweating at night. Increased severity when bruised.
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| 71 | 2021-02-23 | diarrhea, nausea |
Dry cough; Sore throat; Diarrhea; Nausea; muscle aches; joint aches; extreme fatigue; Headache; have...
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Dry cough; Sore throat; Diarrhea; Nausea; muscle aches; joint aches; extreme fatigue; Headache; have been sick ever since; flu like symptoms; hoarse; This is a spontaneous report received from a contactable consumer (patient). This consumer reported similar events for herself and her husband. This is the first of 2 reports. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3247, expiry date: unknown), via an unspecified route of administration on the right arm, on 20Jan2021 at 10:15-10:30 (as reported), at single dose, for COVID-19 immunization, at the hospital. There were no medical history, family history and concomitant medications. The patient had no vaccinations within four weeks prior to the first administration of BNT162B2 vaccine. The patient reported that she and her husband had the Pfizer Covid 19 shot on 20Jan2021 (last Wednesday). She stated that they have been sick ever since. On 20Jan2021, the patient had flu-like symptoms and at 11:00, she experienced headache. On 21Jan2021, the patient experienced nausea, muscle aches, joint aches and extreme fatigue. On 22Jan2021, the patient had sore throat during the night and diarrhea. On 23Jan2021, the patient had dry cough. On an unspecified date in Jan2021, the patient was hoarse. The events did not require emergency room visit of physician office visit. The patient wanted to know if they should get the second shot. The outcome of the events "have been sick ever since", "flu like symptoms", headache, nausea, extreme fatigue and "hoarse" was not recovered; the patient was recovering from muscle aches and joint aches; the patient recovered with sequel from dry cough on 23Jan2021 and sore throat on 24Jan2021; the patient recovered from diarrhea on 24Jan2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021093716 Same reporter, suspect drug and events; different patients
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| 71 | 2021-02-23 | diarrhea |
Initially on Friday onset of diarrhea, followed by fever to 101 if I remember correctly maybe slight...
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Initially on Friday onset of diarrhea, followed by fever to 101 if I remember correctly maybe slightly above that, cough, debilitating fatique and bone aches and chills and headaches lasting until almost 5 January. Second shot administered 01-18/2021 Pfizer Lot #EL3249 - again, significant fever, terrible chills and bone aches lasting approx 4-5 days.
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| 71 | 2021-02-23 | nausea | Very severe chills, flushing, hives, nausea |
| 71 | 2021-02-24 | nausea, vomiting, diarrhea |
Woke up extremely hot, nauseaus. At 0410 I felt like I had to have a bowel movement, sat on toilet f...
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Woke up extremely hot, nauseaus. At 0410 I felt like I had to have a bowel movement, sat on toilet for awhile, projectile diarrhea began. Then vomiting. Same symptoms I had with Covid in June. extremely tired for about a week. Called my son who works for Pfizer the next day (the 4th of February). I want to reschedule my second vaccine for later in March because my Endocrinologist has put in a referral to have my antibodies tested. Unfortunately I just had a tooth extracted and am on antibiotics, not sure if that will affect the antibody test or the second vaccine.
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| 71 | 2021-02-25 | diarrhea, nausea |
Nauseated; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 71-year-o...
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Nauseated; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received bnt162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration in left arm on 20Jan2021 01:30 at single dose for covid-19 immunization. Medical history included heart problem, she is a pump diabetic user/diabetes, mini stroke, Heart attack. The Family Medical History included heart problems and diabetes. There were no concomitant medications. Patient took the Pfizer COVID vaccine. She was reading the side effects and was wondering if she would have side effects this long after having the shot. She woke up today (26Jan2021) feeling nauseated and started diarrhea this morning. This is day 6 after the shot. No treatment. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 71 | 2021-02-25 | flatulence, abdominal pain upper, nausea, indigestion |
My arm hurt; I started to get little tired; I couldn't watch TV; My stomach suddenly did not feel we...
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My arm hurt; I started to get little tired; I couldn't watch TV; My stomach suddenly did not feel well; Nauseous; I got cold; Sick; was very hot and so hot; was round up/she was feeling she would faint; waves of feeling like i would pass out; it was just being very hot, then being cold; Blood drained from my head, I just knew I was going to pass out; I took 0.2 rather than the 0.3ml of the first dose; very fast heart rate intermediately for many day; squeezing of chest; muscle hurting/Pain in my body in every muscles, my fingers, my hands, my calves, my feet, my back, neck, everything; digestive disorders; feeling gassy, uneasy; stomach abdomen was just tight; abdominal issue; feeling gassy, uneasy; stomach abdomen was just tight; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: E18982), on 21Jan2021 (at the age of 71-year-old) at single dose for COVID-19 immunisation. The patient reported that based on her history of reactions to medications, the nurses giving injections "decided 0.2ml instead of 0.3ml", which is what they gave, so she got 0.2 that is two-third of the shot. The 2nd shot was for 8'oclock on 11Feb2021. She is very sensitive to shots, vaccines, and to all medications and injections and things like that. She has sensitives thanks to two concussions she had in her life. She never was before that she had two concussions. Second one had a crazy man hit her after that just noticed that just have reactions not adverse or dying but definitely take rest of everything. So she take less of a shot, like a dental shot or cortisone shot, which she had taken in the past. If she has dental shot she cannot take Novocain, had to take Carbocaine or Marcaine and they give her half. Also she had been taking cortisone shot for shoulder for rotator cuff injury. They also have to give her less. Or flu shot: she takes half one week and come back for the other half the next week. Just have reactions. She told to when arrive for medication and did have one anaphylactic reaction but that was to cat skin dye, was told to this two nurses who was administering the vaccine and said to them she was really afraid to take. It is just too much for her. She knows her body. She is sure have reaction but is really afraid and don't know what is the first one will do to her. They just did two nurses and she decided that she will be taking 0.2 instead of 0.3ml which is what they gave. She got 0.2 so that two third of the shot and waited the half an hour, a nurse watched her card and 7 other cards. She did not have the anaphylactic reaction. She went home. Her arm hurt and started to get little tired. The events started the day that she got the shot. Like about 3 or 4 hours later. It is just few hours later she couldn't watch TV so went to laid down and an hour later she woke-up. She walked to her kitchen and blood drained from her head, she just knew she was going to pass out. Her stomach suddenly did not feel well. She tried to get back her bed but she was round up and as far as the bathroom. She got very nauseous, she laid down on bathroom floor. She thought she was sick but didn't round up having to use toilet of few times. Although while she was feeling she would faint. She was very hot and so hot. While lie down, she couldn't even pulling off her pajamas. So when she got cold so she was pulling a towel down and stop and she laid to for two hours, she finally got to her bed. It was a terrible experience. Next day she drank water and had potatoes prepared and went up eating back to later baked potatoes. Next day luckily she did not have repeat of the nausea. She didn't have that anymore of. She did have abdominal issue just not diarrhea or anything but just not feeling well, feeling gassy, so uneasy. This all lasted, that part lasted for 7 days. What concerned her was especially beside first day it was few days she got off again. She was just feel blood drain but not this first time she laid on floor. She couldn't sit on chair to watch TV for about 3 days. She mostly laid on bed but she would get very hot and then very cold during the day. She would get very fast heart beat not continue but really fast like heart was pounding her chest. She felt like someone has their hand inside her body squeezing her chest. She got afraid but didn't want to go hospital. She didn't think she was sick enough. She was concerned. So that was happened and this last was for about 7 days. Then the squeezing of chest part went away. She doesn't want to wind-up on the floor feeling that sick again, she felt so sick it felt like food poisoning. After that, it was just being very hot, then being cold, the fast heart rate, every muscle hurting. Those were the main things that continued for a week. And digestive disorders. It all lasted for about 13 days. She was concerned she had a very fast heart rate intermediately for many days, for about a week. And that's considered an adverse reaction and also she was getting waves of feeling like she would pass out, everything would drain from her head. She experienced stomach ache, feeling hot then cold. She wants to do precautions before taking the second dose on 11Feb2021. She did take may be 3 days later two Tylenol but didn't take anything (clarification requested). She didn't even take vitamins during that time. She was afraid to take anything so she did not. At the same time also there was pain in her body in every muscles, fingers, hands, calves, feet, back, neck, everything. Her stomach abdomen was just tight. She was concerned that last for few days. In last few days she started feel herself and now she is going again tomorrow. So that how she reacted. She doesn't know how much of this shot she told them she could tolerate because everybody is saying second shot will give you more reactions. All she can take this more than that because that was lot. She wants to be herself, don't want laying on floor, don't want to have 105 temperature or anything. The patient was asking if she should take another 0.2ml another two-third of the shot. She just asked them for half that is 0.15 would that be a big difference. She needed to know by 8 o'clock tomorrow. I might be in a queue to get it. She stated: 'So, that's my concern. I'm all alone, I'm a senior, I have no family. I lost my mother to covid. I know I need this vaccine, but I just, I cant get that sick and I'm so afraid I'll wind up with a 105 something, fainting away and no one knowing'. She was asking if reactions after the 2nd dose are worse than the 1st dose, if she didn't have anaphylaxis after 1st one, she shouldn't have it a 2nd time, right. She said, "1st half of flu shot, I get sick, then the 2nd half nothing". She also asked if she can take medications after the vaccine, like Tylenol, or irritable bowel syndrome (IBS) medication she takes as needed. The events resolved, but the patient reported it took her like 13 days before she felt better.
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| 71 | 2021-02-25 | nausea, decreased appetite |
Within 24 hrs, experienced severe dizziness, resulting in 2 falls while attempting to stand up. Al...
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Within 24 hrs, experienced severe dizziness, resulting in 2 falls while attempting to stand up. Also had headache, loss of appetite, and nausea, but the alarming side effect was the dizziness. Dizziness also subsided after less than 12 hrs.
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| 71 | 2021-02-25 | nausea | Shortly after receiving the vaccine the patient complained of a headache and nausea |
| 71 | 2021-02-25 | vomiting | Severe vomiting, chills, fatigue, body aches and shakes lasting 7 days |
| 71 | 2021-02-26 | decreased appetite |
Left and right arms sore and achy for 3 days; felt tired and ill the night of the shot and all the n...
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Left and right arms sore and achy for 3 days; felt tired and ill the night of the shot and all the next day; general malaise feeling; loss of appetite; headache; slight swelling of sinuses and rash on face. Took Benadryl the first and second nights, used hydrocortisone cream on rash, took Tylenol. End of day three feeling better, almost normal.
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| 71 | 2021-02-26 | nausea |
pt complained of nausea and dizziness 5 minutes post injection. Pt with elevated blood pressure 188...
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pt complained of nausea and dizziness 5 minutes post injection. Pt with elevated blood pressure 188/88 decreased mentation
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| 71 | 2021-02-26 | nausea |
I received the first Pfizer vaccine t 2:45 PM on Thursday, 2/25/21. That night when I went to bed I ...
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I received the first Pfizer vaccine t 2:45 PM on Thursday, 2/25/21. That night when I went to bed I felt chilled and woke up several times feeling chilled. In the morning I felt sick with similar symptoms as when I had COVID-19 in March2020. I had head pains, inner ear pains, naseau, sore muscles, and extreme fatigue. I slept the whole day, waking up and going back to sleep. I dranka little, but just didn't feel like it. I ate a piece of toast with butter that evening and then felt naseauated. I slept through the night and woke up feeling a little better the next day, but still feel tired and have some pains in my head.
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| 71 | 2021-02-27 | nausea | extreme nausea for 24 hrs., low grade fever for 48 hrs. |
| 71 | 2021-02-28 | abdominal pain |
Severe abdominal pain. Started as diffuse cramps, surged to the most severe pain I have ever experie...
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Severe abdominal pain. Started as diffuse cramps, surged to the most severe pain I have ever experienced. The pain extended below my left rib through the area above my hip to my navel and then to my entire abdominal area. As noted, it ranged from severe cramps (maybe only a 4 on a NPRS) to searing pain that I would mark as a 10 on a NPRS. This subsided and then surged about 5 times in the space of 30 minutes. At one point, I got very hot, but I didn't have a fever. The pain was so bad and I felt so horribly sick that I was about to ask my husband to take me to the ER. I had a Cesarean section in 1978 followed by two natural, unmedicated VBAC births in 1981 and 1985, and, although I know we "can't remember pain," the pain I experienced last night was far, far worse than the pain of childbirth. After it went away, everything immediately went back to normal, as if it hadn't happened.
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| 71 | 2021-02-28 | diarrhea |
Within first 30hrs of receiving vaccine: chills (twice), body aches, diarrhea (twice); fatigue, fev...
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Within first 30hrs of receiving vaccine: chills (twice), body aches, diarrhea (twice); fatigue, fever (did not exceed 100 degrees). Underarm pain, enlarged lymph node began within 2 days post 2nd vaccine. ( Friday-Sat. Feb. 26-27) Within four days (Sunday Feb. 28) redness, swelling, pain and itching began in upper arm. ....neck pain reduced. By Monday, March 1, I contacted my family practice clinic and received a video consult with Dr.
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| 71 | 2021-02-28 | diarrhea |
Extreme Diarrhea for 5 days ( soiled pj?s, underwear, and clothes because it came on so fast and was...
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Extreme Diarrhea for 5 days ( soiled pj?s, underwear, and clothes because it came on so fast and was so painful that I couldn?t run to the bathroom quickly enough) Fever and chills for 5 days ( would wake up 1-2 times each night drenched in sweat) Severe headache for 4 days
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| 71 | 2021-02-28 | nausea, abdominal discomfort |
I got a big side effect dizzy and I was almost falling; dizziness; Headache; Nauseous; Feel pinch in...
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I got a big side effect dizzy and I was almost falling; dizziness; Headache; Nauseous; Feel pinch in my stomach; Lot of pain in my whole body; Chills especially at night; Tinnitus; I can't hear you very well because it's so bad. I have a lot of noise in my ear and I can't listen you very well. I couldn't hear; Little side effect of the vaccine, but it continued till now and I feel so sick now; scared because she was falling; scared because she was falling; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot#: unknown), via an unspecified route of administration on 21Jan2021 (also reported as on Wednesday) at SINGLE DOSE for COVID-19 immunization. Medical history included blood pressure high and diabetes. Concomitant medication included glimepiride (GLIMEPIRIDE) for diabetes and olmesartan (OLMESARTAN) for blood pressure high. It was reported that the patient was experiencing for over a week a lot of side effect of the vaccines. She was scared because she got dizzy which she was almost falling (also reported as scared because she was falling) in Jan2021. The patient also had headaches (a lot of headaches) and every day she had to take pills. She also felt like nauseous and pinch in her stomach. She had a lot of pain in her whole body and have chills especially at night after she had the COVID-19 Vaccine. The patient also had got a lot of tinnitus (lot of noise in her ear and can't listen very well) she can't hear very well because it's so bad. She also felt so sick now that she doesn't feel like doing nothing just to be in bed. The patient events were not recovered (continued till now). Information on the Lot/Batch number has been requested.
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| 71 | 2021-02-28 | nausea |
headache; nauseous; soreness at the site; extreme fatigue; This is a spontaneous report from a conta...
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headache; nauseous; soreness at the site; extreme fatigue; This is a spontaneous report from a contactable consumer (patient herself). A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN5318, expiration date was unknown), via an unspecified route of administration in the left arm on 24Jan2021 at 12:15 at a single dose for COVID-19 immunization. The vaccine facility type was reported as "other." Relevant medical history included hyperactive thyroid; known allergies to penicillin, eggs, and cashews; and severe allergy to all dairy products; all from an unknown date and unknown if ongoing. Concomitant medications included fluvastatin, ezetimibe (ZETIA), acetylsalicylic acid (BABY ASPIRIN), and unspecified multivitamins. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. She had not tested for COVID post vaccination. On 24Jan2021, after 2-3 hours of receiving the vaccine, the patient became very nauseous, which lasted for three days. It had eased at the time of the report. On 24Jan2021, the patient also had soreness at the site, extreme fatigue, and headache. The patient had headache for about one day; however, she managed to deal with it without pain killer. The patient drank a lot of warm water with fresh ginger and lemon (with peel) to control the nausea. The patient was very fatigued for three days following the vaccine. Therapeutic measures were taken as a result of nauseous. The patient did not receive treatment for the events "soreness at the site, extreme fatigue, and headache." The patient was recovering from the events "nauseous, soreness at the site, extreme fatigue, and headache."
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| 71 | 2021-03-01 | nausea |
Patient was feeling slightly dizzy after receiving her vaccine. Patient said that her vision was haz...
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Patient was feeling slightly dizzy after receiving her vaccine. Patient said that her vision was hazy and she was feeling slightly nauseous. Patient said that she had a history of stomach problems and indigestion. Her blood pressure was 160/101 but she did not know what it normally ran. Patient felt better after sitting for while and her vision returned to normal.
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| 71 | 2021-03-02 | abdominal discomfort | Headache, upset stomach, light headed |
| 71 | 2021-03-02 | difficulty swallowing |
Patient is allergic to shellfish. Throat and eyelid swelling occurred 1 hr post vaccination. Also ha...
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Patient is allergic to shellfish. Throat and eyelid swelling occurred 1 hr post vaccination. Also had difficulty swallowing. Patient took Benadryl but did not feel better so went to the ED. Was observed for 3 hours and symptoms improved. Received more Benadryl in the ED as well as Solumedrol and Xopenex.
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| 71 | 2021-03-02 | nausea |
Headache, cold, hot, nausea, swelling at vaccination site, red and itchy at vaccination site too, fa...
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Headache, cold, hot, nausea, swelling at vaccination site, red and itchy at vaccination site too, fatigue Was sick for 17 days. Dr. prescribed steroids and nausea medication.
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| 71 | 2021-03-02 | nausea | Freezing , headache , nauseous, fever , dizzy |
| 71 | 2021-03-02 | nausea |
Nauseous; Weak; Really unwell; Tired; Muscle aches; Headache; This is a spontaneous report from a co...
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Nauseous; Weak; Really unwell; Tired; Muscle aches; Headache; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: CN5318, via an unspecified route of administration at right arm on 29Jan2021 09:00 at a single dose for COVID-19 immunisation. Medical history was not reported. Historical vaccine included first dose of BNT162B2 on an unspecified date. There were no concomitant medications. On 29Jan2021, at 7 pm, the patient was nauseous and weak. At 9 pm, the patient was really unwell, tired, headache, muscle aches and nausea. She slept all Friday night, all day Saturday. Late around Sunday was finally able to get out of bed. Asked if she should see a doctor. The patient was still nauseous and weak. The outcome of the events nausea and weak was not recovered. The outcome of other events was unknown.
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| 71 | 2021-03-02 | nausea | Chills, body aches, headaches, slight nausea, sore arm |
| 71 | 2021-03-03 | nausea | Very bad headache that started around 2 am on 3/2, lasting about 6 hours, with nausea and chills |
| 71 | 2021-03-03 | nausea |
Fever; nausea; headache; achy. Fever lasted several hours starting around 11:00 pm. Nausea lasted 36...
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Fever; nausea; headache; achy. Fever lasted several hours starting around 11:00 pm. Nausea lasted 36 hours (about), aches and pain lasted about 48 hours. Tylenol for fever.
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| 71 | 2021-03-04 | nausea, vomiting |
Patient was experience nausea, dizziness, vomiting, weakness, headache, and chills. It started aroun...
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Patient was experience nausea, dizziness, vomiting, weakness, headache, and chills. It started around 7am on March 3rd, when she woke up. The symptoms lasted almost all day, and he started to feel better around 6:30pm on the same day, March 3rd. He was able to eat and drink at this time without feeling nauseous. On March 4th, he experienced mild headache and was feeling a little dizzy, but much better. She is able to eat and drink, and move around the house now.
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| 71 | 2021-03-04 | retching |
I WOKE UP AT 3;30 AM ON WED 3/3/2021 WITH EXTREME DIZZINESS, GAGGING WITH THICK FLUID-SPITING IT OU...
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I WOKE UP AT 3;30 AM ON WED 3/3/2021 WITH EXTREME DIZZINESS, GAGGING WITH THICK FLUID-SPITING IT OUT TO THE TRASH I CAN'T GET MY BALANCE GETTING OUT OF BED BLOOD PRESSURE TO 163/92 PULSE OF 106- 3Kl lei & STILL EXPERIENCING LIGHT HEADEDNESS & WABBLE WALKING
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| 71 | 2021-03-05 | decreased appetite | Extreme fatigue, 101.7 temperature, no appetite, lasted from 8 am to 7 pm |
| 71 | 2021-03-05 | nausea | achiness, low grade temperature, nausea, started on day of shot and continued for two more days |
| 71 | 2021-03-05 | nausea |
14 hrs after dose I had intense chills. 2 hrs later woke up drenched in sweat. Bad headache for 24...
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14 hrs after dose I had intense chills. 2 hrs later woke up drenched in sweat. Bad headache for 24 hours, nausea for 24 hours. Very tired, could not get out of bed the next day, slept almost 36 hours.
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| 71 | 2021-03-06 | decreased appetite, nausea, diarrhea, abdominal pain |
Site pain, swelling, chills, body aches 6hrs and by next day. 4 days later- bellyache, cramps, burn...
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Site pain, swelling, chills, body aches 6hrs and by next day. 4 days later- bellyache, cramps, burning diarrhea, nausea, lack of appetite, more fatigue. Last symptoms hard to shake. Better and then back.
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| 71 | 2021-03-07 | decreased appetite, nausea | Fever, chills, fatigue, nauseated, dizziness, loss of balance, thristy, no appetite. 2 1/2 days |
| 71 | 2021-03-07 | decreased appetite |
Low grade fever, chills, flu-type aching, loss of appetite, extreme fatigue, pain at injection site,...
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Low grade fever, chills, flu-type aching, loss of appetite, extreme fatigue, pain at injection site, joint and muscle pain. The worst of it was the Wednesday after late Monday afternoon vaccination; ie on day two post-vax. Felt like a case of bad flu. Lasted about 2 to 3 days, with tapering severity. A week later, energy level is still down; sleeping more than usual.
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| 71 | 2021-03-08 | diarrhea | Fever and Chills body aches joint pain Runny nose diarhea |
| 71 | 2021-03-08 | nausea |
With my first vaccine shot on 2/1/21 I developed a small itchy spot on my neck immediately following...
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With my first vaccine shot on 2/1/21 I developed a small itchy spot on my neck immediately following injection. The doctor on site recommended waiting there at the hospital to monitor it for a few minutes, and I did, and the spot went away. My second vaccination was 2/24/21 and the next day, around noon, I started to have a back ache. Late afternoon I became a little light headed and slightly queasy. That night the pain started in my joints - neck, shoulders, all down my back. They became rather intense, and at one point during the night, after I had managed to fall asleep, I was awoken with burning pain in both elbows, and random sharp pains in toes and fingers. I took Tylenol through the afternoon and night. The following day I was still sore, but not in pain. Then all symptoms disappeared. Not severe enough to seek medical attention but thought I ought to report symptoms for medical research reasons.
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| 71 | 2021-03-08 | nausea | Extreme dizziness and nausea on 3/6/21, is getting progressively better little by little. |
| 71 | 2021-03-08 | nausea |
fever of 101.9 for 2 full days- lessened on 3rd day-, headache, nausea, chills, muscle aches includ...
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fever of 101.9 for 2 full days- lessened on 3rd day-, headache, nausea, chills, muscle aches including my fingers, runny nose, sore skin to the touch on left lower arm. Sore skin did not occur until 4th day. very fatigued throughout. All symptoms gone by end of 4th day.
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| 71 | 2021-03-08 | nausea |
felt nauseated and sweaty. resolved with observation and orange juice. no resp symptoms, no rash, no...
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felt nauseated and sweaty. resolved with observation and orange juice. no resp symptoms, no rash, no hives
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| 71 | 2021-03-08 | vomiting | Woke up vomiting. Continued until mid morning. Called ambulanced and went to ER |
| 71 | 2021-03-08 | vomiting | headache, severe Vertigo, vomiting, chills. bouts of dizziness has continued. |
| 71 | 2021-03-09 | nausea |
About 6 hours after the vaccine she felt really, really sleepy. Then she laid down and then her lef...
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About 6 hours after the vaccine she felt really, really sleepy. Then she laid down and then her left hand started stinging all over. Both legs started getting a strange warm sensation, the size of a pea that kept getting warmer. She was not able to get up or open her eyes, doesn't know if she passed out but apparently went to sleep and slept for 3 hours and woke up and went to bed. She then had toe cramps on her left foot, then got up and walked around the bed and laid down again and fell asleep until the morning. She did not feel normal until 3/5/21. On Sunday, 3/7/21 had nausea, took something for that and the next day she was fine.
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| 71 | 2021-03-10 | decreased appetite | chills, fever, body aches, headache, loss of appetite and no energy/tired |
| 71 | 2021-03-10 | nausea | Headache, fatigue,fever, muscle ache at injection site, naysea |
| 71 | 2021-03-10 | nausea |
20 minutes after injection, I began feeling progressively warmer as if I had beads of sweat on my fo...
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20 minutes after injection, I began feeling progressively warmer as if I had beads of sweat on my forehead. I began to feel light as if my body was light. The Lead Monitor came over and had my blood pressure and oxygen levels checked over the next 40 minutes before I felt actually fine and able to walk out. At no point did I have trouble breathing although that question was repeatedly put to me. Then at home I took it easy but noted anything out of the ordinary. 1.5 hrs after the injection and lasting only 2 minutes, I felt like a band was being tightened around my head to the point of discomfort but not pain. 24 hrs after the injection, for less than one minute, my left temple felt pressure as if I had a head cold. I haven't had a headache in a decade so this was unusual for me. 10 hrs after the injection, I was awakened to by cramping from lower Achilles to foot in my right leg only. This lasted painfully for 12 minutes. My right foot itself felt numb. I would stand to stretch the muscle/ tendon but then immediately felt nauseous. I hate feeling nauseous so I would lay back down only to have to stand again due to the pain of the persistent cramping. This was 12 minutes of excruciating leg cramps. When usually I might have only one or two very brief leg cramps per year. 14.5 hours after injection, I awoke very thirsty adn my skin felt very dry. I drank water and applied hand lotion. Thereafter the vaccine site felt sore but the injection site would have been invisible but for the bandaid outline that narrowed down where the injection had to have been located. The vaccine site was never red or pink or raised at all. Just a pin prick if you really looked for it. As a follow-up, the second Pfizer dose was Lot EM9809 on Feb. 26, 2021, and I had no reaction at all. No visible injection site in right arm, no warmness, no light-headedness, no cramps, nothing at all happened.
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| 71 | 2021-03-11 | decreased appetite, vomiting, nausea, diarrhea |
12/10, 5:00 p.m. Loss of appetite, nausea (continued for next 18 hours), very sore right arm; 12/...
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12/10, 5:00 p.m. Loss of appetite, nausea (continued for next 18 hours), very sore right arm; 12/11, 3:00 a.m. Chills, all over body ache, headache, extreme fatigue, very sore arm; (continued for next 12 hours); 12/11, 12 noon, diarrhea, vomiting (one episode each); 12/12, 6 a.m. - 3 p.m. mild body ache, mild fatigue, mildly sore arm
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| 71 | 2021-03-11 | diarrhea, nausea |
Afib episode; rapid heart beat; pain in jaw; diarrhea; headache; nausea; dizziness; This is a sponta...
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Afib episode; rapid heart beat; pain in jaw; diarrhea; headache; nausea; dizziness; This is a spontaneous report from a contactable consumer (patient). This 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number El266) via an unspecified route of administration in the left arm on 05Mar2021 at 09:00 (at the age of 71-year-old) at single dose for COVID-19 immunisation. Relevant medical history included atrial fibrillation, asthma, chronic obstructive pulmonary disease, high cholesterol, acid reflux disease, depression and anxiety. Concomitant medications included clonazepam, apixaban (ELIQUIS), fluoxetine, metoprolol and simvastatin. On 07Mar2021 at 14:00, the patient experienced Afib episode, rapid heart beat, pain in jaw, diarrhea, headache, nausea and dizziness; the events Afib episode and rapid heart beat were considered serious as life-threatening. The patient received corrective treatment for the reported events, which included 2 tablets of metoprolol. The patient did not have COVID-19 prior to vaccination, and she was not tested for COVID-19 post vaccination. The patient recovered from the events on an unspecified date. No follow-up attempts are possible. No further information is expected.
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| 71 | 2021-03-11 | nausea | Joint pain over entire body, chills, nausea, bad headaches, site redness and tenderness,. |
| 71 | 2021-03-11 | nausea |
led to a fall (possible faint) that caused a head injury (bone chip above her eye).; led to a fall (...
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led to a fall (possible faint) that caused a head injury (bone chip above her eye).; led to a fall (possible faint) that caused a head injury (bone chip above her eye); led to a fall (possible faint) that caused a head injury (bone chip above her eye); led to a fall (possible faint) that caused a head injury (bone chip above her eye); Nausea; shivers; fever; dehydration; This is a spontaneous report from a non-contactable consumer (patient) 71-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), (batch/lot number and expiry date not reported) via an unspecified route of administration, on 22Feb2021 (in the age of 71-years-old) at single dose for covid-19 immunization. Medical history included chronic headaches, high cholesterol, high blood pressure and minor heart condition. Patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medications included candesartan, rosuvastatin, gabapentin, topiramate, amitriptyline and erenumab aooe (AIMOVIG), all from an unspecified date for an unspecified indication. It was reported that 2 days after second dose (reported as 24Feb2021), the patient experienced nausea, shivers, fever and dehydration which led to a fall (possible faint) that caused a head injury (bone chip above her eye). As a result, the patient had an ER visit and they provided her with fluids and stitches. The outcome of events was reported as 'recovering'. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 71 | 2021-03-12 | diarrhea, nausea |
woke at1 am with pain, that made sleep impossible, diarrheas', nausea, chills , fever; still experi...
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woke at1 am with pain, that made sleep impossible, diarrheas', nausea, chills , fever; still experiencing at 2"15 pm
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| 71 | 2021-03-13 | decreased appetite | Chills, shaking, dizziness, fatigue, loss of appetite |
| 71 | 2021-03-13 | nausea |
Developed slight headache about an hour after shot. Then 7:00 PM was hit with bad case of nausea. ...
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Developed slight headache about an hour after shot. Then 7:00 PM was hit with bad case of nausea. Had nausea meds and took one which calmed things down. Then at 3:00 AM on 3/13 2021 was hit with nausea again.. Took more meds for nausea and have been fine ever since. Developed overall Muscle Aches (not joint aches!) all day Saturday 3/13/2021. Still have some muscle aches today 3/14/2021. Left arm became sore on Saturday 3/13/2021 and whole left shoulder is sore today (3/14). Otherwise feel great!
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| 71 | 2021-03-13 | vomiting, nausea |
intense headache, muscle pain, chest pain, chills, nausea, vomiting, lightheadedness, lethargy I to...
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intense headache, muscle pain, chest pain, chills, nausea, vomiting, lightheadedness, lethargy I took Tylenol Extra Strength tablets for the headache & muscle pain. The headaches lasted for 3 days. The muscle pain for 3 days. The vomiting occurred on the day after the shot - 1 time. I remained nauseous for the next 3 days. The chest pain has been on and off for the past 2 days. It has been mild. The lightheadedness lasted for 4 days. The lack of energy is still ongoing, but is getting better.
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| 71 | 2021-03-14 | abdominal pain upper, diarrhea |
moderate anaphylaxis - body shaking, rapid heart beat, high and fluctuating blood pressure, immedia...
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moderate anaphylaxis - body shaking, rapid heart beat, high and fluctuating blood pressure, immediate dry throat and feeling of dehydration, stomach cramps followed by diarrhea about half hour after onset. Symptoms eased after 30-40 minutes so that I could get home and then diarrhea and weakness and shakiness for 3-4 hours. No epi pen administered because breathing was ok
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| 71 | 2021-03-14 | abdominal pain upper |
Sore Arm for 6 days, migraine the next day only in the morning, chills not fever off and on, stomach...
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Sore Arm for 6 days, migraine the next day only in the morning, chills not fever off and on, stomach ache,
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| 71 | 2021-03-14 | nausea, diarrhea, abdominal pain upper |
Did not begin symptoms until 10 days after injection. Began with body aches on 10th day. On 11th d...
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Did not begin symptoms until 10 days after injection. Began with body aches on 10th day. On 11th day most severe: Extreme chills, all over body aches, fever, stomach pain, fatigue, nausea, severe headache. Days 12 - 14: Body aches, fever, stomach pain, fatigue, nausea, headache, sweats. Day 15 and day 16: (today) Tired, mild headache, fatigue, diarrhea.
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| 71 | 2021-03-17 | nausea | Nausea weakness |
| 71 | 2021-03-18 | vomiting |
Chills; weak; couldn't get warm; fatigue; vomited; tired and lethargic; muscle pain; Low back pain; ...
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Chills; weak; couldn't get warm; fatigue; vomited; tired and lethargic; muscle pain; Low back pain; This is a spontaneous report from a contactable consumer (patient). This 71-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unspecified if 'EL9264' or '3L9264'), via an unspecified route of administration, on 09Feb2021 01:30PM at a single dose on the right arm for COVID-19 immunization. Medical history included thyroid disease (was diagnosed in her 40s, 30 years ago) from 1991, blood pressure high (was diagnosed in her 40s, 30 years ago) from 1991, mitral valve prolapse from 2001 (was diagnosed about 20 years ago), little heart disease (which she was told was nothing to worry about), her heart running away from her (They did extensive heart tests and pictures, all that stuff, put her on a medicine called Atenolol which makes her heart beat regularly and not have spells while she is walking of her heart running away), and double knee surgery three years ago (2018) when they put in false knees. Concomitant medications included levothyroxine sodium (SYNTHROID) for thyroid disease, atenolol (ATENOLOL) from 1991 for 'her heart running away from her' (She has been on atenolol 30 years, since she was 40 something. It is good medicine, and she doesn't have her heart running away.), tramadol (TRAMADOL) for double knee surgery three years ago (2018) when they put in false knees, and she also takes two high blood pressure medications. The patient added that all of the medications she takes she has been on about 30 years. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), on 18Jan2021 01:30PM on the right arm for COVID-19 immunization. The patient reported that she had received both doses of the Pfizer COVID-19 vaccine. She has been told that the AEs (adverse events) associated with the vaccine would happen within 12 hours. However, her AEs had been occurring in stages. On 10Feb2021, she had muscle pain. On 11Feb2021, she woke up and threw up and was in bed all day having fatigue. At the date of report, 12Feb2021, she was still on her bed, tired, and having chills. She wanted to know if it is normal to have these reactions 3 days after the shot. She further reported that she got the second dose. And after feeling wonderful after the first dose, she got the second dose on 09Feb2021 and later that night her lower back was killing her. She later clarified that she had low back pain. She stated that she knows that part of side effects that she read for when someone got the shot was that they can have a headache and she was told side effects should only last 12 hours. She stated that on the 11Feb2021, she woke up that morning and couldn't make it out of bed and vomited, then had to get up and clean her bed and put on new sheets. She only vomited once. She stated she has been so tired and lethargic that she stayed in bed all day on the 11Feb2021. At the time of report, on February 12Feb2021, she was having chills, she couldn't get warm, and she didn't have a fever, but she is still weak. Since she was told side effects would go away within 12 hours and this has been three days, she asked if what she was experiencing was normal. As for corrective treatment the patient reported that she also takes tramadol since she had double knee surgery three years ago (2018) when they put in false knees; that's when she started taking Tramadol for that. She said she also took it for the back pain which it kept it at bay until it wore off. Her lower back pain is already gone at the time of report; she was just having chills still and was tired. She stated she has had so many symptoms on different days that she was just questioning. She stated that everyone else who was sick with the second dose it lasted 12 hours, and her friends who really got sick with it, hers is minor, but she would like to know if it is normal that it is still lasting. Outcome of the event low back pain was recovered on an unspecified date in Feb2021. Outcome of the events weak, couldn't get warm, chills and tired was not recovered. Outcome of the other events was unknown. Information on batch number has been requested.
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| 71 | 2021-03-20 | decreased appetite |
Moderate pain at injection site in right arm. Pain also began in non-injection left arm (site of the...
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Moderate pain at injection site in right arm. Pain also began in non-injection left arm (site of the first injection) about the same time and worsened over about 8 hours. The pain subsided in the left arm, the first injection site, but continued for about 24 hours in current injection site - right arm. Severe body aches, mild headache, chills, fever (101 F), fatigue, no appetite: began about 6 hours after injection and continued for about 30 hours. Temperature normal and symptoms subsided about 48 hours after injection.
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| 71 | 2021-03-20 | diarrhea, abdominal pain upper |
fever; crushing body aches; diarrhea; headache; stomach pain; light sensitivity; not able to sleep f...
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fever; crushing body aches; diarrhea; headache; stomach pain; light sensitivity; not able to sleep from pain and disturbing thoughts, exhaustion; not able to sleep from pain and disturbing thoughts, exhaustion; Disturbing thoughts; This is spontaneous report from a contactable consumer (Patient). A 71-year-old female patient received first dose of BNT162B2 (COVID 19, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9264), via an unspecified route of administration on 06Feb2021 at 11:00 AM in Left arm at single dose for covid-19 immunisation. Patient was not pregnant. Other medical history was reported as none. No known allergies. Other concomitant medications in two weeks included 500 VitC &100 Vit D per day. No other vaccine in four weeks was reported. On 06Feb2021 at 23:00 (11:00 PM) the patient experienced fever, crushing body aches, diarrhea, headache, stomach pain, light sensitivity, not able to sleep from pain and disturbing thoughts, exhaustion. No covid prior vaccination. No covid tested post vaccination. No treatment for event. Outcome of the event was recovered. No follow-up attempts are possible. No further information is expected.
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| 71 | 2021-03-20 | nausea |
Swollen, bright pink cheeks, swollen tongue and interior of mouth, swollen neck, very weak voice and...
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Swollen, bright pink cheeks, swollen tongue and interior of mouth, swollen neck, very weak voice and very weak overall. Per order of a MD steroid dose pack taken as well as Benedryl 50 mg three times daily. Symptoms worsened, nauseated and temperature elevated 1.2-4 degrees above normal. Went to emergency room. Given intravenous solumedrol, Pepcid and Benedryl, then sent home on prednisone 40 mg a day for four days. Symptoms continued. MD took another steroid dose pack. Still worse after first four doses. Then took doctor's orders, prednisone 60 mg for three days, 40 mg for three days, 20 mg for three days then 10 mg for three days while continuing to take Benedryl 50 mg three times daily. I continue to take Benedryl for pink swollen cheeks. I am still weak and have swollen cheeks and neck as well as reduced voice.
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| 71 | 2021-03-21 | nausea |
extreme fatigue; faintness; severe headache; fever(100 degrees); nausea; shortness of breath; rapid ...
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extreme fatigue; faintness; severe headache; fever(100 degrees); nausea; shortness of breath; rapid heart beat; This is a spontaneous report from a non-contactable consumer. A 71-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN6205, via an unspecified route of administration, administered in left arm on 04Mar2021 as single dose for COVID-19 immunisation. Medical history included high blood pressure, pre-diabetic, penicillin allergies, allergies to sulfa drugs and bee stings. Concomitant medication included calcium. Historical vaccine included BNT162B2 on 11Feb2021 (lot number: EM9810) for COVID-19 immunization. On 04Mar2021, after 1 hour, the patient experienced shortness of breath and rapid heartbeat. At 12 hours, severe headache, fever (100 degrees) nausea, faintness, extreme fatigue 24 hours later, started to feel normal again 6 hours later. No treatment information was reported. The outcome of the events shortness of breath and rapid heartbeat was recovered on 04Mar2021, For events faintness, severe headache, fever (100 degrees), nausea and extreme fatigue was recovered on 05Mar2021. No follow-up attempts are possible. No further information is expected.
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| 71 | 2021-03-21 | nausea | Low grade fever, severe headache, chills, body aches, nausea, for 4 days |
| 71 | 2021-03-21 | nausea |
Within 10 minutes I became nauseous. I left the vaccination center and drove home becoming increasin...
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Within 10 minutes I became nauseous. I left the vaccination center and drove home becoming increasing ill. When I got home I went to bed and slept for two days, nauseous, weak, body aches, a rash under the vaccinated arm and on my back left side, headaches, fever, sleep interruption, vivid dreams. The left arm which had been vaccinated was extremely sore and remained so, just recently lessening. I believe I had Covid 19 in February of 2020 and while I got ill, did not experience the severity of illness that I experienced after vaccination. Now, 17 days later I continue to experience weakness, headaches and recently have had difficulty breathing after exercise. Although the rash has gone away, the left side is still itchy, but less so. I have discussed this with my Doctor and he informed me that my response to second shot may be stronger, although he did not tell me to avoid the second dose.
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| 71 | 2021-03-21 | vomiting, nausea |
Shaking chills, Fever (102.2), nausea, vomiting, mlalaise, head pressure, hard red rash at injection...
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Shaking chills, Fever (102.2), nausea, vomiting, mlalaise, head pressure, hard red rash at injection site, swollen nodes at injection site arm axilla
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| 71 | 2021-03-23 | abdominal pain, diarrhea, nausea, vomiting |
The patient initially presented (3/3/21) with headache, fevers, nausea, vomiting, diarrhea, myalgias...
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The patient initially presented (3/3/21) with headache, fevers, nausea, vomiting, diarrhea, myalgias, malaise. Patient related she was in her normal state of health and only started to feel poorly after she received her second COVID-19 vaccination three days earlier. She interestingly related that after her first Pfizer COVID-19 vaccination she had significant burning in her stomach that she noted but no other major symptoms and notably did not experience this severe burning in her stomach after the second dose. She denied any chest pain, current dyspnea, productive cough, sore throat, urinary symptoms, sick contacts. She has no history of C. difficile, no recent antibiotics, no recent spoiled foods, no recent travel, no history of radiation. She does have a history of GERD and has had gastritis with mild gastrointestinal bleeding in the past and undergone EGD negative for H. pylori infection. She also has undergone colonoscopies with polyps that have been removed and reported as tubular adenomas. As her hospitalization progressed, she was diagnosed with Severe Sepsis due to E. Coli bacteremia in setting of liver abscess, Cholelithiasis without acute cholecystitis, Atrial Fibrillation with rapid ventricular response, Transaminitis (which resolved). Patient was appropriately treated for these conditions. Also, her known uncontrolled diabetes was treated. Per an Infection Disease note on 3/9/21: The patient has had hx of biliary colic (self diagnosis) now with discovery of non-obstructive cholelithiasis on RUQ US it is plausible that the abscess originated from self limiting cholecystitis/cholangitis which would be consistent with recent abdominal pain exacerbated with oral intake. Difficult to state definitively any relation to COVID-19 vaccination, though may have resulted from associated dehydration. Additional COVID vaccine info (both Pfizer): first dose: 2/7/21 lot# EN 5318 second dose: 2/28/21 lot# EN6202
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| 71 | 2021-03-23 | difficulty swallowing, abdominal pain, nausea |
15 minutes after shot, numbness in lips, itchy mouth and throat, within about 5 more minutes throat ...
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15 minutes after shot, numbness in lips, itchy mouth and throat, within about 5 more minutes throat tightness, sensation of difficulty swallowing. Then abdominal pain, nausea, then feeling of something really wrong, I didn?t feel well, then got weaker and weaker, couldn?t lift arms, and felt extremely fatigued, trouble staying awake. Taken by ambulance to medical center. On route, ambulance stopped and another team came in. I was given epinephrine, zofran, Benadryl, and maybe a steroid? Not sure. When I arrived at hospital, t think I was given dexamethasone and famotidine. I was barely awake but could speak. Could not hold anything. After several hours, they woke me up, I felt myself again, and I was discharged. Following days I felt exhausted and dizzy, and had a headache. Took prednisone for five days.
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| 71 | 2021-03-23 | nausea | Headache, nausea and fever |
| 71 | 2021-03-23 | nausea |
First shot didn't feel it. Second shot I have a huge welt, red arm and swollen. Had migraine next d...
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First shot didn't feel it. Second shot I have a huge welt, red arm and swollen. Had migraine next day, low fever, nauseous. Today, March 24, 2021, I have a bump under my left arm - swollen lymph node. Arm is still very red. , I was very fatigue d next day.
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| 71 | 2021-03-23 | vomiting | Fever sweats chills vomiting disorientation |
| 71 | 2021-03-24 | nausea, decreased appetite |
severe pain in joints, wrists, elbows, ankles, hips/ ongoing headache behind eyes/nausea-joint pain ...
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severe pain in joints, wrists, elbows, ankles, hips/ ongoing headache behind eyes/nausea-joint pain wakes me from sound sleep, ongoing exhaustion, lack of appetite
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| 71 | 2021-03-24 | nausea, diarrhea |
Delirium/had taken over her body and was the cause of her illness; Severe weakness (could not walk o...
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Delirium/had taken over her body and was the cause of her illness; Severe weakness (could not walk or get out of a chair); Severe weakness (could not walk or get out of a chair); Nausea; Diarrhea; Mild headache; Blurred vision; Significant swelling at injection site which spread to full upper arm; Significant swelling at injection site which spread to full upper arm; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 05Mar2021 08:00 (lot number: EN6199) as single dose for COVID-19 immunisation. Medical history included osteoporosis (not bothersome), known allergies to some antibiotics, and felt dehydrated. The patient was not pregnant at the time of vaccination. The patient was taking other medications like grapefruit juice. The patient previously received first dose of bnt162b2 on 12Feb2021 (dose number 1, lot number: EL9267, administration time: 08:00 AM, vaccine location: left arm). No other vaccines received four weeks prior to COVID vaccination. On 05Mar2021 12:30, the patient experienced severe weakness (could not walk or get out of a chair), delirium (was convinced that (name) had taken over her body and was the cause of her illness), nausea, diarrhea, mild headache, blurred vision, significant swelling at injection site which spread to full upper arm over next three days and remains troublesome. Other symptoms (unspecified) lessened within two to three days and are no longer of concern. The AEs resulted in doctor or other healthcare professional office/clinic visit. Event 'significant swelling at injection site which spread to full upper arm' were treated with application of steroid cream (for arm only). Outcome of the events was unknown. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 post vaccination.
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| 71 | 2021-03-24 | nausea |
Day of vaccination arm was slightly tender. Day 6 my sleep was disturbed about 2 AM by a sick feelin...
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Day of vaccination arm was slightly tender. Day 6 my sleep was disturbed about 2 AM by a sick feeling (slight nausea and headache). Got out of bed at 5 AM with headache still present. Fever of 99.4 about 7AM. Headache continued on and off all day with 2 Tylenol. Fever went down but rose to 99.4 approx. 8PM no headache. Woke today, Thursday, at 5 with no headache but a fever of 100.4; went back to bed until 6. After a shower, my temp was down to 99. After exercise, it was 98. Feeling okay right now.
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| 71 | 2021-03-24 | nausea |
Client began complaining of feeling dizzy and was flushed and hot. 3 RNs were on scene assessing cli...
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Client began complaining of feeling dizzy and was flushed and hot. 3 RNs were on scene assessing client. Vitals were taken (180/90; 97% RA; hr 97. Client was given water and a fan was placed near pt. Client then began to complain of chest discomfort and burning in her throat like heartburn. She also began to feel nauseous. The dizziness began to get better. The client initially began to say she was feeling better, a couple minutes later she began to complain of chest pain/pressure. She described it as an elephant sitting on her chest. She also stated that her left shoulder began to hurt. She was also pale. Her vitals at this time were bp of 170/85; 02 of 97%; hr of 78. 911 was called at 4:10pm and arrived at 4:15pm. Chest pain was down to a 4 and nothing of significance was noted by EMS on the heart monitor. Client was given the option to be taken to the ER and she consented to transportation.
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| 71 | 2021-03-25 | vomiting, diarrhea |
Chills and 100 fever 7pm Fever persisted through 3-12-2021 Chills for 2 days Diarrhea and vomiting ...
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Chills and 100 fever 7pm Fever persisted through 3-12-2021 Chills for 2 days Diarrhea and vomiting started 10pm continued for 3 days. Terrible headache for two days
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| 71 | 2021-03-26 | nausea | Slight nausea, pain at injection site, fever, fatigue, headache |
| 71 | 2021-03-26 | vomiting, abdominal pain upper |
On Saturday Mar. 20th, I had my 2nd dose of the Pfizer vaccine. Approximately 3:00 AM, March 21, I ...
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On Saturday Mar. 20th, I had my 2nd dose of the Pfizer vaccine. Approximately 3:00 AM, March 21, I had a very severe reaction to the vaccine causing extreme pain in my belly and lower back. (Mainly my lower right back) The pain was exactly like my kidney stone pain...so painfully intense. Although trying to manage the pain with 2X 500 mg of acetaminophen every 6 hours, I was throwing up, pacing, rocking and becoming so weary of how was I going to get through this. A fever of 101.5 started sometime on Sunday and fluctuated but was no higher than 101.7. A heating pad helped to ease the pain and I was able to get some sleep until the flare up would start all over again. This continued throughout the day for 17 hours. By Monday , March 22, morning the intense pain was gone and my body was recouping. My stomach was achey from either the intense pain or the vomiting. I continured to run a fever of 101. until Tuesday afternoon, March 23.
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| 71 | 2021-03-27 | diarrhea, vomiting, nausea |
At 4 am one week after having received my second dose of Covid-19, I awoke very nauseated and procee...
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At 4 am one week after having received my second dose of Covid-19, I awoke very nauseated and proceeded to start vomiting. Around 7 am I began having uncontrollable diarrhea with weakness and dizziness following. No fever, just flu-like symptoms. With rest and liquids by mid-day I was starting to feel a little better.
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| 71 | 2021-03-27 | diarrhea |
Recd. 1st vaccine at 9:15 am, by 4:00 pm was not feeling well, went to bed. for the following 3 day...
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Recd. 1st vaccine at 9:15 am, by 4:00 pm was not feeling well, went to bed. for the following 3 days I had body aches, extreme chills, night sweats and nightmares, explosive diarrhia, extreme fatigue (slept 23 hours a day). Each following day I slept a little less, but the night sweats and fatigue lasted for 17 days. My temperature remained around 95.7. This is the sickest I have ever felt, even sicker than the Flu I had approximately 30 years ago! No reaction to 2nd vaccine!
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| 71 | 2021-03-28 | nausea |
Anaphylaxis; Respiratory distress; Sensation of throat closure; trouble breathing; Upper airway swel...
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Anaphylaxis; Respiratory distress; Sensation of throat closure; trouble breathing; Upper airway swelling; Tachycardia; Her tongue started symptomatic; sweating; Generalized erythema; general feeling of unwellness; energy is still very low; Generalized prickle sensation; Nausea; This is a spontaneous report from a contactable consumer (Patient) via telephone. A 71-year-old female patient (non-pregnant) received second dose BNT162B2 (Pfizer, Formulation: Solution for injection, Lot Number: EN9808) administered in Left Arm via an unspecified route of administration on 12Mar2021 at 13:30 at a single dose for COVID-19 immunization. Medical history included Cancer survivor, High BP, Allergies: Shell fish, Allergies: Latex, Allergies: Iodine, urticaria and insect bite/sting allergy, GI sensitivity to all antibiotic, Allergy: surgical scrubs, intestinal reaction to Pneumonia In 2017, (patient had intestinal reaction to Pneumonia Vaccine by (Name) for which she was administered antihistamine, IV Benadryl and Oral Benadryl). On 19Feb2021, patient took historical vaccine BNT162B2 (COVID 19, brand=Pfizer, Lot Number: EN6201) as 1st dose at 12:30 PM on left arm for Covid-19 Immunization and not received any vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. Patient did not receive any recent vaccines for any other conditions prior to the event being reported. Concomitant medication included hydrochlorothiazide taken for BP medication. The patient was not received any vaccine in four weeks. On 12Mar2021, patient experienced anaphylaxis 5 minutes after the vaccine 2nd dose which resulted to visit emergency room and was treated with EPI, Benadryl, Zophyin, DEX and Pepcid. Started with general feeling of unwellness. Her tongue started symptomatic, sweating, trouble breathing, they took BP they injected 1st dose of Epipen which had no improvement, however after 5 minutes given the 2nd dose and body reacted to Epinephrine. Then given Benadryl injection and transported to a different hospital. Corticosteriod DEX was administered. Patient was under ER observation for 5-6 Hours. On an unknown date in Mar2021, patient also experienced upper airway swelling, respiratory distress, difficulty breathing (without wheeze or stridor), energy was still very low, general feeling of unwellness, sensation of throat closure, her tongue started symptomatic, sweating, trouble breathing, tachycardia, generalized erythema, generalized prickle sensation and nausea. Therapeutic measures were taken as a result of anaphylaxis, respiratory distress, general feeling of unwellness, her tongue started symptomatic, sweating, trouble breathing. The outcome of all the events reported as recovering.
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| 71 | 2021-04-01 | nausea |
ear infection; nauseous; felt the room spinning; she thought she was having a stroke; lightheaded/ d...
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ear infection; nauseous; felt the room spinning; she thought she was having a stroke; lightheaded/ dizzy; This is a spontaneous report from a contactable consumer, the patient. A 71-years-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm on 10Mar2021 between 3:15PM-3:30PM (Batch/Lot Number: EN6206) (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included cessation of smoking as the patient stated that she quit smoking in either 2006 or 2007, ongoing blood pressure high from 1986, edema from 2012, hypothyroidism since about 2012-2013, high cholesterol for about 6-7 years and took simvastatin, potassium low from 2012 as she stated that she found out she had low potassium in 2012 when she had blood work done before she was scheduled for surgery and took potassium chloride (KLOR-CON), she used a walker a lot of the time and she stated that her weight fluctuated. She said that her current weight was the heaviest she had been. She said that she gained weight when she quit smoking. She said that she had hypothyroidism, and was old, which didn't help her weight. There were no concomitant medications. Family medical history relevant to adverse events (AE(s)) was not provided. The patient did not receive any other vaccines within four weeks prior to BNT162b2. The patient did not administer additional vaccines on the same date of BNT162b2. She mentioned that she received the first dose of BNT162b2 on 10Mar2021, a Wednesday. She said she didn't notice until the following Sunday on 14Mar2021 that she was lightheaded and dizzy. She said at first she thought she got up too fast, and that was what made her lightheaded. She specified on the Monday morning that it was really bad, she got lightheaded when she was got down on the floor at home doing her therapy and she felt the room spinning on 15Mar2021. She said that her symptoms got worse on Monday night on 15Mar2021 when she laid down in bed. She said that she tried to sit up in bed for as long as she could. She said as long as she was sitting up in bed, she wasn't lightheaded and the room didn't spin. She said she thought maybe she was getting an ear infection, so she took her fingers and plugged her ears for 30 seconds to see if that would help. She said that she had no pain or ringing in her ears. She said eventually she was able to lay down in bed and go to sleep. She said she didn't know what was going on. She said her symptoms were so bad on Monday (feeling lightheaded and the room spinning) that she thought she was having a stroke; and she had to grab on to the bed, got on her knees for she didn't know how long, and it did go away. She mentioned that every time she laid down, the room spun, and she had been dizzy and lightheaded ever since. She said that she was not expecting side effects after that much time had gone by from getting her BNT162b2. She said that the lightheadedness, and room spinning was still going on. She further said that as she was cradling the phone in her neck to do some work while she had been on hold for agents, she felt nauseous on 18Mar2021, but she moved around and she was fine now. She said that she thought the nausea was caused because she had been sitting at her desk working with the telephone cradled in her neck and her head looking down. The patient underwent lab tests and procedures which included potassium was on an unspecified date and weight: 175-180 lbs on an unspecified date as she stated that her weight fluctuated. She said that her current weight was the heaviest she had been. She said that she gained weight when she quit smoking. She said that she had hypothyroidism, and was old, which didn't help her weight. The adverse events, she thought she was having a stroke, lightheaded, dizzy, felt the room spinning and nauseous, did not require a visit to emergency room or physician office. The outcome of events, lightheaded, dizzy, felt the room spinning and nauseous, was not recovered, the outcome of events, she thought she was having a stroke and ear infection was unknown. The patient was due to get her second dose of BNT162b2 on 31Mar2021.
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| 71 | 2021-04-02 | nausea, diarrhea |
Palms of hands itched tremendously and turned bright red; Palms of hands itched tremendously and tur...
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Palms of hands itched tremendously and turned bright red; Palms of hands itched tremendously and turned bright red; chest congestion with coughing; chest congestion with coughing; Brain fog; fatigue; muscle weakness; nausea; slight diarrhea; Extremely sore arm up into neck; Extremely sore arm up into neck; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6200), via an unspecified route of administration in the left arm on 15Feb2021 11:00 at a single dose for COVID-19 immunization. Medical history included arthritis and patient was 17 years post endometrial, ovarian cancer, stage 1; she had no known allergies. Concomitant medication included ibuprofen (ADVIL) taken for arthritis. The patient did not have COVID prior vaccination, had no other vaccines in four weeks and was not pregnant. She received the vaccine at a Public Health Clinic. On 15Feb2021 11:45, the patient experienced chest congestion with coughing lasting 45 minutes, brain fog, fatigue, muscle weakness, nausea, slight diarrhea and extremely sore arm up into neck. Twice after the first dose; first onset was 45 minutes after first injection. She also experienced palms of hands itched tremendously and turned bright red, lasting 20-25 minutes. Three days after first dose (18Feb2021). The day of the first injection plus three days after, something happened every day. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6205), via an unspecified dose in left arm on 11Mar2021 11:00 at a single dose for COVID-19 immunization. The patient has not been tested for COVID post-vaccination. Outcome of the events chest congestion with coughing was recovered on 15Feb2021 12:30, palms of hands itched tremendously and turned bright red was recovered on 18Feb2021 and of the remaining events was recovering.
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| 71 | 2021-04-03 | abdominal pain upper, diarrhea |
upper gastric pain/terrible stomach pain; continuous diarrhea; experienced cramping; This is a spont...
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upper gastric pain/terrible stomach pain; continuous diarrhea; experienced cramping; This is a spontaneous report from a contactable Nurse, the patient. A 71-year-old female patient received the first dose of bnt162b2 (BNT162B2, Lot number unknown), via an unspecified route of administration on 18Feb2021 as a single dose in the arm (reported as "deltoid") for COVID-19 immunization. Medical history included multiple sclerosis from an unknown date. The patient responded "yes" when asked if she had been diagnosed with COVID-19 prior to the vaccination but also provided no details about this. The patient's concomitant medications were not reported. The patient experienced upper gastric pain/terrible stomach pain on an unspecified date with outcome of unknown, continuous diarrhea on an unspecified date with outcome of unknown and cramping on an unspecified date with outcome of unknown. The patient provided further details in that she reported that she woke the following morning after receiving the COVID-19 vaccine feeling as if she was having a heart attack, which was determined to be a result of upper gastric pain. She reported that she has experienced cramping and continuous diarrhea and she has been unable to leave the house except to receive medical treatment. She stated that she had had lab work (blood and stool samples) and everything has returned negative. She believes that the gastric pain and other symptoms are a result of her receiving the vaccine. She remarked that she works in healthcare and has been tested every week for COVID-19 prior to receiving the vaccine, and has not had any gastric pain issues prior to receiving the vaccine, never had any problem with her stomach, pain, diarrhea or anything related to diarrhea and stomach pain. The patient underwent lab tests and procedures which included stool culture negative on an unspecified date and "BMP, CMP and Hemoglobin - things like that" on an unspecified date the results of which were reported as "good" and SARS COV 2 test: negative on an unspecified date prior to this vaccine. Unspecified therapeutic measures were taken as a result of the events. Treatment for the events was reported as "just Tylenol."
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| 71 | 2021-04-09 | difficulty swallowing |
2 or 3 minutes after the vaccine I started feeling really hot. When the nurse came to ask me if I wa...
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2 or 3 minutes after the vaccine I started feeling really hot. When the nurse came to ask me if I was ok I told her that I needed some water. When I was drinking the water I was having problems swallowing. Then I started having problems breathing. I then broke down on a rash my skin was so red it looked like I was sun burned. My skin also peeled. Then I was taken into the emergency room by ambulance. They put an IV on me when I got to the hospital. They put a steroid & pepcid famotidine. They told me if I was not better by the next day to go back. My voice also goes occasionally & I still don't have energy.
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| 71 | 2021-04-11 | nausea, vomiting | Constant urination, constant dizziness, N/V, burning up all over |
| 71 | 2021-04-15 | decreased appetite |
71- year old woman with past medical significant for hypertension on 10 mg of Lisinopril daily for m...
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71- year old woman with past medical significant for hypertension on 10 mg of Lisinopril daily for many years. She had her first dose of Pfizer vaccine two weeks prior to admission (3/11/21). After her vaccination, patient felt unwell and dizzy in the mornings. She felt persistent fatigue and had a decreased appetite. The week prior to admission she noticed a decrease in her urine output. She denied NSAID use. Her primary care physician ordered blood week and her Cr was found to be 16.54 and BUN of 163, phosphate of 17.5. Her last known Cr prior to her admission was 18 months prior and was 1.17. She was asked to present to the emergency room. Renal ultrasound showed no hydronephrosis or stones. Urinalysis showed 1+ protein, spec grav of 1.023 with a urine protein/creatinine ratio of 0.09. Urine sediment was unremarkable. Her temperature was 95.6 and her BP was as low as 75/46 and she was put on a low dose of levo. CRP was 202.3. COVID was negative. CK wnl. ANA + to 1:160 (dsDNA, Smith, RNP, SS-A, SS-B all negative). Blood smear was negative. Cultures were all negative. Echo showed an EF of 68% with trivial pericardial effusion. Patient was oliguric, and then initiated on hemodialysis. Renal biopsy was performed. The biopsy consists of one fragment which is stained with H&E, PAS, Trichrome, Jones Silver, and HPS stains. Review of all stains reveals 12 glomeruli, one of which is globally sclerotic. The architecture of the kidney is well-preserved. There is interstitial fibrosis with proportional atrophy involving 10% of the biopsy tissue. There is a focal interstitial infiltrate consisting of lymphocytes involving <5% of the interstitium. The tubules show diffuse acute tubular injury. Calcium oxalate crystals are present in seven tubular profiles. The glomeruli show expansion of Bowman's capsule. The mesangium shows normal cellularity. The vessels show no abnormalities. IMMUNOFLUORESCENCE MICROSCOPY: Frozen sections are stained for IgA, IgG, IgM, C3, C1q, kappa, lambda, and fibrinogen. All immunofluorescence stains are negative. ELECTRON MICROSCOPY: Specimens are prepared for electron microscopy and semi-thin sections stained with toluidine blue are reviewed prior to thin sectioning for ultrastructural examination. Electron microscopy demonstrates patent capillary loops. The glomerular architecture demonstrates segmental corrugation of basement membranes with increase in lamina rara interna. No subepithelial deposits and no intramembranous deposits are identified. The tubules show dilated mitochondria and injury. There is segmental effacement of foot processes. There are no subendothelial deposits. Mesangial electron dense deposits are not identified. Patient received three dialysis treatments and Creatinine began to improved down to 1.46 within 8 days.
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| 71 | 2021-04-15 | vomiting, nausea |
Patient woke up on the 28th complaining of severe pain, nausea and vomiting. Was admitted to healthc...
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Patient woke up on the 28th complaining of severe pain, nausea and vomiting. Was admitted to healthcare facility and kept for observation overnight. On the 29th a CT was done and found bleeding in brain/stroke. Airlifted to healthcare facility where Craniotomy surgery was done.
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| 71 | 2021-04-23 | decreased appetite |
chills; slight temperature; body aches; headache; dizziness; extreme fatigue; no appetite; very slee...
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chills; slight temperature; body aches; headache; dizziness; extreme fatigue; no appetite; very sleepy; This is a spontaneous report from a contactable consumer. This consumer reported for herself that a 71-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number: UNKNOWN) via an unspecified route of administration, administered in Arm Left on 08Feb2021 13:30 (at the age of 71-year-old) as single dose for COVID-19 immunization. The patient medical history was not reported. No chronic health conditions were reported for patient. Concomitant medications included daily calcium and vitamin pill. The patient previously took ciprofloxacin and experienced drug hypersensitivity, historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number: UNKNOWN) via an unspecified route of administration, administered in Arm Left on on 18Jan2021 at 02:00 pm (at the age of 71-year-old) as single dose for COVID-19 immunization. On 08Feb2021 at 11:45Pm, the patient reported that he had these symptoms for the 2 days following vaccine included chills, slight temperature, body aches, headache, dizziness, extreme fatigue, no appetite and was very sleepy. It was reported that patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior or post to the vaccination. Patient did not receive any treatment for the events. Events were considered non-serious as reported. Patient was recovered with sequelae form all the events. Information regarding Batch/ Lot number have been requested
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| 71 | 2021-04-27 | nausea |
lost partial vision in my right eye which has been determined to be a AION; blood pressure elevated;...
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lost partial vision in my right eye which has been determined to be a AION; blood pressure elevated; weak; dizzy; nauseated; fever; headache; This is a spontaneous report from a contactable consumer (patient). This 71- year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EN6208), via an unspecified route of administration, on 11Mar2021 at 16:00 (at the age of 71-years-old) as a single dose for COVID-19 vaccination, in left arm. The facility where COVID-19 vaccine was administered was Public Health Clinic facility. Historical vaccine included: bnt162b2 (COMIRNATY, Solution for injection, Lot number EN6200) dose 1 on 18Feb2021 04:00 PM, for covid-19 immunization, left arm. No known allergies. The medical history included: Blood pressure abnormal. Concomitant medications included: Prozac, Inderal, Atorvastatin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Mar2021 09:00 am, Day after 2nd injection, she felt weak, dizzy, nauseated, fever, blood pressure elevated and had an extremely severe headache. That evening I lost partial vision in my right eye, which has been determined to be AION. Vision has not returned at one month out. Event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Treatment included: Blood pressure monitoring and return 13Apr2021. The clinical outcome of the events was not recovered. The patient was not tested for COVID-19 after the vaccination. No follow-up attempts are possible. No further information is expected.
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| 71 | 2021-04-28 | abdominal pain upper, nausea, diarrhea |
muscle pain; back pain; fever; felt panicky; neck pain; runny nose; Stinging pain in left leg / pain...
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muscle pain; back pain; fever; felt panicky; neck pain; runny nose; Stinging pain in left leg / pain in left arm; pain in the joints; Red circle around injection site; Weak feeling in arms and legs; body feels heavy; dizziness; Very exhausted; Nausea; Diarrhea; Some cramping in stomach; Brain Fog; Body aches; headache; itchiness; Left arm sore at injection site; anxiety; not feeling well; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 28Feb2021 at 15:00 (at the age of 71-years-old) as a single dose for COVID-19 immunization. Medical history included diabetes diagnosed 15 years ago, obesity, asthma with bronchitis as a child, allergy to other medications, anaphylactic reaction to sulfas twenty years ago (also reported as 50 years ago), muscle hurt/sore arm usually when she got a flu vaccine (unspecified) once a year, allergies to makeup and clothes (diagnosed at least 50 years ago), heart beats fast, low thyroid and borderline high cholesterol. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for 30 years for low thyroid, nebivolol hydrochloride (BYSTOLIC) taken for 25 years, rosuvastatin calcium, (CRESTOR OD) taken for 2 years for borderline high cholesterol and insulin (unspecified). The patient did not receive any other vaccinations on the same day or within 4 weeks of the vaccine. The patient previously took paracetamol (TYLENOL) and diphenhydramine (BENADRYL) as pre-medication since she had allergic reactions to some things and would get this before the flu shot; as well as salbutamol sulfate (PROAIR HFA) for runny nose and coughing. The patient had the first dose of the vaccine on 28Feb2021, and "they" wanted to give her diphenhydramine (BENADRYL) after the vaccine but could not since she was driving. After the vaccination, the patient was not feeling well for 2 days (as of an unspecified date) and thought she was getting better. On 28Feb2021, the patient experienced anxiety. She was more anxious when "that stuff" appeared on the news on day 4 and 5 after the vaccine. She took a small dose of clonazepam 0.5 mg, dividing the pill in 4 pieces as she never took the whole thing. She took it when she got extremely anxious and tried not to take it because it can be habit forming. She may take it 3 times a week or in the middle of the night. It helped a little bit, but she still felt panicky and upset. She woke up feeling anxious. She did not normally take these medications. The patient reported that she experienced headache (constantly several times a week) and left arm sore at injection site, itchiness/ itching all over body (not constant but still happening) from 28Feb2021. On Mar2021 (day 4), the patient experienced dizziness (comes and goes and was not constant like it was), was very exhausted, nausea (tapered off after 2 weeks), diarrhea, some cramping in stomach, brain fog (still struggling and forgets to take her insulin, not as bad as when she first noticed), body aches. At first, the body aches were a pain in the left knee and left elbow and then moved to various joints and muscles. The left knee and elbow pain persisted without ever going away, but also moved to different areas. The calf muscle in left leg pain is also constant. The patient experienced pain in the joints and stinging pain in left leg (below knee down to ankle) from 04Mar2021, runny nose (tapered off) from 07Mar2021, and on an unspecified date muscle pain, back pain, fever, neck pain, pain in left arm. On Mar2021 (two weeks after vaccination), the patient had a red circle around injection site not all the way filled in, but rim around where she got shot. On Mar2021 (3 weeks after vaccination), the patient experienced a weak feeling in arms and legs and other times when she stood up her body felt heavy (persistent but not every day). The patient spoke with her physician who did not believe the patient about the symptoms and recommended she seek psychiatric help. The patient had not received the second dose of the vaccine because her physician did not recommend it. She was upset because her physician told her she could not get the second shot. She was having worsening anxiety because she had not been feeling well for so long, going on 7 weeks. She visited her physician's office 6,7, or 8 times. The patient underwent lab tests and procedures on unspecified dates which included an ultrasound of the leg (did not have a blood clot), an X-Ray of the back (unknown results) and an MRI of the back (did not find anything) to determine the pain. The physician thought it might be a compression fracture, but the MRI did not show anything. The patient was tested for antibodies on 05Apr2021 and had zero antibodies. The clinical outcome of anxiety, felt panicky, neck pain was unknown; dizziness, headache, runny nose, itchiness, pain in the joints, muscle pain, back pain, fever, very exhausted, nausea, diarrhea, some cramping in stomach, brain fog, body aches, stinging pain in left leg / pain in left arm, weak feelings in arms and legs, body feels heavy, left arm sore at injection site, red circle around injection site, not feeling well, was resolving. No follow-up attempts are needed. Information on lot/batch cannot be obtained.; Sender's Comments: Linked Report(s): same patient, different vaccine dose/event
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| 71 | 2021-05-13 | difficulty swallowing |
Throat constriction could not swallow; Throat constriction could not swallow; Blood pressure high 22...
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Throat constriction could not swallow; Throat constriction could not swallow; Blood pressure high 225/170; It wasn't right on site; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 71-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6199, Expiration date was not reported), via an unspecified route of administration in right arm on 01Mar2021 09:15 as first dose single for covid-19 immunisation. Medical history included migraines, fibromyalgia, arthritis, Known allergies to tetracycline, Iodine, Ecklonia Kurome, degenerative joint and Osteoarthritis. Concomitant medications included sumatriptan, oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET), rosuvastatin calcium (CRESTOR) all are taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfacetamide and experienced allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The patient experienced throat constriction could not swallow/blood pressure high 225/170 on 08Mar2021 02:00. Patient received the 1st dose of the Pfizer vaccine on 08Mar2021. She had adverse events after the 1st dose and was rushed to the ER, but they were able to stabilize her. She is wondering if she would be a candidate for the 2nd dose which is scheduled on 12Apr2021. She also mentioned that she had a check-up, and she was told that she can get the 2nd dose. She was asked to bring her EpiPen with her and take some antihistamine prior to getting the 2nd dose. She was asking maybe Pfizer has some advice for her as well. Patient ended up being taken in the ambulance to ER with an adverse reaction. It was a delayed reaction. It was not right on site on an unspecified date in Mar2021, right after I had the shot that it was a delayed reaction and I ended up in emergency in the ER. As per the reporter seriousness criteria reported as medically significant. Patient received treatment of IV drip methylprednisolone sod succ (Solution-MEDRO) for adverse events. The patient underwent lab tests and procedures which included blood pressure: 225/170 on 08Mar2021. The outcome of the event vaccination site discomfort was unknown and not recovered for other events. Information on Lot/Batch number was available. Additional information has been requested.
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| 72 | 2021-01-04 | nausea |
arms hurting; Lymph nodes hurting on the left side; chills in which she is hot and cold and she coul...
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arms hurting; Lymph nodes hurting on the left side; chills in which she is hot and cold and she couldn't get warm at first and then she is cold; high blood pressure/blood pressure was high 190/116; big toes hurting; nausea; dizziness; feeling weakness legs/Leg feeling weak; This is a spontaneous report from a contactable other HCP reporting for herself. A 72-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: CJ1686), via an unspecified route of administration in the right arm on 28Dec2020 15:00 at single dose for COVID-19 immunisation. Medical history included breast cancer on the left side, hypertension, hiatal hernia, glaucoma, heart disease, hypertension, lymphadenectomy (lymph nodes being taken out was about 20 years before) and headache from 27Dec2020. She was working Sunday into Monday morning and she went to the Director of Nursing, and said she has a Headache on the left side of the temple, and so she went to eye doctor, and he had a test order ESR and so she has a hemorrhage in the left eye, and show she doesn't know if this could be bringing on some of the side effects she was speaking about, like the nausea and the migraine. She has had No positive test for COVID prior to the vaccine, she must have had about 20 tests and all were negative. She has not had any Antibody tests. She had pneumonia vaccine maybe in the last 5-3 years and flu vaccine in Oct2020 and she experienced achy arm. On 28Dec2020 the patient experienced leg feeling weak (about 15 minutes after injection), nauseous at 21:00, dizziness. On 29Dec2020 the patient experienced arm hurting (in the morning), lymph nodes hurting on the left side, chills, blood pressure was high 190/116, big toes hurting. The patient was calling to ask if these side effects she was experiencing were normal. On 29Dec2020 the patient underwent ESR with unknown results. The patient reported that her arm hurting began on 29Dec2020 in the morning. The breast cancer diagnosis was prior to the vaccine as well as her lymph nodes being taken out was about 20 years ago. Her Lymph nodes hurting on the left side started on 29Dec2020 in the morning. Her Leg feeling weak started right after the injection, about 15 minutes after on 28Dec2020. The chills started on 29Dec2020 in the morning in which she couldn't get warm. Her feeling nauseous started on 28Dec2020 in the evening like 9 PM. The Temperature 98.1 was her current temperature taken right before the call, as well as her blood pressure. Her feeling dizzy started after getting vaccine on 28Dec2020, she was fine to drive home, but then again on 29Dec2020 in the morning she felt it also. Her legs felt funny like rubbery. The big toes hurting started an hour before, on 29Dec2020 it woke her up since it was jabbing. The outcome of the events was unknown.
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| 72 | 2021-01-07 | nausea, diarrhea, flatulence |
Day of injection - sore injection site Day 1 post injection - headache, nausea Day 2 post injection ...
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Day of injection - sore injection site Day 1 post injection - headache, nausea Day 2 post injection - nausea Day 3 post injection - increasing nausea, gas Day 4 post injection - Loose stool x 7, gas, nausea
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| 72 | 2021-01-08 | vomiting, nausea |
Had COVID vaccine and was being monitored. At 10:10am, she became nauseous and started vomiting. Sh...
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Had COVID vaccine and was being monitored. At 10:10am, she became nauseous and started vomiting. She felt short of breath and difficulty breathing. Felt dizzy/lightheaded. History of anaphylaxis and allergies. History of COPD/asthma. Due to vomiting, short of breath and dizziness, given epipen at 10:15am and called 911. Continued to monitor and developed worsening shortness of breath. Second epipen given at 10:25am.
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| 72 | 2021-01-08 | vomiting | Vomiting, Chills |
| 72 | 2021-01-11 | nausea |
Fever 101.9, chills, nausea, body aches, for a day (Thursday), felt better on Friday and ok on Satu...
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Fever 101.9, chills, nausea, body aches, for a day (Thursday), felt better on Friday and ok on Saturday.
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| 72 | 2021-01-13 | decreased appetite |
No reactions immediately after vaccine was given. Resident has dementia, has had multiple hospitaliz...
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No reactions immediately after vaccine was given. Resident has dementia, has had multiple hospitalizations related to a renal stone recently. Had a tooth that was bothering her, went to see her dentist and it was extracted on 1/6/21. On 1/10 they noted feet and ankles are dark purple with white splotches appears to be mottling. Minimally responsive to voice and touch. Not eating. Compassionate visit with family. Family did not want hospice, did not feel it was needed, said, what more could they do for her than you're already doing? On 1/11 at 1950 was determined to be deceased.
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| 72 | 2021-01-13 | nausea, decreased appetite |
Injection site pain; the arm felt heavy; Aches and pains/the pain extended from her shoulder down to...
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Injection site pain; the arm felt heavy; Aches and pains/the pain extended from her shoulder down to her elbow; aches and pains/pain went from the injection shoulder and spread to the middle of her spine; aches and pains/pain went from the injection shoulder and spread to the middle of her spine; Nausea; total loss of appetite; stated that she gained 10lbs, but she is very physically active.; either not making blood or there was an interference; she was freezing/she woke up cold and could not get warm/ felt cold; she had a little headache; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685, Expiry Date: Mar2021), intramuscular at left arm on 31Dec2020 at single dose for covid-19 prophylaxis. Medical history included low sodium, Covid-19 in Nov2020 (She had felt sick for a week and on 13Nov2020 she went to the ER and they did blood tests and she could not eat or drink for 3 days. She stated that she had 4 different IV fluids going and one of them was sodium and the other was for nausea), blood did not clot properly, broke her back. There were no concomitant medications.The patient had a unique reaction after receiving the Covid-19mRNA Vaccine. She clarified that she never had a reaction to a shot before. She received the vaccine on 31Dec2020 and was fine for the first 20 hours. She said that the next morning on 01Jan2021 at 0600 she woke up cold and could not get warm. She said that she spent the next 24 hours to where she kept adding clothes and blankets to keep warm. She stated that she was freezing and the she felt like the interior of her body was freezing even down to her toes felt cold. She also had injection site pain and the arm felt heavy and stated that the pain extended from her shoulder down to her elbow. She stated that the injection site pain was kind of delayed. She had aches and pains. She said that some of the pain went from the injection shoulder and spread to the middle of her spine. She had nausea and total loss of appetite and could not even eat. Her aches and pains after the vaccine were similar aches like she had with the Covid. She said that she had a terrible headache when she had Covid though. She stated that after the 24 hours of receiving the vaccine she had a little headache, but she took a migraine pill for it. She said that she was able to shed clothes, but she could not take a shower, but within 24-36 hours she was back to normal like it all never happened. She said that was when she figured out it was like her hemorrhaging with one of her childbirths. She explained that she had 3 children and hemorrhaged with each of her child births and was going into shock with one of them and felt this freezing sensation due to blood loss. She thought that her reaction to the vaccine was so bad that she was either not making blood or there was an interference. There was some kind of weird interruption. She said that her blood clots break down from minutes to hours after her child birth or with dental procedures. She had a PAI-1 deficiency or Plasminogen Activator Inhibitor-1 deficiency. She said that there was also something deeper that her doctors had not figured out yet too. She said that her blood did not clot properly. She said that she did not bruise or anything, but she was not allowed to have internal surgery without a transfusion. She said that her doctor's started to figure this all out after she broke her back before. She went to a hematologist and had her counts checked regularly. She said that she was being studied by 127 different clinics. She gained 10lbs, but she was very physically active. This was her first dose of teh vaccine. She said that her doctors told her that she needs to be under 48 hours of observation if she gets the second vaccine. Her primary care physician recommended that she did not take another mRNA vaccine. She said that she was taking their advice and canceled her second dose appointment. She said that when she had Covid-19 they did a Chest x-ray on 13Nov2020 and she had low sodium. She said that they gave her tramadol at the hospital for her headache, but she had already taken 3 migraine pills that day. She had already had her flu shot and read somewhere on a website, that mRNA vaccines might cause unstable anticoagulation. She wondered if it could be possible that Covid-19 antibodies interfered with her injection? The outcome of events was unknown.
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| 72 | 2021-01-14 | abdominal pain, nausea, diarrhea |
Abdominal cramping, belly ache, nausea, diarrhea, headache in the night. Queasy in the morning. Sl...
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Abdominal cramping, belly ache, nausea, diarrhea, headache in the night. Queasy in the morning. Sluggish. Bland diet - rest. It seems to be resolving.
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| 72 | 2021-01-14 | nausea |
At facility - tingling & numbness on lips and tongue - predominantly on the left side - this has con...
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At facility - tingling & numbness on lips and tongue - predominantly on the left side - this has continued with occasional spreading to nose & eyes & sometimes on other side of face - it waxes & wanes Same day - headache, dizzy, exhausted - lasted 2 days Next day - nausea, intestinal discomfort - continuing mildly Mild headache continuing
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| 72 | 2021-01-17 | diarrhea, vomiting, nausea |
Within an hour of the vaccine, pt started having nausea and vomiting. She later developed diarrhea ...
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Within an hour of the vaccine, pt started having nausea and vomiting. She later developed diarrhea that lasted for several hours.
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| 72 | 2021-01-17 | vomiting |
I began vomiting at 3 AM, and continued vomiting often until 9:30 AM on 1/18/21 I am hoping it was n...
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I began vomiting at 3 AM, and continued vomiting often until 9:30 AM on 1/18/21 I am hoping it was not a reaction to the vaccine but I thought I should report it just in case.
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| 72 | 2021-01-18 | decreased appetite |
joint pain persisted; confusion; anorexia; chills began 19 hours after injection; low-grade fever (1...
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joint pain persisted; confusion; anorexia; chills began 19 hours after injection; low-grade fever (100.6); hypotension; hypoglycemia; lethargy; the 2nd dose on 08Jan2021 /1st dose on 20Dec2020; This is a spontaneous report from a contactable Physician (patient). This 72-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 08Jan2021 05:00 PM at single dose (lot number: EK9231) for covid-19 immunisation. Medical history included diabetes, idiopathic encapsulating peritonitis and known allergies to Latex. Concomitant medications included insulin glargine (LANTUS), insulin lispro (HUMALOG), tamoxifen, apixaban (ELIQUIS), simvastatin. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) at left arm on 20Dec2020 01:00 PM for covid-19 immunisation. The patient experienced chills began 19 hours after injection, followed by low-grade fever (100.6), hypotension, hypoglycemia, lethargy, confusion and anorexia on 09Jan2021 12: 00 PM. Illness lasted 17 hours, treated with fluids, anti- inflammatories and sleep. Some new joint pain persisted. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event joint pain persisted was unknown. Outcome of other events was recovered/resolved with sequel.
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| 72 | 2021-01-20 | abdominal discomfort |
Community member receiving covid vaccine c/o abd discomfort and urge to defecate with left arm itchi...
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Community member receiving covid vaccine c/o abd discomfort and urge to defecate with left arm itching (vaccine receive in right arm). Escorted to bathroom without incident, no rash noted to either arm. Escorted back to monitoring area where approx 15 min later she continued to c/o abd discomfort and "crumminess." ED Charge RN contacted, ED staff transported patient via wheelchair to ED.
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| 72 | 2021-01-24 | nausea |
leg aches, chills, joint pain, malaise started on 3rd day after injection. Today is day 8 after inj...
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leg aches, chills, joint pain, malaise started on 3rd day after injection. Today is day 8 after injection & still have malaise and nausea. Had headache yesterday and day before. Also woke up at 3AM yesterday and day before in a cold sweat. Some leg ache today as well. Have been taking 2 extra strength Tylenol every 6 hrs which sometimes gives relief but not always.
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| 72 | 2021-01-24 | nausea |
1st covid shot on 1/16/21. Then on 1/19/21 I had ortho inject a steroid in my thumb. Right after t...
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1st covid shot on 1/16/21. Then on 1/19/21 I had ortho inject a steroid in my thumb. Right after the steroid shot, I started reactions---Severe headache, chills, nausea, cough, upper chest pain, severe weakness, blood pressure up and down. Went to family doctor 1/22 and covid shot in office showed negative. Worse on 1/24/21 and went to ED. They did a chest x-ray, CTA chest, lots of bloodwork and covid test that took 2 hours to receive results. All was negative except the D-dimer test. Thye thought it might be a result of the 2 injections within days of each other.
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| 72 | 2021-01-24 | nausea |
1 week after the shot, I started itching from head to foot. No outward rash, just non-stop itching....
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1 week after the shot, I started itching from head to foot. No outward rash, just non-stop itching. A little nausea at times. I took benadryl which helped a little for a short time.
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| 72 | 2021-01-24 | nausea |
chills, low grade fever, aches, pain in arm, slight nausea, headache started about 12 hours after re...
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chills, low grade fever, aches, pain in arm, slight nausea, headache started about 12 hours after receiving shot lessening after about 48 hours
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| 72 | 2021-01-25 | nausea, abdominal discomfort |
At vaccine site, had numbness; tingling on lips and tongue on left side of face; tingling on left si...
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At vaccine site, had numbness; tingling on lips and tongue on left side of face; tingling on left side of face; headache/Mild headache; dizzy; exhausted; GI - mild naseau; intestinal discomfort; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL32216), via an unspecified route of administration on 09Jan2021 10:00 at SINGLE DOSE at arm left for covid-19 immunisation. Medical history included known allergies: yes. Concomitant medications included levothyroxine sodium (SYNTHYROID), lisinopril, fexofenadine hydrochloride (ALLEGRA), progesterone (PROMETRIUM [PROGESTERONE]), and "PULMICO". On 09Jan2021, it was reported that At vaccine site, had numbness, tingling on lips and tongue on left side of face. This has not subsided, sometimes spreading, waxing & waning. Same day - headache, dizzy, exhausted - two days. GI - mild naseau (nausea), intestinal discomfort - on going. Mild headache continuing. The patient did not receive treatment for the events. The outcome of the events was reported as recovering.
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| 72 | 2021-01-26 | diarrhea |
Severe Headache - for 2 days and took Tylenol, Face Swelling - for 1 day and took Benadryl, ...
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Severe Headache - for 2 days and took Tylenol, Face Swelling - for 1 day and took Benadryl, Diarrhea - for 1 day, Arm swollen and hot, - for 1 day, Body muscle pain - for 3 days
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| 72 | 2021-01-27 | abdominal discomfort, abdominal pain upper |
Started with stomach twinges, went away ,5minutes later another hit. Went to eat and when finished m...
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Started with stomach twinges, went away ,5minutes later another hit. Went to eat and when finished meal I started to get double over pain we went home and that took 15 min. The pain was sharp and continues for a total of 30 min. I payed down with heat pad then it went away .since then I feel very tired, no energy,and my arm still feels weak and sore after the first shot .today I go for the second one.
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| 72 | 2021-01-27 | diarrhea | DEVELOPED SWOLLEN UPPER ARM, SORENESS, AND DIARRHEA. |
| 72 | 2021-01-27 | nausea |
1st day after Vaccine, soreness on injection sight. 3rd day Fatigue and light headiness, 4th day he...
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1st day after Vaccine, soreness on injection sight. 3rd day Fatigue and light headiness, 4th day headache, nausea, mind fog and imbalance, 6th day ulcers on my tongue, very painful for 3 days, severe crippling muscle cramps in my toes on my right foot during the night while sleeping. hives and red blotches. I didn't feel like myself for at least 12 days after the vaccine. I'm a little nervous about today, 01/28/2021, I took my 2nd dose this morning. Hope I don't have to report anything on the 2nd.
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| 72 | 2021-01-28 | nausea |
awful burning in the chest/pain in her chest; horrible pressure and pain in her chest; nausea; felt ...
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awful burning in the chest/pain in her chest; horrible pressure and pain in her chest; nausea; felt woozy; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3246), via an unspecified route of administration in the right arm on 13Jan2021 at 17:39 at a single dose in the hospital for covid-19 immunisation. Medical history included anxiety, seizures, and high cholesterol. She passed out last summer and they put her in the hospital from 31Aug2020 and ran all kinds of tests. In the end, they said she only had a few PVCs (premature ventricular contractions) and she doesn't need to see the doctor for a year. Mentioned she also has chronic bronchitis and this is related to having low platelet count and low immunity. All of these events predate treatment with Pfizer COVID 19 vaccine. Concomitant medication included amlodipine, atorvastatin for high cholesterol, clonazepam for seizures, escitalopram for anxiety, levothyroxine sodium for thyroid, and mirtazapine for sleep; all were ongoing. Stated that she had something weird happen after her injection about four hours after the shot. She received the first dose of the Pfizer COVID 19 vaccine on 13Jan2021 at 17:39 in the right arm. About three or four hours later on 13Jan2021, she was getting ready for bed and when she sat down and leaned over she had a god awful burning in her chest and nausea. She was going to take baking soda but when she sat up she had horrible pressure and pain in her chest and felt woozy so she sat on the floor and then the pain started to radiate through her arm and into her neck. The horrible pain and pressure in her chest felt like something was sitting on her chest and the bad pain in her chest was going into her arm and a little into her neck. She laid real still on the floor, and did a lot of praying, and then 20 minutes later it totally stopped. She got up slowly and finished getting ready for bed and was fine. She was just hoping they will still let her get the second shot. The whole event only lasted 20 minutes and when it was over it was completely gone. She did tell her husband when he came home. She was alone when this happened. The patient wanted to know if she can receive second dose of vaccine. She stated it almost felt like a heart attack. She was planning to get the second dose on 03Feb2021. Wanted to know if her effect will preclude her from getting the second dose of the vaccine. Outcome of the events was recovered on 13Jan2021.
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| 72 | 2021-01-31 | diarrhea, abdominal discomfort, nausea, vomiting |
Headache, upset stomach, nausea and diarrhea, and her face was sunburn red and started Friday the 29...
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Headache, upset stomach, nausea and diarrhea, and her face was sunburn red and started Friday the 29th and still sick. throwing up every 15 to 20 mins. Called Dr. on Sunday and was told to take aspirin and Tylenol
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| 72 | 2021-01-31 | nausea | Nausea, dizziness lightheadedness |
| 72 | 2021-01-31 | nausea | chills, fever, nausea, fatigue, body aches for six days so far |
| 72 | 2021-02-01 | decreased appetite, vomiting, nausea |
Felt like had the flu; Lethargic; Nauseated/ Nausea; overall unwell feeling, she did not feel well a...
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Felt like had the flu; Lethargic; Nauseated/ Nausea; overall unwell feeling, she did not feel well at all; she slept constantly/sleeping; Tiredness; did not eat; felt like throwing up; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ELI283) via an unspecified route of administration on the left arm on 15Jan2021 10:15 at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. She mentioned she felt nauseated on 15Jan2021. She woke on 16Jan2021 and felt like she had the flu. From Friday until Sunday like until 12:45 she slept constantly. She experienced tiredness. She did not eat. She was just sleeping and felt like throwing up (Jan2021). She started the feel the nausea the same day she got the vaccine. She blew it off thinking it was nothing. However, the next morning she felt like she had the flu. She was feeling lethargic. The nausea went away yesterday afternoon. On 19Jan2021 was the first day she felt like herself. She felt like she had the flu soon as she woke up. She had this overall unwell feeling, she did not feel well at all in Jan2021. There were no additional vaccines administered on same date of Pfizer suspect. The events did not require a visit to the emergency room and physician's office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No relevant tests done. The patient recovered from the events nauseated/ nausea and felt like had the flu on 18Jan2021; lethargic on 19Jan2021. Outcome of the other events was unknown.
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| 72 | 2021-02-01 | indigestion |
her right arm began having a shooting pain that went up to her neck and left breast; her right arm b...
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her right arm began having a shooting pain that went up to her neck and left breast; her right arm began having a shooting pain that went up to her neck and left breast; her right arm began having a shooting pain that went up to her neck and left breast; Indigestion; dry mouth; blood pressure was high; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL8982) via an unspecified route of administration on the left arm on 15Jan2021 at a single dose for COVID-19 vaccination. Medical history included ongoing heart murmur. There were no concomitant medications. She received the first dose of COVID vaccine on 15Jan2021 in her left arm. Patient stated that 15 minutes after receiving COVID vaccine her right arm began having a shooting pain that went up to her neck and left breast. She was given 4 Aspirin and a Nitroglycerin tablet. She was then transported to (Institute Name Withheld) by ambulance from vaccination facility. While at the hospital blood work was obtained and her pancreas was checked. Patient stated she was there for three hours. She would like to know if she should receive the second dose of the COVID vaccine? Reported she had an adverse event 15 minutes after receiving her first dose of the COVID-19 Vaccine. She said she had pain in her right arm. She said the pain went up to her neck. She said she had pain under left breast. She said she felt like she had indigestion. She said she was told to chew 4 aspirins, clarifying she was given 4 aspirins by the ambulance staff that was at the scene to treat her. Reported she was told her blood pressure was high. She said she doesn't know what her blood pressure reading was because the ambulance staff would not tell her. Reported she noticed she had a dry mouth while she was being transported in the ambulance to the hospital. Reported she was transported by ambulance to the hospital emergency room in (City Name Withheld), (State Name Withheld). She said she was treated and released from the emergency room. Reported her neck pain was gone first, but she still felt like she had indigestion while being treated in the emergency room. Treatment: Reported the hospital staff had her drink something, and then her indigestion, and arm pain went away. She said the hospital did blood work and checked her pancreas. She said she has no information on her blood work results, saying the emergency room doctor didn't share her results with her. She said the emergency room doctor only mentioned that he was checking her pancreas. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of Pfizer suspect. The events did not require a visit to physician office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the event pain in arm was recovered in 15Jan2021, patient recovered from neck pain, breast pain, indigestion and dry mouth in Jan2021; and unknown for the other event.
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| 72 | 2021-02-02 | diarrhea | Muscle aches, soreness at site of vaccine, diarrhea |
| 72 | 2021-02-02 | nausea |
1st shot no issue 2nd shot - initial arm soreness, increasing in intensity in evening Morning after ...
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1st shot no issue 2nd shot - initial arm soreness, increasing in intensity in evening Morning after nausea, body aches, headache, fever peak at 101.5 -treated with anti-nausea Ondansetron ODT 8mg, Tylenol 500mg -
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| 72 | 2021-02-02 | vomiting, diarrhea |
Headache, vomiting ,diarrhea, aching joints all over, low grade fever, slight cough ,sore throat, no...
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Headache, vomiting ,diarrhea, aching joints all over, low grade fever, slight cough ,sore throat, no taste or smell.
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| 72 | 2021-02-05 | nausea | Awakened by terrible chills, nausea, and sweats. |
| 72 | 2021-02-07 | decreased appetite, nausea, vomiting |
Nausea; throwing up bile; no appetite; This is a spontaneous report from a contactable consumer (pat...
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Nausea; throwing up bile; no appetite; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received BNT162B2, via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunization. Medical history included hypertension. No COVID prior vaccination. Concomitant medications included azilsartan kamedoxomil (EDARBI), troxipide (PRESTONE), and torsemide (TORSEMIDE). The patient previously took erythromycin and experienced drug allergy. Patient experienced nausea and throwing up bile, no appetite on 21Jan2021. No treatment received for these events. No COVID tested post vaccination. Outcome of the events was not resolved. Information on the lot/batch number has been requested.
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| 72 | 2021-02-07 | indigestion, nausea, diarrhea, vomiting |
1/21/2021, 4 pm, Covid-19 first shot, Pfizer, Lot EL3246 On 1/24/2021 at 5 am I had bad heartburn s...
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1/21/2021, 4 pm, Covid-19 first shot, Pfizer, Lot EL3246 On 1/24/2021 at 5 am I had bad heartburn so I got out of bed, took a couple of TUMS and sat in chair , At 6 am I went to get in bed and felt nausea and started to go to the bathroom but ended up fainting. When I came to I started vomiting., Then my husband had to help me off the floor and get to the bathroom. I was vomiting and had Diarrhea. My temperature was normal. When symptoms subsided in about a half hour time I realized my right foot, leg and knee hurt. At approximately 1 pm my daughter insisted that I go to the ER, where I was treated.They ran a bunch of test but did not find anything seriously wrong with me and sent me home.
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| 72 | 2021-02-07 | difficulty swallowing |
Patient felt difficult swallowing at observation area. Able to talk clearly. O2 Sat 100%. Benadryl g...
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Patient felt difficult swallowing at observation area. Able to talk clearly. O2 Sat 100%. Benadryl given at 1127. Patient arrived at ED a few hours after but symptoms had resolved. Given steroids and prescriptions for managing allergic reaction at home if needed.
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| 72 | 2021-02-07 | nausea, vomiting |
pt stated that her left arm was very sore and then she woke up in a hot sweat, had chills, headache,...
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pt stated that her left arm was very sore and then she woke up in a hot sweat, had chills, headache, and was nauseated. She took medicine for nausea but then she felt even more sick and then vomited. Pt stated she is still nauseated and will contact her PCP if she doesnt get to feeling any better.
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| 72 | 2021-02-07 | nausea |
Patient received COVID vaccine and felt dizzy and nauseating 10 minutes after. Later developed pal...
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Patient received COVID vaccine and felt dizzy and nauseating 10 minutes after. Later developed palpitation. Vital and O2 Sat stable. MD on site examined the patient and triaged to send patient to ED. Symptoms recovered when presenting to ED.
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| 72 | 2021-02-08 | diarrhea |
Diarrhea with fecal urgency and incontinence lasting for 5+ days starting 2-3 days after the injecti...
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Diarrhea with fecal urgency and incontinence lasting for 5+ days starting 2-3 days after the injection.
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| 72 | 2021-02-08 | difficulty swallowing |
Dizziness, loss of voice, swollen tongue & back of throat, difficulty swallowing, extreme headache, ...
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Dizziness, loss of voice, swollen tongue & back of throat, difficulty swallowing, extreme headache, & extreme neck ache. EMT's on site gave me a shot of 50 mg of Benadryl in my right arm. Halted the symptoms from getting worse, but symptoms did not clear until 24-48 hrs later.
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| 72 | 2021-02-08 | difficulty swallowing |
On 2/8/2021, 72yr old female with depressive disorder, GAD, HTN, hyperlipidemia, osteopenia was admi...
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On 2/8/2021, 72yr old female with depressive disorder, GAD, HTN, hyperlipidemia, osteopenia was administered COVID-19 Pfizer vaccine 0.3mL in right deltoid (LOT # EM9810). Patient has several documented allergies including meperidine (hallucinations), oxycodone (hallucinations), clonazepam (hives) and prednisolone (itching). Patient initially tolerated injection without incident and was sent for post-injection 15min observation. During 15min observation period, patient developed "difficulty swallowing". Patient brought back to room to be seen by provider. Patient noted issue was "mild" and denied any difficulty breathing. Patient able to talk in complete sentences without any evidence of wheezing or stridor.
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| 72 | 2021-02-08 | nausea |
02/04 - chills and headache all day; 02/05 - headache, fatigue, nausea; 02/06 - headache (partial da...
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02/04 - chills and headache all day; 02/05 - headache, fatigue, nausea; 02/06 - headache (partial day), nausea (am); fatigue all day; 02/07 - minor fatigue most of day
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| 72 | 2021-02-09 | nausea, vomiting |
Pfizer-BioNTech COVID-19 Vaccine EUA tiredness, headache, chills, nausea, vomit, feeling unwell, di...
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Pfizer-BioNTech COVID-19 Vaccine EUA tiredness, headache, chills, nausea, vomit, feeling unwell, dizziness and weakness
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| 72 | 2021-02-09 | vomiting |
Fever; Headache; Vomiting; This is a spontaneous report from a non-contactable consumer, the patient...
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Fever; Headache; Vomiting; This is a spontaneous report from a non-contactable consumer, the patient. This 72-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: Unknown), via an unspecified route of administration on 15Jan2021 (at the age of 72-years-old) as a single dose for COVID-19 vaccination. The patient's medical history was not reported. There were no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. On 20Jan2021, the patient experienced fever, headache and vomiting 5 days after vaccination. No therapeutic measures were taken as a result of the events. The clinical outcomes of the fever, headache and vomiting were resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 72 | 2021-02-10 | diarrhea, decreased appetite | Achy, muscle soreness, fatigue, lack of appetite, diarreha |
| 72 | 2021-02-10 | nausea, diarrhea |
2:00 am seizure, dizzy, weak, diarrhea, nausea, head pain, rapid heart beat. This got better. 3:30 a...
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2:00 am seizure, dizzy, weak, diarrhea, nausea, head pain, rapid heart beat. This got better. 3:30 am bad seizure with foaming at nose and mouth, convulsions, dizzy, unable to move, terrible head pain, nausea, rapid heart beat, extreme hot and cold spells; freezing from bones out. The seizure got bettter after about an hour, but the tremors did not stop until around 6:00 am.The morning of the shot, I ate a banana for breakfast. Only thing I ate after the shot was late lunch was rice with tomatos in it, green beans, fried squash (all out of my garden).
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| 72 | 2021-02-10 | nausea, vomiting |
Nausea, Vomiting, fever, chills, body aches, severe headache. (49) hours Fatigue, headache , lighth...
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Nausea, Vomiting, fever, chills, body aches, severe headache. (49) hours Fatigue, headache , lightheaded continue
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| 72 | 2021-02-10 | nausea |
Injection site pain, tiredness, headache, joint pain, swelling, redness, feeling unwell, fast heart ...
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Injection site pain, tiredness, headache, joint pain, swelling, redness, feeling unwell, fast heart beat, dizziness and weakness. nausea.
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| 72 | 2021-02-10 | nausea |
got real sick; fever; Nauseous; chills and was freezing to death; chills and was freezing to death; ...
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got real sick; fever; Nauseous; chills and was freezing to death; chills and was freezing to death; her hands and feet were cold; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on her left arm, via an unspecified route of administration on 25Jan2021 12:00 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that while on the way home, the patient got real sick, she had a 102 fever, had chills and was freezing to death, and was nauseous. She is feeling a lot better than she did earlier. The husband put a heating pad on her feet, her hands were cold, she had chills, she was cold all over, when you touched her, her hands and feet were cold. The first time he checked, her temperature when she was first home was 101.7, then went up to 102, and stayed there for a while, but she feels like it came down. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 72 | 2021-02-11 | diarrhea | diarrhea |
| 72 | 2021-02-14 | abdominal pain, diarrhea |
6 days after the first vaccine taken diarrhea started with abdominal pain each morning and lasted ab...
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6 days after the first vaccine taken diarrhea started with abdominal pain each morning and lasted about 6 hours. Pain and diarrhea subsided for that day. Next morning, the pattern started over and this lasted for 6 days in a row.
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| 72 | 2021-02-14 | vomiting, nausea |
Most Severe: Day 3 or 52.5 hours after second dose had sever and immobilizing nausea. Could not be v...
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Most Severe: Day 3 or 52.5 hours after second dose had sever and immobilizing nausea. Could not be vertical. Vomited. This lasted 3 hrs+/-. Less severe: starting approx 9 hrs after shot I experienced intermittent tingling in right arm (had shot in left arm) as well as right bicep muscle soreness. This lasted through day 4.
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| 72 | 2021-02-15 | nausea | Fatigue, chills, fever 102-104.2, nausea |
| 72 | 2021-02-16 | nausea |
SOB, sweating, dizziness, itching. After the 2nd dose of vaccine I had itching in arms and neck . Th...
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SOB, sweating, dizziness, itching. After the 2nd dose of vaccine I had itching in arms and neck . This was followed by dizziness, high BP, SOB, and nausea. The 2nd shot triggered post itching my neurocardiogenic syncope.
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| 72 | 2021-02-16 | nausea |
I woke up feeling ill with chills and slight fever. Overall tired and a bit nauseous. Body feels hea...
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I woke up feeling ill with chills and slight fever. Overall tired and a bit nauseous. Body feels heavy.
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| 72 | 2021-02-18 | nausea, decreased appetite |
Symptoms began within approximately 12 hours of vaccination with body aches and soreness, weakness a...
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Symptoms began within approximately 12 hours of vaccination with body aches and soreness, weakness and malaise, mental fogginess, chills and sweats, loss of appetite, slight nausea, needed assistance to walk. Symptoms subsided after two days, therefore did not seek medical attention.
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| 72 | 2021-02-18 | vomiting |
Received Pfizer vaccine #1 on 01/22/21 and seven days after developed severe vertigo and vomiting. ...
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Received Pfizer vaccine #1 on 01/22/21 and seven days after developed severe vertigo and vomiting. Received Pfizer vaccine #2 on 2/12/21 and 3 days later developed severe Vertigo and Vomiting.
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| 72 | 2021-02-21 | nausea |
the swelling of my face and throat; the swelling of my face and throat; injection site pain; tiredne...
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the swelling of my face and throat; the swelling of my face and throat; injection site pain; tiredness; headache; Muscle pain; joint pain/joint pain in her knees; hot flashes to where she would nearly pass out a couple of times; hot flashes to where she would nearly pass out a couple of times; nausea; face and everything was red; Dizzy; weak; chills; Feeling unwell; I had difficulty breathing; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9261) on her right arm, via an unspecified route of administration on 26Jan2021 15:30 at SINGLE DOSE for covid-19 immunization. Medical history included multiple myeloma, Kidney failure, dialysis; all on Aug2020 and ongoing and cancer. The patient's concomitant medications were not reported. The patient previously took an unspecified flu shot for swine flu but had a terrible reaction (allergies). It was reported by the patient had injection site pain in her right arm the next day after vaccination. Stated that she had tiredness, headache, muscle pain, joint pain in knees, hot flashes to where she would nearly pass out a couple of times, nausea that was very bad for two days. Stated that her face and everything was red, dizzy and weak and had chills. Stated that it has been eight days since she can do that. Stated that she took Extra Strength Tylenol for headache. The patient also stated that she was feeling unwell, that started on the 27th until today. She also had difficulty breathing that has lasted 8 days, the swelling of her face and throat on the 31Jan2021 for one day. The outcome of the event tiredness was recovering, unknown for events chills, feeling unwell, difficulty breathing and swelling face, while recovered for the other events.
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| 72 | 2021-02-21 | stomatitis |
Patient received Pfizer Covid vaccine # 1 02/05/2021. She developed the bumps on scalp (15 raised no...
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Patient received Pfizer Covid vaccine # 1 02/05/2021. She developed the bumps on scalp (15 raised nodules and sores around her mouth). She states the bumps wer not itchy and were no where else but on scalp. The sores around mouth were non vessicular. She did not present until 02/13/2021 and had taken steroids at home as she has so many reactions. 1 day she took 20 mg and the next 10 mg. several days later another 10 mg pill. On 02/13/2021 the scalp bumps not the lip sores were non visible. The was 1 raised area on the side of left face that appeared to be a stuck on lesion. She states the steroids took car of the rest. She was instructed to follow up with PCP and Dr to see if she should take second vaccine. Er for any s/s of distress. I dod not give her any additional therapy as the symptoms had abated.
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| 72 | 2021-02-22 | diarrhea |
delirium, diarrhea On 02/13/2021 pt entered physician office for incorrect appt date and found to d...
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delirium, diarrhea On 02/13/2021 pt entered physician office for incorrect appt date and found to disoriented. Transferred to Hospital. Pt had in-pt stay until 02/13/2021. Pt discharged to son's care as she was unable to care for herself indepently. As of 02/23/2021 pt has still not returned to baseline.
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| 72 | 2021-02-22 | nausea, diarrhea |
angina; angina; Fever; Chills; Cough; Sore throat; runny nose; Nausea; Diarrhea; Headache; arm heavy...
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angina; angina; Fever; Chills; Cough; Sore throat; runny nose; Nausea; Diarrhea; Headache; arm heavy; muscle aches and heaviness; muscle aches and heaviness; she just woke up feeling sick; fevers may come like a hot flash; This is a spontaneous report from a contactable healthcare professional (HCP) (patient). A 72-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Unknown), via an unspecified route of administration on 23Jan2021 at a single dose, in left arm for COVID-19 immunization. Medical history included fibromyalgia diagnosed years ago, angina (some stents). There were no concomitant medications. On Jan2021, the patient experienced angina, fever, chills, cough, sore throat, runny nose, nausea, diarrhea, headache, arm heavy, muscle aches and heaviness, and she just woke up feeling sick. The patient experienced multiple AEs after 1st dose of vaccine (received on 23Jan2021). The patient experienced angina later last week. Clinical course: The patient has misplaced card, states her second appointment for the second dose is this Saturday. Caller stated she started having these experiences the day after she was vaccinated with her first dose, received first dose of 23Jan2021. She had fevers, chills, cough- not an aggressive cough, a funny kind of sore throat- like something wrapped around her throat like the muscles of her throat, no congestion but does have a runny nose, states she has some nausea, no vomiting but feeling like she needed to vomit and diarrhea, and headache. The symptoms started about the third day after the vaccine, started with the fevers, stated the fevers may come like a hot flash, lasts seconds even, states you know it is a fever because your bones get hot. These symptom's did not attack her body at one time. Her whole arm stayed heavy, the whole arm not just the injection site, for almost 10 whole days. She previously had fibromyalgia and thought maybe that made the symptoms worse. She had muscle aches and feeling heavy. Her symptoms were spread out over time, no two were at the same time, sore throat was one of the last things. Diarrhea was ongoing, not a runny diarrhea but it was enough to empty stomach and was soft. She was a medic in the military, worked as a Nurse, clarifies she was an LPN and took all the underlying courses to be a PA. One of the issues she found, she thought it may be deadly, as a prior healthcare person and in tune to her body, the people who are in the nursing homes may not be mobile, states so one of the things she felt was just feeling really really sick, that she couldn't put a pin point on it, states she just woke up feeling sick, states she had the urge to get out of bed and got up and after she got up the feeling left her, states a person in the nursing home may just feel really bad and cannot get up, thinks a protocol should be that the people that are immobile should be required to move or if they can't get up they need to move their muscles, people with these symptoms need to get up and get moving. She also has history of angina and a stent, has not had angina in a while and had 3 days where she thought she may need to go talk to her doctor. It was on Wednesday, Thursday and Friday this week. States one of her friends, 92 years old, said she got high after the vaccine and didn't want to talk to anybody, states it was her first dose, she was kind of leery about the 2nd shot, feels like this was kind of aggressive. She had both doses and had no symptoms, but 92-year-old female had no symptoms right away, other than normal body aches and pains, but the next day was high as a kite. Her son has heart disease and she advised him not to take it right now. They were losing a lot of people to the vaccine in nursing homes, no further information provided. This could be affecting good hearts more than damaged hearts, read that this virus likes to work in parts of the body that are already damaged. The outcome of event diarrhea was not recovered, outcome of the other events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, a causal association between the reported angina and BNT162B2 cannot be completely excluded. Note however, that the patient has underlying angina with some stents that may also have contributed to the event. Case will be re-assess once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 72 | 2021-02-23 | abdominal discomfort, decreased appetite |
My arm was sore that night and it's still very sore today. Because of my leukemia I have enlarged ly...
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My arm was sore that night and it's still very sore today. Because of my leukemia I have enlarged lymph nodes and the lymph nodes under my arm has been very, very sore. I've had fevers, chills and fatigue. My stomach has been upset since the vaccine and my appetite has been decreased.
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| 72 | 2021-02-23 | nausea |
Extremely sore arm. Pulsing pain Breathing more labored. Brain fog Nausea Extreme Fatigue. F...
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Extremely sore arm. Pulsing pain Breathing more labored. Brain fog Nausea Extreme Fatigue. For two days
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| 72 | 2021-02-23 | nausea |
About 9:30 arm began to get sore(expected) about 11:00 started with a headache, then chills, fever, ...
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About 9:30 arm began to get sore(expected) about 11:00 started with a headache, then chills, fever, achy from head to toe but mostly back and sides, nauseous, lethargic and couldn't sleep
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| 72 | 2021-02-23 | nausea | Elevated high pressure, nauseas, dizziness and strong headaches. Couldn't sleep well. |
| 72 | 2021-02-25 | diarrhea |
None for first injection. Second injection started with extreme chills, moved to headache, muscle ac...
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None for first injection. Second injection started with extreme chills, moved to headache, muscle ache, weakness. Lasted 24 hours, mitigated with Tylenol. 10 days later, still suffering intermittent fatigue, weakness, inflamed lymph node near left breast, diarrhea and muscle ache.
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| 72 | 2021-02-25 | nausea | Fever 5am through midnight Headache Nausea am Tired |
| 72 | 2021-02-26 | nausea, difficulty swallowing |
On Feb 26th - approximately 45 minutes after vaccination and departing site, symptoms began. Swelli...
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On Feb 26th - approximately 45 minutes after vaccination and departing site, symptoms began. Swelling tongue and throat. Wheezing and difficulty swallowing. Proceeded to ER and taken in at 2pm. Treated at ER with IV of Benadryl, Famotidine, MethlyPredeniSolone, Medrol with little effect. Then did Epipen at 2:40pm. Observed and discharged from ER at 4:50pm . On Feb 27th - skin hives, headache, nausea, chills and overall body pain. Taking Benadryl. Have Rx with 2 EPIPEN kit.
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| 72 | 2021-02-26 | nausea, vomiting |
Developed nausea and vomiting after her COVID vaccine earlier today. Associated with chills and trem...
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Developed nausea and vomiting after her COVID vaccine earlier today. Associated with chills and tremors. These improved 45 minutes ago. Poor PO intake. No abdominal pain. COVID, flu negative. Mild systemic vaccine reaction. Zofran given and rx. Advised patient to speak with her PCP before considering second COVID vaccine.
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| 72 | 2021-02-26 | nausea | Tiredness, headache, nausea |
| 72 | 2021-02-28 | diarrhea |
Passed out; Constant running nose; Cough; bad cough; Sore throat; Diarrhea; This is a spontaneous re...
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Passed out; Constant running nose; Cough; bad cough; Sore throat; Diarrhea; This is a spontaneous report from a contactable consumer. A 72-years-old female patient received the second of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL9267, Expiration Date May2021, via an unspecified route of administration on 08Feb2021 (at the age of 72 years old) as SINGLE DOSE in the left arm for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. Historical information included BNT162B2 dose 1 for COVID-19 vaccination.The patient developed the sore throat on 09Feb2021, Cough; bad cough on 10Feb2021, constant running nose on 11Feb2021. On 11Feb2021, the patient passed out in the bathroom floor, had an ambulance here. Patient still coughing a little, not as badly. The patient experienced diarrhea in Feb2021. Treatment for all events included cetirizine (ZYRTEC), Triamcinolone (NASACORT), pseudoephedrine (SUDAFED), dextromethorphan hydrobromide, guaifenesin, paracetamol, pseudoephedrine hydrochloride (DAYQUIL). Outcome of the events Passed out, Sore throat, Constant running nose, Diarrhea was unknown. Outcome of the events Cough; bad cough was not recovered
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| 72 | 2021-02-28 | nausea |
Trouble breathing; nausea; severe headache/excruciating headache; Feeling generally unwell to the po...
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Trouble breathing; nausea; severe headache/excruciating headache; Feeling generally unwell to the point I almost went to the emergency room/terribly unwell feeling; This is a spontaneous report from a contactable consumer (patient). A 72-years-old non-preganant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot EN5318, via an unspecified route of administration on 02Feb2021 15:45 (at the age of 72 years old) for COVID-19 vaccination, Unspecified other vaccine (Pfizer) on 02Feb2021, dose number in the left arm for an unspecified indication.Medical history included asthma from an unknown date and unknown if ongoing (asthma under control), pancreatitis chronic from an unknown date and unknown if ongoing (Occasional chronic pancreatitis), Blood pressure from an unknown date and unknown if ongoing, drug allergies from an unknown date and unknown if ongoing. Concomitant medication included Blood pressure medication. The patient previously took morphine and experienced allergies morphine and sulfa and experienced allergies sulfa. The patient received the vaccination at the hospital. On 02Feb2021, the patient felt as if she was having a heart attack. On 02Feb2021, the patient had trouble breathing, nausea, and severe headache. On 02Feb2021, the patient was felling generally unwell to the point she almost went to the emergency room. The excruciating headache and terribly unwell feeling has lasted well over 10 days. No treatment was received for the events. Outcome of the events was recovering. The patient did not have covid prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19.
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| 72 | 2021-02-28 | nausea |
One week after shot, on 2-27 21, I awoke with splitting headache, muscle pain in my neck, nausea, a ...
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One week after shot, on 2-27 21, I awoke with splitting headache, muscle pain in my neck, nausea, a few chills (they did not last long), felt horrible for about 5 hours. I threw up midway, and then just slept. Felt a little better around 2:00 pm, took Tylenol at 4:00pm and that helped a lot. Got out of bed at 5:00 pm. Was able to eat a little dinner at 6:00 pm. Went back to bed around 9:00. Felt better in Am -Sunday, Feb 28; not 100% though. Tired. Long nap. Better today, Mar. 1. -- just a little off - woozy.
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| 72 | 2021-02-28 | nausea |
fever, chills, muscle ache, headache, cough, nausea (mild), fatigue, sore arm, injection site pain o...
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fever, chills, muscle ache, headache, cough, nausea (mild), fatigue, sore arm, injection site pain onset 12 hours after receiving the vaccine ongoing at this point
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| 72 | 2021-03-01 | decreased appetite |
Not feeling very energetic; I did not feel good; Chills; Fever; Headache; Did not feel like eating m...
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Not feeling very energetic; I did not feel good; Chills; Fever; Headache; Did not feel like eating much; Achy; This 72- year-old female patient contactable consumer (reported for herself) received the BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (lot EL9265; expiration not provided), via an unspecified route of administration, on 28Jan2021 at 09:15 AM (at the age of 72-years-old) as a single dose for COVID-19 immunization. The facility where COVID-19 vaccine was administered was at a hospital. Medical history included: COVID in Mar2020 and was hospitalized for 10 days, hypertension, thyroid disorder, and flu shot. Concomitant medication included: Hydrochlorothiazide 12.5 mg, once a day for blood pressure and medication for thyroid reported as: "NP" 0.5gms. On 28Jan2021 later on after vaccine, she reported 9:15 pm that she did not feel good. She had chills, fever, headache, did not feel like eating much, was achy, and not feeling very energetic. During the night temperature was 101.4. At 8 in the morning, I started taking 2 Tylenol, 500 mg and it went lower but then it would come back up, so I take more. So, it never went over 101.8. now here we are on the Saturday morning and I am not feeling very energetic and I still have just a 99 temperature. Treatment included: Tylenol. The clinical outcome of the events I did not feel good, chills, fever, headache, did not feel like eating much, Not feeling very energetic, and Achy were unknown. No follow-up attempts are possible. No further information is expected.
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| 72 | 2021-03-02 | abdominal pain, diarrhea |
abdominal cramping; diarrhea; sore arm day of injection (dose 2); This is a spontaneous report from ...
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abdominal cramping; diarrhea; sore arm day of injection (dose 2); This is a spontaneous report from a non-contactable consumer (patient). A 72-years-old female patient (not pregnant) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19), via an unspecified route of administration at arm left on 16Feb2021 at single dose for COVID-19 immunisation. Medical history included cirrhosis unknown origin, autoimmune disease/unknown origin and no known allergies. Concomitant medication included sertraline hydrochloride (ZOLOFT), omeprazole. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The historical vaccine included 1st of BNT162B2 on 26Jan2021. The patient experienced sore arm day of injection (dose 2) on 16Feb2021, abdominal cramping/diarrhea post dose day 2 (17Feb2021) vax 2. No treatment was received for the adverse events. The events outcome was recovering. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious. Information on the lot/batch number has been requested.
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| 72 | 2021-03-02 | nausea |
Headache, fever, swollen arm at injection site burning, rash, muscle ache, overall discomfort. Rash ...
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Headache, fever, swollen arm at injection site burning, rash, muscle ache, overall discomfort. Rash appeared day after injection as well as burning. Day of injection tired, arm very sore, didn't sleep well followed by feeling really sick nausea, just a little, then fever started terrible headache continued until next evening. Now arm sore also realized I have neck pain yesterday and now, still have rash the burning has subsided
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| 72 | 2021-03-02 | vomiting | Throwing up, falling from weakness. |
| 72 | 2021-03-03 | abdominal discomfort |
2nd day I had extreme tiredness, chills, upset stomach, sore shoulder, bad headache. 3rd day same, ...
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2nd day I had extreme tiredness, chills, upset stomach, sore shoulder, bad headache. 3rd day same, with fever & brain fog, & felt very weak, & I had a swollen & sore lymph node under my arm. On day 6 my upper are (& underneath) turned red & swollen. I also had been suffering random itching. On day 8 I went ER, & was given steroid cream. That night most of my back turned red. I put the cream on & it was gone next day, but my arm stayed red & itching. All this has made me weaker, & My stomach hasn?t felt good.
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| 72 | 2021-03-03 | diarrhea, nausea, abdominal pain upper |
stomach cramps; massive diarrhea; nausea; headache; This is a spontaneous report from a contactable ...
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stomach cramps; massive diarrhea; nausea; headache; This is a spontaneous report from a contactable consumer (patient). This 72-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot EK9231) via an unspecified route of administration in the left arm on 22Jan2021 at 17:15 (at the age of 72-years-old) as a single dose for COVID-19 immunization. Medical history included anal cancer from 2009 and unknown if ongoing; and cancer Non-Hodgkin's lymph from 1993 and unknown if ongoing. The patient had no allergies to medications, foods or other products. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included sertraline 100 mg from an unknown date for an unknown indication; rosuvastatin 5 mg from an unknown date for an unknown indication and cetirizine hydrochloride (ZYRTEK) from an unknown date for an unknown indication. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported on the fifth day (27Jan2021) she had stomach cramps, massive diarrhea, nausea and headache and had to lay down; lasting from about 09:00 to 18:00. The events were reported as non-serious and did not require hospitalization. No treatment was provided for the events. The clinical outcomes of stomach cramps, massive diarrhea, nausea and headache were recovered on 27Jan2021 at 18:00. It was also reported the patient was not tested for COVID-19 since vaccination.
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| 72 | 2021-03-03 | vomiting, abdominal pain |
Vomitting; severe abdominal pain secondary to pancreatitis; severe abdominal pain secondary to pancr...
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Vomitting; severe abdominal pain secondary to pancreatitis; severe abdominal pain secondary to pancreatitis; This is a spontaneous report from a contactable Consumer (patient). A 72-years-old female patient (no pregnant) received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 19Feb2021 10:15 at single dose at right arm for covid-19 immunisation. No pregnant at time of vaccination. Medical history included Diabetes, three prior strokes, cardiac stent, Seafood and pollen allergy. Concomitant medication included paracetamol (TYLENOL) and unspecified medication. The patient experienced Vomitting, severe abdominal pain secondary to pancreatitis for nonalcoholic patient with no history of abdominal pain or gallstone on 19Feb2021 18:00, which lead to Emergency room/department or urgent care, Hospitalization. Hospitalization lasted 4 days. Therapeutic measures were taken as a result of events included unspecified therapy. The outcome of events was recovering. information on the lot/batch number has been requested.
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| 72 | 2021-03-03 | vomiting, nausea | severe vertigo, chills, nausea, vomiting |
| 72 | 2021-03-04 | diarrhea, vomiting |
Vomiting, diarrhea, headache and mild fever about 12 hours after vaccine and lasting for about 4 hou...
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Vomiting, diarrhea, headache and mild fever about 12 hours after vaccine and lasting for about 4 hours. After 4 hours weak for several hours.
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| 72 | 2021-03-04 | nausea, retching |
Patient states woke up at 4 AM 2/23/21, felt ill and weak, went to wake up husband, "went black" and...
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Patient states woke up at 4 AM 2/23/21, felt ill and weak, went to wake up husband, "went black" and then blacked out woke up laying on floor, couldn't move arms or legs, not sure if hit head, laid on floor close to 1 hour, difficulty getting back into bed, extreme nausea, dry heaves, weak, headache, dizzy, chills, dizzy x 1 week, dizzy 3/3/21, got into bed 6:30 PM, face flushed and reddened, called daughter who is nurse, daughter checked temperature and blood pressure, no fever, B/P 156/102 (normally 120/82), B/P came down to when retaken to 140/90), was "upset" at time of first B/P reading, causing elevation. Continues to have weakness and fatigue, headache comes and goes.
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| 72 | 2021-03-05 | diarrhea |
Tiredness, mild diarrhea ,mild headache, achy all over, chills, began late evening the day I receive...
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Tiredness, mild diarrhea ,mild headache, achy all over, chills, began late evening the day I received the shot. Continued through the next day and then on the morning of the second day felt fine after a restful night sleep. Mostly I felt punk and rested.
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| 72 | 2021-03-05 | nausea |
At 1040, patient reported feeling light-headed and nauseous. We assisted her to a wheelchair and too...
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At 1040, patient reported feeling light-headed and nauseous. We assisted her to a wheelchair and took her to a private area. We assisted her in to a recliner. VS at 1040 were BP 164/76, P 110, RR 22 and O2 97%. Denied breathing difficulties, itching, swelling, or HA. Had patient remove mask and gave her water to drink. Declined Benadryl. Second set of VS at 1100 were BP145/70, P 85, RR 16, and O2 99%. Patient reports she feels like the symptoms were related to hot flashes that she has been experiencing for a number of years. At 1115, patient reported she felt better. I walked with the patient to the exit where her husband picked her up to drive her home.
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| 72 | 2021-03-06 | nausea |
Heavy chest cough, fever, chills, body aches, slight nauseated feeling, problem sleeping,, got bette...
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Heavy chest cough, fever, chills, body aches, slight nauseated feeling, problem sleeping,, got better Saturday but then same symptoms returned Saturday night and continue today, joint pain, muscle pain
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| 72 | 2021-03-06 | vomiting | Chills, vomiting,headache |
| 72 | 2021-03-07 | nausea | headaches, nausea, complete body aches, |
| 72 | 2021-03-07 | vomiting, nausea |
1st vaccination on January 30 I had a very intense headache whole 24 hours until I could take a pain...
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1st vaccination on January 30 I had a very intense headache whole 24 hours until I could take a pain killer. 2nd vaccination on February 27 had a slight headache 1st day. THIRD day I had 3 straight days of EXTREME dizziness and nausea, throwing up a few times over the 3 days. Then on 8th day dizziness and nausea returned for a day (yesterday). I hope this does not continue off and on.
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| 72 | 2021-03-08 | diarrhea | Fever, chills, diarrhea, |
| 72 | 2021-03-08 | nausea |
Moderately severe dizziness and nausea; Moderately severe dizziness and nausea; This is a spontaneou...
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Moderately severe dizziness and nausea; Moderately severe dizziness and nausea; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration at left leg on 19Feb2021 14:00 at single dose for COVID-19 immunization. The patient had allergies to fermented, mold producing foods: cheese, mushrooms and yeast. The patient had other medical history including osteoporosis, hypothyroidism and asthma. The patient is not pregnant. No other vaccine in four weeks. Concomitant medications (medications in two weeks) included levothyroxine and liothirinine. The patient previously received the first dose of BNT162B2 on 20Jan2021 15:00 for COVID-19 immunization. On day four following the second vaccine, on 23Feb2021 10:00, the patient experienced moderately severe dizziness and nausea. She could not move or walk without feeling extremely nauseous and dizzy. There was no treatment for the events. The events were assessed as serious medically significant by reporter. The patient had no COVID prior vaccination and not COVID tested post vaccination. The patient was recovering from the events. Information on lot /batch number has been requested.
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| 72 | 2021-03-08 | vomiting |
Excessive Vomitting all sunday. Minor Soft Stool. (also ate a half a can of peanuts. Doctor contrib...
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Excessive Vomitting all sunday. Minor Soft Stool. (also ate a half a can of peanuts. Doctor contributes vomiting to the peanuts as I have been having stomach issues for about 2-3 months. Doctor thought it was a good idea to report it anyway.)
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| 72 | 2021-03-09 | abdominal distension |
On 2/26/2021, I had a soaking night sweat and a few other symptoms. After 72 hours, (3/1/2021) labi...
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On 2/26/2021, I had a soaking night sweat and a few other symptoms. After 72 hours, (3/1/2021) labile blood pressure rose; lymph nodes left neck, breast and spleen were enlarged and tender;pain/tenderness cont'd down left side lymph nodes. General ache and pressure across back (kidney area). After 2-3 days, lymph nodes on right side became tender. Labile blood pressure requires medication (generic norvasc) but still fluctuates. Pain in joints and slight "bloating" overall. Sinus mucosa completely dry (nasal). These symptoms continue as of 3/9/2021.
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| 72 | 2021-03-09 | diarrhea |
Diarrhea; This is a spontaneous report from a contactable consumer (the patient). A non-pregnant 72...
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Diarrhea; This is a spontaneous report from a contactable consumer (the patient). A non-pregnant 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, in the left arm on 02Feb2021 at 02:30 AM (at the age of 72-years) as a single dose for COVID-19 immunization. Medical history included carpal tunnel syndrome. (The patient stated she received the first dose of the vaccine a week ago. She was prescribed Methylprednisolone for her carpal tunnel problem. She stated its not due to COVID shot as she had it - carpel tunnel syndrome before. She wanted to know if there is any interaction with Methylprednisolone and COVID vaccine). The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included atenolol, cetirizine hydrochloride (CETRIZINE), pantoprazole, celecoxib (CELEXA) , vitamin b complex (VITAMIN B). The patient received other vaccines within four weeks prior to the vaccination, which included varicella zoster vaccine RGE (CHO) (SHINGRIX), dose 2 in the left arm as a single dose on 13Jan2021 for immunization. On 04Feb2021 at 10:00 AM the patient experienced diarrhea. No treatment was given. The clinical outcome of diarrhea was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information about lot number has been requested.
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| 72 | 2021-03-09 | nausea, vomiting |
After monitoring period post Pfizer COVID-19 vaccine, pt experienced nausea, vomiting and light head...
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After monitoring period post Pfizer COVID-19 vaccine, pt experienced nausea, vomiting and light headedness in bathroom. Pts BP `132/80 o Notifications made: 911/Ambulance - paramedics on site. o Medications Ordered/Given Per Protocol: NONE o Patient was transferred to: ER by EMS
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| 72 | 2021-03-09 | nausea | extreme fatigue, unable to stand alone, extreme pain in joints, weakness, nausea, glassy eyes |
| 72 | 2021-03-10 | diarrhea |
Head cold; Diarrhea; developed a kind of allergies like a scratchy throat; Congested; This is a spon...
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Head cold; Diarrhea; developed a kind of allergies like a scratchy throat; Congested; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9262), via an unspecified route of administration on 25Jan2021 (at the age of 72-years-old) as a single dose for COVID-19 immunization. The patient's medical history included 'thyroid' from an unspecified date and unknown if ongoing. Concomitant medications were not reported. On an unknown date, reported as all of the sudden, the patient experienced a kind of allergy like a scratchy throat and then I was congested, a bad head cold (started last week) and from last night I started to have diarrhea. The clinical outcome of head cold, diarrhea, scratchy throat and congested was unknown.
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| 72 | 2021-03-11 | abdominal pain upper, vomiting | 100.2 temp, body aches, headache, stomachache, vomiting. |
| 72 | 2021-03-11 | nausea |
muscle stiffness during morning walk, nausea while eating cereal, stood up and fainted some nausea w...
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muscle stiffness during morning walk, nausea while eating cereal, stood up and fainted some nausea while on floor for 2.5 hours sleeping three hours later
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| 72 | 2021-03-11 | nausea |
Covid vaccine was administered on March 3 without any reactions or side effects afterwards. On 3/8 ...
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Covid vaccine was administered on March 3 without any reactions or side effects afterwards. On 3/8 she underwent a left molar extraction. Afterwards she had persistent left-sided pain and was taking NSAIDs at the recommended doses. She was also having intermittent nausea. On 3/11 she developed a rash which appeared like erythema multiforme versus urticaria on her chest, back and extremities. She also had very minimal swelling of her upper and lower lip. She presented to the ED. No fever or leukocytosis. Noted to have AST of 10,133, ALT of 8717, T bili 2.2, ALP 143. PTT 17. We suspect NSAID induced drug injury and rash.
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| 72 | 2021-03-12 | abdominal discomfort |
Pfizer-BioNTech COVID-19 Vaccine EUA headache for one day muscle aches for 2 days upset stomach for ...
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Pfizer-BioNTech COVID-19 Vaccine EUA headache for one day muscle aches for 2 days upset stomach for 1-2 days
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| 72 | 2021-03-12 | diarrhea |
Redness in the shot given area (small red area -somewhat hard to the touch) acey body, low grade fev...
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Redness in the shot given area (small red area -somewhat hard to the touch) acey body, low grade fever, chills and diarrhea.
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| 72 | 2021-03-13 | nausea |
After first shot, pain in arm, up neck across back and into arms and fingers. Hives on the inside of...
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After first shot, pain in arm, up neck across back and into arms and fingers. Hives on the inside of upper thighs. After second shot, severe headache. I couldn't stand light for first 24 hours then continuing headache for 4 days. First 24 hours, pain in arms to fingers, neck, upperback, ache all over. Second and third day nausea.
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| 72 | 2021-03-14 | diarrhea, vomiting |
severe Brain fog still 5 days later dysfunctional; severe whole body muscle pain even my fingers hur...
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severe Brain fog still 5 days later dysfunctional; severe whole body muscle pain even my fingers hurt 48 hours; severe whole body muscle pain even my fingers hurt 48 hours; drooling woke me up soaked the pillows; headache worse in my life 48 hours; dropping things hands wouldn't work; vomiting; severe diarrhea still problematic; Chills/cold shaking so hard teeth chattered; Chills/cold shaking so hard teeth chattered; Chills/cold shaking so hard teeth chattered; Still can't function normally 5 days now after 2nd shot; Still stuck in the house to weak to leave; Cognitive dysfunction; could not drive; trouble speaking; pins and needles both arms and legs; ataxia; received second dose of bnt162b2 on 19Feb2021; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that the 72-year-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, brand: Pfizer) , via an unspecified route of administration on 19Feb2021 01:15 pm on left arm at single dose for covid-19 immunisation. Medical history included Known allergies: iodine dye X-rays from an unknown date and unknown if ongoing. The patient's concomitant medications were none. The patient previously took first dose of bnt162b2 (COVID 19, brand: Pfizer) on 22Jan2021 at arm at single dose for covid-19 immunization. The patient experienced cognitive dysfunction (cognitive disorder) (medically significant) on 19Feb2021 18:00 with outcome of not recovered, could not drive on 19Feb2021 18:00 with outcome of not recovered, trouble speaking on 19Feb2021 18:00 with outcome of not recovered, pins and needles both arms and legs on 19Feb2021 18:00 with outcome of not recovered, ataxia on 19Feb2021 18:00 with outcome of not recovered, severe brain fog still 5 days later dysfunctional on an unspecified date with outcome of not recovered, severe whole body muscle pain even my fingers hurt 48 hours on an unspecified date with outcome of not recovered, severe whole body muscle pain even my fingers hurt 48 hours on an unspecified date with outcome of not recovered, drooling woke me up soaked the pillows on an unspecified date with outcome of not recovered, headache worse in my life 48 hours on an unspecified date with outcome of not recovered, dropping things hands wouldn't work on an unspecified date with outcome of not recovered, vomiting on an unspecified date with outcome of not recovered, severe diarrhea still problematic on an unspecified date with outcome of not recovered, chills/cold shaking so hard teeth chattered on an unspecified date with outcome of not recovered, still can't function normally 5 days now after 2nd shot on an unspecified date with outcome of not recovered , still stuck in the house to weak to leave on an unspecified date with outcome of not recovered. No treatment received. She is not pregnant. Facility type vaccine was hospital. No other vaccine in four weeks. The patient reported that "Cognitive dysfunction, could not drive, trouble speaking, pins and needles both arms and legs, ataxia, stumbling. 72 hours of ataxia severe Brain fog still 5 days later dysfunctional severe whole body muscle pain even my fingers hurt 48 hours drooling woke me up soaked the pillows , headache worse in my life 48 hours dropping things hands wouldn't work vomiting and severe diarrhea still problematic Chills/cold shaking so hard teeth chattered Still can't function normally 5 days now after 2nd shot Still stuck in the house to weak to leave , still ataxic." No COVID prior vaccination. No COVID tested post vaccination. Information about Lot/Batch number is requested.
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| 72 | 2021-03-14 | nausea, indigestion |
03.11.21 Thursday Day 1: Arm sore and swollen by bedtime, c. 2:00 am Friday. 03.12.21 Friday ...
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03.11.21 Thursday Day 1: Arm sore and swollen by bedtime, c. 2:00 am Friday. 03.12.21 Friday Day 2: Arm remains sore and more swollen than yesterday. Mild nausea all day. Moderate ?acidity? all day. Mild muscle aches all day but now seem to be lessening (8:43 pm). Started feeling unusually tired around 6 pm. 03.13.21 Saturday Day 3: Arm sore at vaccine site only. Nausea stronger. Acidity stronger ? feels like undilute sulfuric acid is burning a hole in my stomach. Extremely unpleasant. Less fatigued than yesterday. Very mild muscle aches. 03.14.21 Sunday Day 4: Nausea mild. Acidity mild. Unpleasant. More energy than any day since vaccine. 03.15.21 Monday Day 5: Very mild nausea and acidity, but still unpleasant. Slept too late but good energy level otherwise.
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| 72 | 2021-03-14 | nausea |
Nausea. Fatigue, pressure back of head, dizzy, jittery, sleeplessness, hot feeling top portion if...
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Nausea. Fatigue, pressure back of head, dizzy, jittery, sleeplessness, hot feeling top portion if stomach.
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| 72 | 2021-03-14 | retching | night chills, sweating, dry heaves, weakness, tiredeness |
| 72 | 2021-03-14 | vomiting |
I had chills for 2 hours. headache. fever of 101.6. vomiting all over the place. I couldn't even dri...
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I had chills for 2 hours. headache. fever of 101.6. vomiting all over the place. I couldn't even drink a sip of water. cramps. leg pain. pain inbetween my shoulders. I could barely stand up, I was very weak. I went to the hospital and got a few shots to help with the vomiting. (Finigan) and medicine for the cramps and muscle aches. Fatigue and headache still lingers.
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| 72 | 2021-03-15 | diarrhea, vomiting |
After both shots I experienced severe vomiting, diarrhea for several hours. My second shot was on Ma...
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After both shots I experienced severe vomiting, diarrhea for several hours. My second shot was on March 5. 3 weeks after the first shot on Feb.3 (taken to hospital emergency room by ambulance ) and One week after my second shot on March 5, I experienced severe vomiting and diarrhea which I treated at home.
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| 72 | 2021-03-15 | nausea | Fever 101.9, headache, nausea, burning sensation in spine, chills |
| 72 | 2021-03-15 | retching, nausea |
I am reporting the below as everything written has NEVER happened to me before in my 72 years of liv...
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I am reporting the below as everything written has NEVER happened to me before in my 72 years of living. This has all taken place since I have had the Vaccine Injection on Wednesday, February 24th. I am attributing all of this as a possible reaction to the vaccine or maybe coincidence. I wanted to report what has taken place so you all can assess if this is a possible adverse reaction, a direct effect from the vaccine or just coincidence. Please let me know if anything like this has been reported and what your thoughts about the matter. Wednesday, February 24th 11:15am Pfizer Vaccine right arm ?about an hour later discomfort on shot side that went from the shoulder up the right side of the neck. Was gone by next day. Thursday, February 25th Day seemed to be normal. When I went to bed that evening a pressure and pounding on the left top side of the head, on the part line. Lasted 5-6 hours and then went away for that episode. Friday, February 26th Day started off OK, walked 2 miles and then ran some errands. *3:00pm I bent down to pick up something and when I came up I had extreme light headedness like I have never had before. I was able to get myself collected and then continued to get ready to go out. *6:00pm I just sat in a chair in the restaurant and BAM the room started spinning at about 500 miles (that is the speed that it felt like) an hour. My arms were flailing as I was trying to grab something to old onto. Just when I was about to fall off of the chair my husband walked up and grabbed me as he could see that something was going on and he said that I was white as a sheet. Once I got somewhat collected, I knew immediately that I had to throw up. My husband took me to the restroom. I had severe dry heaves that just would not stop. I wasn?t breathing properly so my hands and feet were numb, tingly and very white in color. Then I had to have a bowel movement. We phoned for the ambulance to take me to the hospital jus to make sure that I did not have a stroke, or it was my heart, or a vessel had burst in the head. The Paramedic tested me for a stroke and I passed the test. *8:00pm or so I had another episode with room going around at top speed and I started having dry heaves. Nurse gave me medicine in the IV for nausea. My Doctor said that everything was Benign. He said that the CT patient scan was negative and all other tests were OK. Saturday, February 27th I was released from the hospital and went home. I did very little that day. I slept that night from 10:00pm until 10:00am the next day. Sunday, February 28th I was lightheaded, had a headache, and ears ringing all day. I just did not feel myself at all. Tuesday, March 9th Around noon I had a severe lightheadedness/spinning episode, eyes felt like they were spinning. Laid down for about 2 hours and when I got up I was able to function and the spinning had gotten better. Headache all night long, ears ringing, feeling of lightheadedness. Wednesday, March 10th Not quite as dizzy, headache all day, back of neck and left side of head sore to touch. Pounding on left top side of head ? along the part line, where I had the same discomfort the 2nd day after the vaccine. Thursday, March 11th Having discomfort on left side of head. To the right of the left ear, going down to the neck. I can touch those areas and add to the discomfort. Friday, March 12th On Monday, March 7th I noticed a red spot on the right side behind where I was given the injection. I tried to treat it myself but my remedies were not helping. Contacted my Dermatologist on Thursday, March 11th. She saw me today, Friday, March 12th. She is not sure if it is a possible aftermath of the vaccine or something else. Had some bloodwork run to rule how Shingles. Prescribed some medication for Shingles to take until Monday when the bloodwork report is due for review. Blood work was negative for Shingles. Ever since the episode on February 26th I have NOT felt myself at all. Lightheaded, nausea, headache, pressure in head and feels heavy, not steady on my feet, discomfort in back of head near neckline, on/off discomfort in the top of the head with a pounding force. BLOOD PRESSURE IS NOW HIGHER THAN NORMAL ESPECIALLY WITH BOTTOM NUMBER BEING HIGH. I have never had a Blood Pressure problem, although as I have aged the top number has elevated but not enough to take medicine. However, the lower number is now elevated (high 80-?s, low mid range 90?s) and Cardiologist is going to make a decision on whether I should start on a low dose medicine. I am to take my 2nd Pfizer shot tomorrow ? Wednesday, March 17th at 11:00am. Thank You for reviewing the above writings. I look forward to the conclusion VAERS makes on my situation.
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| 72 | 2021-03-16 | decreased appetite |
Within 72 hours fevers, body aches, myalgia, exhaustion, poor appetite. Sx resolved after 7-10 day...
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Within 72 hours fevers, body aches, myalgia, exhaustion, poor appetite. Sx resolved after 7-10 days.
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| 72 | 2021-03-16 | diarrhea, nausea |
Afib,5hours in length on Tues March 10th BP at 176/89 on Wed at home and Thurs at Dr's office Ongoi...
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Afib,5hours in length on Tues March 10th BP at 176/89 on Wed at home and Thurs at Dr's office Ongoing in up and down cycles: chills,tight chest,foggy brain,bronchial cough with thick mucous ,some green, intense sneezing, nausea,diarrhea, Today,Wed March 17th very slow brain function low fever,diarrhea,very tired,hard to focus, less sneezing,no green mucous in cough.
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| 72 | 2021-03-17 | nausea |
Arm started to hurt at injection site in the evening , then feeling somewhat achy & headachy. Progr...
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Arm started to hurt at injection site in the evening , then feeling somewhat achy & headachy. Progressed to chills, body aches, fever, joint pain, and minor nausea through a good part of the night. This morning I still feel headachy and have a low fever. Have not taken any pain reducers.
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| 72 | 2021-03-17 | nausea |
The morning following first dose I woke up with a headache, body aches, slight fever, dizzy & nausea...
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The morning following first dose I woke up with a headache, body aches, slight fever, dizzy & nausea. These went on for the next week. I didn't go into work February 26th. But did go in partial days all the next week. Very uncomfortable. The headache got worse each day until it was very bad. On March 10th I woke up with my left arm in excruciating pain and the headache. Went to urgent care and doctor gave me a shot of Tromodol. When I got to the parking lot, I became very dizzy and my legs gave out and fell in the parking lot down to t he ground. Went to ER and waited for about 3.5 hours and left and went home. Went back to ER on March 12th due to arm in constant pain. Not able to sleep or relax. Wait this time was 3 hours and I was in too much paid so my daughter took me around the corner to urgent care. I was given steroid, muscle relaxer and a cream for my arm. My left arm from muscle up to shoulder and into wrist continues to hut. Today is 3/18/2021.
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| 72 | 2021-03-17 | nausea |
Just lots of symptoms for 48 hours after: injection site pain, tiredness, headache, muscle aches, ch...
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Just lots of symptoms for 48 hours after: injection site pain, tiredness, headache, muscle aches, chills, nausea, feeling unwell, feeling hot (but no actual temperature). I did NOT have a severe allergic reaction, just
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| 72 | 2021-03-18 | decreased appetite, diarrhea |
RA; no energy/weak; OA; coughing; chilling; diarrhea; headache; we are not hungry but food is tastel...
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RA; no energy/weak; OA; coughing; chilling; diarrhea; headache; we are not hungry but food is tasteless/no taste; fibro; no taste/food was tasteless; She did not feel very well; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for her husband and herself. This is the first of two reports for herself. Only this case is serious. A 72-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot # EN6201, via an unspecified route of administration on 10Feb2021 17:15 as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included unspecified products in two weeks. There was no other vaccine in four weeks.The patient experienced coughing, weak, no taste, chilling, diarrhea, no energy, headache all on 11Feb2021. She did not feel very well on the day she took her shot on 10Feb2021 but did not have a fever. She was not hungry but food was tasteless.It was also reported that "she had RA OA and fibro. and take thyroid medicine besides medicine for the others. Adverse event start date: 11Feb2021". No treatment was received for all events and events outcome was not resolved.The patient did not have COVID prior vaccination and no COVID tested post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021207100 same reporter/product, similar events, different patient
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| 72 | 2021-03-18 | decreased appetite, nausea |
Fever of 3 degrees; extreme fatigue; nausea; dizziness; loss of appetite; loss of smell/taste; loss ...
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Fever of 3 degrees; extreme fatigue; nausea; dizziness; loss of appetite; loss of smell/taste; loss of smell/taste; sore throat; This is a spontaneous report from a contactable consumer. A 72-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the right arm on 06Feb2021 (Batch/Lot number was not reported) at 72-years-old as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine. The patient did have COVID prior to the vaccination. Medical history included penicillin allergy, Brazil nuts allergy, COVID-19 (recovered from COVID 11 days prior); all from an unknown date and unknown if ongoing. Concomitant medications included simvastatin (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; citalopram (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; famotidine (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported. On 07Feb2021 at 04:00, the patient experienced fever of 3 degrees (non-serious), extreme fatigue (non-serious), nausea (non-serious), dizziness (non-serious), loss of appetite (non-serious), loss of smell/taste (non-serious), sore throat (non-serious); which the patient described as "like a mini COVID storm." There was no treatment received due to the events. The patient underwent lab tests and procedures which included body temperature: 3 degrees on 07Feb2021. The clinical outcome of the events was recovered in Feb2021. The patient was not tested for COVID post vaccination. The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
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| 72 | 2021-03-18 | decreased appetite |
head ache chills fatigue loss of appetite pain at location of injection gradually t spread to overal...
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head ache chills fatigue loss of appetite pain at location of injection gradually t spread to overall pain dizzy symptoms are resolving still noticing dizziness by day 2
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| 72 | 2021-03-18 | vomiting, nausea |
Patient received first dose of Pfizer COVID vaccine on 2/24/21 (lot # EN6198). Patient reported diz...
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Patient received first dose of Pfizer COVID vaccine on 2/24/21 (lot # EN6198). Patient reported dizziness/lightheadedness and nausea/vomiting after receiving the vaccines. No other detail was noted in patient?s MAR.
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| 72 | 2021-03-19 | retching |
Within a few minutes, felt faint, unwell, did faint, came to, hot and sweaty, retching, heartbeat 11...
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Within a few minutes, felt faint, unwell, did faint, came to, hot and sweaty, retching, heartbeat 110.
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| 72 | 2021-03-20 | nausea |
72 yo F with cardiac history presented with nausea after vaccine administered. No vomiting. Endorsed...
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72 yo F with cardiac history presented with nausea after vaccine administered. No vomiting. Endorsed skipping dose of Lasix today because she did not want to have to urinate so frequently at vaccination site today. Denies any chest pain, states she had chronic SOB, which is her baseline, no changes. NO additional symptoms. HR 70, BP 115/65, 96% on RA. Symptoms resolved spontaneously. DIscharged home after 30 minute obs, but advised to go ER should symptoms recur and/or worsen.
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| 72 | 2021-03-20 | retching, nausea |
Dry heaves, nausea, headaches, back pain. Started with dry heaves & headache on the 6th of March. ...
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Dry heaves, nausea, headaches, back pain. Started with dry heaves & headache on the 6th of March. Continued with both and added intermittent nausea. Began to have back pain during the 1st week. Unable to eat more than 1-2 bites with nausea. Took OTC pain medications. Tele-health call to PCP on 3/16/21 and obtained prescription for Zofran, which help a little. Eventually, symptoms started to subside the week of 3/24/21.
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| 72 | 2021-03-21 | nausea | Headache, body aches, arm pain injection site, tiredness, nausea |
| 72 | 2021-03-21 | vomiting, nausea | Severe headache, nausea, vomiting, muscle and joint pain, weakness, fatigue and chills |
| 72 | 2021-03-22 | nausea, decreased appetite |
Shaking, joint pain, fever of 101, loss of appetite, headache, tiredness, nausea, pain and redness a...
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Shaking, joint pain, fever of 101, loss of appetite, headache, tiredness, nausea, pain and redness at injection site. These symptoms persisted for 48 hours.
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| 72 | 2021-03-22 | nausea | Fever, severe chills, aches, nausea |
| 72 | 2021-03-22 | vomiting |
Pt recieved 1st Pfizer vaccine on 2/25/21 and her 2nd one on 3/18/21 Pt went to the ER on 3/23 via 9...
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Pt recieved 1st Pfizer vaccine on 2/25/21 and her 2nd one on 3/18/21 Pt went to the ER on 3/23 via 911 in full cardiac arrest Per daugher, she c/o lightheaded this A< she came out of her room snad fell down, was vomitting and labored breathing paramedics were called, she went to Hospital and later died
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| 72 | 2021-03-23 | abdominal pain upper, vomiting | Sudden onset of severe stomach pain with vomiting, |
| 72 | 2021-03-23 | nausea | Nauseous, headache, sweating |
| 72 | 2021-03-25 | abdominal discomfort, decreased appetite, diarrhea |
Within a couple of days of vaccination, I developed diarrhea. I felt like my stomach was a little up...
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Within a couple of days of vaccination, I developed diarrhea. I felt like my stomach was a little upset and I didn?t have much appetite. My doctor advised I take over the counter stomach medication. I took some Mylanta and that helped. I can?t take Miralax because it upsets my stomach, and I heard the vaccine also has Polyethylene Glycol and I thought that may have been why I reacted with that. The diarrhea lasted ten days.
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| 72 | 2021-03-25 | indigestion |
After 1st shot had 8 days of a migraine and vertigo every day. Then after second shot 3 weeks later...
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After 1st shot had 8 days of a migraine and vertigo every day. Then after second shot 3 weeks later, had 11 out of 12 days of migraine and after 8.5 days after shot had a whole body rash for 4.5 days . I have had vertigo most every day since the last shot on 2/20 and have had 27 migraines since the 1st shot Jan 30th I used Hydrocortisone on the itchy, blistery rash. Not much sleep for 3 nights. The night before the rash popped out I experienced chest pain that I thought was heartburn but was not relieved with baking soda and water and charcoal pills. It didn't go away until the hours into the next day and the rash was there at 3am. I have had Migraines for many years but this is 4 times more migraines.
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| 72 | 2021-03-25 | nausea | Headache, extreme fatigue, muscle aches, nausea |
| 72 | 2021-03-26 | decreased appetite | Brain Fog, extreme fatigue affecting my balance, muscle aches, loss of appetite, chills, fever |
| 72 | 2021-03-27 | abdominal discomfort | Dizzy, muscular pain, fever, excessive sweating, upset stomach, feeling out of breath, fatigue |
| 72 | 2021-03-30 | abdominal pain |
had an anaphylactic reaction and acute hepatitis and was hospitalized for 5 days; had an anaphylacti...
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had an anaphylactic reaction and acute hepatitis and was hospitalized for 5 days; had an anaphylactic reaction and acute hepatitis and was hospitalized for 5 days; pain in abdomen and face/Abdominal pain; pain in abdomen and face; Generalized pruritus with skin rash; Respiratory distress; Angioedema (not hereditary); a lot of pain after her tooth extraction; Upper airway swelling; Cyanosis; Hoarse voice; Difficulty breathing; Sensation of throat closure; Generalized urticaria (hives); Generalized erythema; Generalized pruritus with skin rash; Localized injection site urticaria; This is a spontaneous report from a contactable nurse (patient). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 03Mar2021 15:00 (Lot Number: EN6199) (at the age of 72 years old) as single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD); osteoarthritis; rheumatoid arthritis (RA); allergy: Environmental; asthma. Concomitant medications included ubidecarenone (COQ10 [UBIDECARENONE]) ongoing; atorvastatin ongoing; nebivolol hydrochloride (BYSTOLIC) ongoing; methimazole ongoing. The patient was taking some medications prior to the event being reported. No prior vaccinations (within 4 weeks). The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than bnt162b2 prior to the event being reported. The patient had not received any other vaccines around the time of bnt162b2 vaccination. Caller would like to know if there was an impact on efficacy if she chooses to take her second dose of the Pfizer BioNTech COVID-19 vaccine at a later date than the recommended 21 days. Caller received her first dose of the Pfizer BioNTech COVID-19 vaccine on 03Mar2021. She stated that on 08Mar2021 she had a tooth extraction and was told by her physician to take Advil. Then on 11Mar2021 caller reported that she had an anaphylactic reaction and acute hepatitis and was hospitalized for 5 days. She stated that her physicians were unsure if it could have been a delayed reaction to the vaccine or a reaction to the Advil (which caller stated she had taken all her life) (lot number: 55633, Expiry Date: Feb2023). Caller was scheduled to receive her second dose of the vaccine next week and would like to know if she should take it. She stated one physician told her it was okay to do so while another told her to hold on taking it, so she was confused as to what to do. Reporter seriousness for Anaphylactic reaction was Hospitalization. The patient was in hospital for Anaphylactic reaction from 11Mar2021 to 14Mar2021. The patient stated she received her first COVID vaccine on 03Mar2021, and on 08Mar2021, she had a tooth extracted. Because of that, she was taking Advil on 11Mar2021, she had an anaphylactic reaction to the Advil and an acute hepatitis. And the doctors couldn't give her any answer. They didn't know what caused what and if it was a delayed reaction from the vaccine because it was one week following the vaccine or if it was just coincidental. The patient due next week (scheduled for 23Mar2021) for her second dose and wanted to know if she should she take it. She ended up in the hospital for five days. Date of hospitalization was 11Mar2021. Reason for hospitalization was Anaphylactic reaction. Date of discharge from the hospital was 14Mar2021 (pending clarification). Event "had an anaphylactic reaction and acute hepatitis and was hospitalized for 5 days" started from 11Mar2021 18:00. Seriousness Criteria: Hospitalization / Prolongation of hospital, hospitalized Duration of stay was 5d, event not recovered. The event required visit to Emergency Room. Treatment included steroids and fluids IV. "Tooth extraction" started from 08Mar2021 and treatment included Tylenol and Advil. Consumer stated she was still in a lot of pain after her tooth extraction (Mar2021). On 08Mar2021 she had a tooth extraction. After the procedure she had severe pain and she was taking Advil and by Thursday 11Mar2021 she had a lot of pain in abdomen and face. She went to ER 18:00 PM, she was going through a complete reaction. The patient required medical intervention: Corticosteroids, IV fluids. The patient was seen in the Emergency Department. The patient had hospitalized for 5 days. The patient was not admitted to an Intensive Care Unit. In Mar2021, the patient had Upper airway swelling, Respiratory distress, Cyanosis, Hoarse voice, Difficulty breathing (without wheeze or stridor), Sensation of throat closure, Generalized urticaria (hives), Generalized erythema, Angioedema (not hereditary), Generalized pruritus with skin rash, Localized injection site urticaria, Abdominal pain. No Bilateral wheeze/bronchospasm. No Stridor, No Increased use of accessory respiratory muscles, No Recession, no Grunting, no Dry cough, no Sneezing, No Rhinorrhea, No Shock, No Tachycardia, No Capillary refill time > 3 sec, No Decreased level of consciousness, No Loss of consciousness, No Generalized pruritus without skin rash, no Generalized prickle sensation, No Diarrhea, no Nausea, no Vomiting. Tachypnoea: Unknown. Measured hypotension: Unknown. Reduced central pulse volume: Unknown. The events did not require the initiation of new medication or other treatment or procedure. Lab work included Liver function over 10 000 in Mar2021. Patient's outcome following the potential anaphylactic reaction was Recovering. The outcome of the events "had an anaphylactic reaction and acute hepatitis and was hospitalized for 5 days", "a lot of pain after her tooth extraction" was not recovered, of "pain in abdomen and face" was unknown, of the other events was recovering.; Sender's Comments: Based on the temporal relationship, the association between the events anaphylactic reaction, hepatitis acute, and respiratory distress with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 72 | 2021-03-30 | nausea |
Headache; Nausea; localized, large red spot where she received the injection; This is a spontaneous ...
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Headache; Nausea; localized, large red spot where she received the injection; This is a spontaneous report from a contactable consumer. A 72-year-old female consumer(patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL9264, Expiration date: unknown) via an intramuscular route of administration in left arm on 28Jan2021 at 9:30 am as single dose for COVID-19 Immunization. The patient's medical history included Osteopenia(ongoing) diagnosed 20 years ago, patient had allergies with grasses, trees, and dust. The patient also allergic to penicillin and Succinylcholine, which is a muscle relaxer. The patient clarified she shouldn't say allergic, but more so hypersensitive. The patient reported that she took nothing but over-the-counter supplements. On 06Feb2021 patient experienced localized, large red spot where she received the injection, Headache and Nausea. The patient also stated that 9 days after vaccination she developed "COVID arm", she clarified it was a localized, large red spot where she had received the injection, she had no reaction or redness or anything else when she received the injection on 28Jan2021. After 9 days of vaccination, on 06Feb2021 (Saturday)the patient first noticed the spot at the injection site she also had a headache and nausea. She was actually awakened at 2am on 06Feb2021 by the headache. She did not notice the spot at the injection site at this time, but she wasn't looking for it. Caller didn't notice the spot until taking a shower. She confirms she recovered completely from the headache and nausea on 08Feb2021 and the spot was also gone. The patient did not require hospitalization. The outcome for the events was recovered on 08Feb2021. No follow-up attempts are possible. No further information is expected.
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| 72 | 2021-04-01 | nausea |
Pfizer-BioNTech COVID-19 Vaccine EUA 72 year old female healthy, not on any medications, came to hos...
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Pfizer-BioNTech COVID-19 Vaccine EUA 72 year old female healthy, not on any medications, came to hospital for her first covid vaccine. After approximately 10 minutes vaccination, she started feeling dizzy, light headed, slightly nauseated. Reports sweating and cold hand. Patient was taken to the emergency department and later admitted to the hospital with new onset afib/aflut with RVR following first dose of Pifzer Covid-19 vaccination. Further workup revealed reduced EF on ECHO and elevated LFTs. Patient was treated and discharged home.
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| 72 | 2021-04-17 | diarrhea |
faint; tired; chills; mild diarrhea; This is a spontaneous report from a contactable consumer (patie...
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faint; tired; chills; mild diarrhea; This is a spontaneous report from a contactable consumer (patient). This 72-year-old female patient received bnt162b2 dose 1 intramuscular in right arm on 13Feb2021 16:00 PM (Lot number unknown) at single dose for COVID-19 immunization. The patient had known allergies to penicillin and shellfish. Other medical history was not provided. The patient's concomitant medications included atorvastatin, vitamin, fish oil, probiotic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient became faint, tired and had chills which caused mild diarrhea from 13Feb2021 05:00 PM. The patient did not receive treatment for the event. Since the vaccination, the patient has not been tested for COVID-19. The patient received the bnt162b2 dose 2 intramuscular in Right arm on 06Mar2021 01:15 AM (Lot number unknown) at single dose for COVID-19 immunization. The outcome of the event events was recovered. Information on the lot/batch number has been requested.
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| 72 | 2021-04-17 | nausea |
hoped she wasn't having a heart attack; Elevated Pulse/high pulse/pulse was 165 beats per minute/cli...
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hoped she wasn't having a heart attack; Elevated Pulse/high pulse/pulse was 165 beats per minute/climbed up to 195; Drenched in sweat/sweating/sweating like a dog in the middle of the night; Wasn't feeling well; Tightness in chest; Cough; Sinuses congested; Sore; Puffy, bubbled up arms, inflamed; Puffy, bubbled up arms, inflamed; Feverish/felt hotter than usual; Really, really tired/wiped out tired; so sleepy; Sore Arm/her arm started to hurt; Nauseous; Sore Throat/throat hurts; eyes half closed/eyes closing; Puffy Face; blood clot; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8733, expiry date: unknown), via an unspecified route of administration, on 29Mar2021 11:45, as single dose, for COVID-19 immunisation. Medical history included ongoing latex allergy (developed welts where the straps met the skin) diagnosed 20-30 years ago; ongoing dye allergy (developed warm soreness to leg, tightness in the chest, could not breathe) diagnosed many years ago; sulphite allergy (diagnosed about 1975-1980; cannot eat processed foods, bleached foods, frozen pre-made foods; tries to eat only single item foods; last anaphylactic reaction after eating olive oil at a restaurant because it had sulphites in it; Mother was possibly allergic to sulphites; Son also allergic to sulphites); and blood pressure that runs low. The patient previously took epinephrine and experienced epinephrine allergy; ciprofloxacin (CIPRO) and experienced Cipro Allergy (eyes closed, got puffy, couldn't breathe); amoxicillin for abscessed tooth and had a reaction because of the sulphites in it; epinephrine (EPIPEN) and experienced epinephrine allergy (does not use it anymore); plantago ovata (METAMUCIL) which she then found out the orange one had sulphites. Historical vaccine included flu shot for immunization and she experienced 104-degree temperature and was sick as a dog and she went to the emergency room (she had flu shot maybe 3 times). Ongoing concomitant medication included multivitamins. The patient got her first dose of BNT162B2 on 29Mar2021 at 11:45. On the same day, once she got home, she became really, really tired/wiped out tired; was so sleepy; experienced sore arm/her arm started to hurt; was nauseous; had sore throat/throat hurt; eyes half closed/eyes closing and puffy face. On 30Mar2021, the patient experienced elevated pulse/her pulse got too high/pulse was 165 beats per minute/climbed up to 195. Her heart rate was 194 at some point for a couple of minutes then stayed at 165 for a long time. She hoped she wasn't having a heart attack. She had tightness in her chest, wasn't feeling good and was coughing. She stayed in her bed to wait out her symptoms. These lasted for 10 minutes (as reported). She started meditating hoping her heart rate would decrease and it did after about 15-20 minutes. The patient also felt feverish/felt hotter than usual. Before she took the vaccine on 29Mar2021, her temperature was at 96. She stated that her temperature usually runs low as 95-06 degrees. She also felt like her sinuses were congested; was sore; had puffy, bubbled up arms, inflamed. The patient hoped it was not a blood clot she developed. At the time of the report, the patient stated that her heart rate was 61 beats per minute, earlier it was in the 70s; and her temperature was at 96.3. Her second dose is scheduled on 19Apr2021 and mentioned that if these were her reactions with the first dose, she is questioning getting the second dose. The outcome of "blood clot", "hoped she wasn't having a heart attack", "Wasn't feeling well", "Tightness in chest", cough, and sinuses congested was unknown. The patient recovered from "Drenched in sweat/sweating/sweating like a dog in the middle of the night", and "Elevated Pulse/high pulse/pulse was 165 beats per minute/climbed up to 195" on 30Mar2021; and was recovering from "Sore Arm/her arm started to hurt", and "eyes half closed/eyes closing". The outcome of the remaining events was not recovered. Information on the lot/batch number has been obtained. Additional information is expected.
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| 72 | 2021-04-20 | retching, diarrhea |
Dry heaves; diarrhea; headache; ringing in her ears; dizziness; fever; chills/ shaking with chills; ...
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Dry heaves; diarrhea; headache; ringing in her ears; dizziness; fever; chills/ shaking with chills; sweats; Freezing; dehydrated; This is a spontaneous report from a contactable consumer who reported for herself. A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: ER8732, via an unspecified route of administration, administered in left arm on 25Mar2021 at 16:30 as single dose for COVID-19 immunisation. Medical history included ongoing osteoarthritis. She had severe osteoarthritis and took medication for the arthritis pain. She said she had been taking the osteoarthritis pain medication for a couple years. Concomitant medications were not reported. Patient has no additional vaccines administered on same date of the Pfizer vaccine and has no prior vaccinations (within 4 weeks). Patient with a history of severe osteoarthritis said she received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on 25Mar2021. The next day on 26Mar2021, she had terrible diarrhea, headache, ringing in her ears, dizziness, fever, chills and sweats. She was admitted to hospital from 29Mar2021 to 31Mar2021. Consumer wanted to know if she should still receive the 2nd dose. She further reported that she got her COVID-19 Vaccine late in the afternoon on 25Mar2021. She said she seemed fine after she got her COVID-19 Vaccine. She said the next morning on 26Mar2021, she woke up with terrible diarrhea, (really bad) headache, ringing in her ears, and dizzy. She said everything went sideways on 26Mar2021. She clarified she also had the chills, was soaking wet with sweat (but never seemed to have a fever). She said she was either sweating, freezing, or shaking with chills. She said she kept having diarrhea. She said on 29Mar2021 she had dry heaves with the diarrhea, and finally went to the Emergency Room. She said while she was at the hospital, she overhead hospital staff saying they thought she had the COVID-19 Virus. She said she treated as if she had the COVID-19 Virus by the hospital staff. She said she had a negative COVID-19 Virus nasal swab test, and the negative COVID-19 nasal swab test had come back within an hours-time on 29Mar2021. She said she was admitted to the hospital because she was dehydrated, and the doctor wanted to make sure she was over her diarrhea and getting better. The adverse events required a visit to the emergency room. She said she was hesitant about getting the second COVID-19 vaccine because of her severe side effects. She had blood work and a urinalysis done at the hospital in Mar2021. Diarrhea and dehydration treatment: Reported she took 3 doses of anti-diarrheal medication on 27Mar2021, and another dose on the morning of 29Mar2021 before she went to the Emergency Room. She said her diarrhea had kind of stopped after the morning of 29Mar2021, because she was unable to provide a stool sample when she went to the Emergency Room. Reported while she was admitted to the hospital, she was given IV fluids. She said she was unsure which IV fluids she was given. Patient reported she had recovered completely from all her reported symptoms in Mar2021.
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| 72 | 2021-04-23 | nausea |
she had a 102°F temperature/her temperature that went up to almost 102; headache/bad headache/horri...
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she had a 102°F temperature/her temperature that went up to almost 102; headache/bad headache/horrible headache; nausea; chills; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6201), second dose via intramuscular in upper left arm on 09Feb2021 at 16:30 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (Lot number: EL3249) via intramuscular in upper left arm on 19Jan2021 at 17:30 as single dose for COVID-19 immunization. In Feb 2021, about 30 hours after the second vaccine, the patient experienced 102 degree Fahrenheit/her temperature that went up to almost 102, headache/bad headache/horrible headache, nausea and chills. The patient underwent lab test and procedures which included body temperature was 102 degree Fahrenheit. Therapeutic measures were taken as a result of the events include baby aspirin. Then three hours later she took two more baby aspirin and her temperature went down after each time she took aspirin, states everything went down after the aspirin, the chills, nausea, and headache went down. She was reading literature and it looks like by taking an aspirin she may have stopped the production of antibodies. She is asking if this is true and if she has to be revaccinated or what she has to do. By the time she stared to go to bed she started to get a headache. She clarified that all of her other symptoms started in the middle of the night the same day she received the second dose. By 11Feb2021, in the early morning around 01:30am or 04:30am (both of the times she took aspirin) she recovered from all the side effects except she still has a very slight temperature. By 09:00 on 11Feb2021, her temperature was down to 100 or 99. The outcome of the event pyrexia was recovering, and was recovered for headache, nausea and chills.
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| 72 | 2021-04-24 | vomiting, diarrhea, abdominal pain upper |
Vomiting; Diarrhea; lost alot of weight; diverticulitis; brain fog, can't think clearly; stomach pai...
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Vomiting; Diarrhea; lost alot of weight; diverticulitis; brain fog, can't think clearly; stomach pains; violently ill; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient' medical history and concomitant medications were not reported. The patient experienced vomiting and diarrhea. Mostly diarrhea. The vomiting started 05Mar2021 in the middle of the night. She was vomiting so much she went to the Emergency room by ambulance. They kept her in the hospital for a couple of days, but she did not have diarrhea at this time. It was like three days later that she suddenly became violently ill. At the time she did not tie it to the vaccine administration, she thought she had food poisoning or something. She then had severe diarrhea. She cannot recall the exact onset date of when the diarrhea began. She can't get the dates together because she knows she became very sick. Patient recalls that when she got out of the hospital, she was having stomach pains. The stomach pains were feeling more severe on 18Mar2021. On 19Mar2021, she went to a check up with her gynecologist for an annual check up and did tell her gynecologist about the stomach pain and having a lot of stomach issues, but the doctor had no idea about it, she's a gynecologist. The patient's gastroenterologist thought maybe she had diverticulitis not related to the Pfizer COVID-19 vaccine and on 27Mar2021, they started her on Cipro and Flagyl, but the diarrhea just kept getting worse even with the meds and its just been getting worse and worse and worse. Cipro and Flagyl were stopped after 5 days because her gastroenterologist told her that maybe all of her flora was cleared out, and the flora was causing the diarrhea. No one knows what was causing her diarrhea. Oddly enough, she was feeling a little better today. She feels like she doesn't have diarrhea today, but she doesn't know because sometimes she has diarrhea for a couple of hours and then she feels just fine for a couple of hours. She also has brain fog. She was feeling like she could not think straight. She confirmed she does not have this feeling today. It got really bad after the second shot. The brain fog started between the time of first and second shot, when she had the diarrhea. It was like a week to ten days after the first shot, but she does not know exactly when brain fog started. It comes and goes, doesn't have it right now, and didn't have it yesterday. She stated that the brain fog seems to have gone away about 5 days ago. She had all these blood tests and cat scan and they all came back negative that she is in perfect health. She has no other issue except this constant diarrhea. Caller states she doesn't have any issues with any of her abdominal organs, her gall bladder and intestines are all fine. She has lost 5 pounds explaining that a month ago she weighed 136 pounds and now she weighs 130 pounds. The diarrhea is without any known medical known ideology and is very debilitating because she has lost a lot of weight. The outcome of events was reported as "unknown". Follow-up attempts are completed. The following information on the batch number has been requested.
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| 72 | 2021-04-25 | abdominal pain, nausea |
This 72 year old female received the Covid shot on 03/15/2021 and went to the ED on 4/3/2021 and...
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This 72 year old female received the Covid shot on 03/15/2021 and went to the ED on 4/3/2021 and was admitted on 4/3/2021 with abdominal pain, nausea, chest pain, NSTEMI and died on 04/24/2021 . Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.
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| 72 | 2021-04-26 | diarrhea, vomiting |
With in one hour patient experienced severe Vomiting and Diarrhea. She had called her Doctors offic...
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With in one hour patient experienced severe Vomiting and Diarrhea. She had called her Doctors office. She saw a PA which told her to drink more water. She experienced Uncontrollable Diarrhea For 18 days. She was sent to Hospital by ambulance on Monday March 15, 2021. She was was treated with an IV and sent home discharged with Weakness. She continued to have Uncontrollable Diarrhea to were she was wearing Diapers. She fell from Weakness on March 16, 2021 to the point where she laid on the floor for an hour and half before she could drag herself up. She went to Hospital on March 18, 2021. Her blood pressure dropped and was admitted to ICU on the March 18th. She started suffering from a Heart attack and was taken back to have a stent put in her wrist to help with possible heart blockage. She went into cardiac arrest and passed away.
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| 72 | 2021-04-30 | diarrhea, abdominal distension, flatulence |
respiratory distress issues; severe bloating; gas; diarrhea; This is a spontaneous report from a con...
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respiratory distress issues; severe bloating; gas; diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 01Mar2021 at 17:45 (Batch/Lot number was not reported) as single dose (at the age of 72 years-old), and dose 2 via an unspecified route of administration on 30Mar2021 (Batch/Lot number was not reported) as single dose (at the age of 72 years-old) for COVID-19 immunisation. Medical history included severe petro-chemical allergies: petroleum based products, etc. (i.e. gas - diesel fumes, sharpie pens,magic markers, paint, developers, paving materials). The patient had no other relevant medical history. The patient was not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine and no other medications within two weeks prior to the vaccine. On 03Mar2021 at 14:00 the patient experienced respiratory distress issues, severe bloating, gas, and diarrhea. The events resulted in doctor or other healthcare professional office/clinic visit. The patient reported the severe bloating, gas, diarrhea are now chronic issues, they are constant. The patient did not receive treatment for the respiratory distress issues. The patient received unspecified treatments from the physician for severe bloating, gas, diarrhea but the treatments have been unsuccessful. The events have been now ongoing for 6+ weeks and the patient stated they have ruled out glutten, dairy, etc as exasperators. The outcome of the events respiratory distress issues, severe bloating, gas, and diarrhea was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
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| 72 | 2021-04-30 | nausea |
like I was going to pass out.; felt nauseous; This is a spontaneous report from a contactable consum...
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like I was going to pass out.; felt nauseous; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 05Mar2021 at 15:30 (Batch/Lot Number: EN6203), at the age of 72 years old, as single dose for Covid-19 immunisation. Medical history included suspected covid-19 from Mar2020 to an unknown date (I believe I had Covid. Had all kinds of symptoms for many months after). The patient has no allergies to medications, food, or other products. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications received within 2 weeks of vaccination. The patient's concomitant medications were not reported. On 24Mar2021, 19 days after, the patient felt nauseous and like she was going to pass out. The patient underwent lab test which included Covid-19 test: unknown, in 2021. The patient did not receive any treatment for the events. Outcome of the events was recovering. No follow-up attempts are needed. No further information is expected.
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| 72 | 2021-05-04 | diarrhea |
activate autoimmune system ? effect on skin (dry , itchy on scalp/face) and organ (spleen?) -- > bo...
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activate autoimmune system ? effect on skin (dry , itchy on scalp/face) and organ (spleen?) -- > body fluid function: 1) tear gland ( dry eye, posterior capsular opacification)--YAG capsolotomy 2) salivary gland (extreme dry mouth -- > tooth decay --extraction of 3 teeth ; removal of gum abscess 3) reabsorption of fluid in GI (colon?) -- > 16 diarrah/day
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| 72 | 2021-05-04 | nausea |
She picked at a little bump and it started to bleed; little bumps on her chest; sunburn; Chest top o...
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She picked at a little bump and it started to bleed; little bumps on her chest; sunburn; Chest top of shoulders, back of shoulders turned bright red/ Her chest, shoulder, and upper part of back turned red; She was burnt, but did not have any blisters. She described her skin feeling like she poured peroxide on an open cut.; Nauseous; The inside of her body did not feel right. She felt like something was attacking the inside of her body.; sun allergy reaction; Rash on the top part of the chest; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 17Mar2021 15:00 (Lot Number: EN6202) in the arm as SINGLE DOSE for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient previously took advil [ibuprofen], tylenol regular and vitamins. The patient went on a boat ride two weeks later with minimal exposure to the sun and developed chest, top of shoulders, back of shoulders turned bright red. She put after sun lotion on and it didn't go away. She was told by her pharmacist to take bendryl and use cortisone with aloe. She used topical benadryl gel first and it wasn't helpful. She took oral liquid benadryl and was able to sleep. The patient stated, It felt like "I had an open wound and poured peroxide on it- my entire chest." She couldn't stand to have clothes on her chest. She did not develop any blisters. Her doctor recommended she not get the second dose so she missed the second dose. She believes that she had a reaction to the covid vaccine. She received the first dose of the covid vaccine, and the inside of her body did not feel right. She felt like something was attacking the inside of her body. A couple of weeks later, she went on a boat ride with her friends. Her chest, shoulder, and upper part of back turned red. She was burnt, but did not have any blisters. She described her skin feeling like she poured peroxide on an open cut. She tried treating it with aloe vera and a cloth with cold water. Hydrocortisone 1% with aloe vera made it hurt worse. She took liquid Benadryl and it put her to sleep. She has been reading up on side effects and about people calling to report. She thinks that she had a sun allergy reaction. The redness has still has not gone away. She now has little bumps on her chest. She is going to go to the dermatologist. She thinks that she had this reaction from the covid vaccine. She is 72 years old. She has never had anything happen to her like this before. She is out in the sun often. The day that she took the boat ride, she was only out for a little period. It goes from the upper part of her breast to her shoulder. She is not allergic to the sun, so she is not sure why she had a reaction. Because sun allergies are common, but not often reported, she wanted to call and report about her experience. The inside of her body did not feel right. She felt like something was attacking the inside of her body. It began on the same day she received the covid vaccine, 17Mar2021. It is now recovered completely. It lasted for several weeks, at least two weeks. Her chest, shoulder, and upper part of back turned red. She was burnt, but did not have any blisters. She described her skin feeling like she poured peroxide on an open cut: She clarifies that it is like a redness, like a sunburn. It began on 31Mar2021, two weeks after she received the first dose of the covid vaccine. It is a lot better now. But now she has these little bumps, she picked at a little bump and it started to bleed. She is asking about sun allergies. She is asking what can she do about this. She is asking if she can take anything. Hydrocortisone 1% with aloe vera made it hurt worse. She also used After Tan that had aloe vera in it. After Tan is a lotion made by Banana Boat that is sold over the counter. It is raining cats and dogs outside, so she is not able to go and get the bottle. She took liquid Benadryl and it put her to sleep. Benadryl gel made her skin burn. The patient had rash on the top part of the chest in Mar2021. The outcome of the event did not feel right, shoulders turned bright red and skin feeling like she poured peroxide on an open wound and nauseous was recovering. The outcome of the rest of the events was unknown. No follow-up attempts are needed. No further information is expected.
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| 72 | 2021-05-10 | decreased appetite |
Tiredness; Headache; Muscle pain; Joint pain; Chills; Fever; Feeling unwell; Cough; loss of appetite...
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Tiredness; Headache; Muscle pain; Joint pain; Chills; Fever; Feeling unwell; Cough; loss of appetite; Cataract; 'started feeling really ill'; painful injection site; A 72-years-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL9265, Expiration date: unknown), via an unspecified route of administration on 28Jan2021 in left arm at a single dose for covid-19 immunization. The patient's medical history included asthma, nerve injury, chronic nerve damage and blood pressure measurement. Patients concomitant medications included losartan for blood pressure abnormal at the dose of 100 mg per day, atenolol for blood pressure abnormal, albuterol (SALBUTAMOL)) for asthma at the dose of 1.25mg, esomeprazole sodium (NEXIUM) for gastroesophageal reflux disease. On 02Feb2021, she had a cataract implant on the right side. Which was the side her headaches were on. She didn't know if it was from the vaccine or not. Five days later after surgery, on an unspecified date in Feb2021, the patient experienced started feeling really ill. She was pending a procedure on her other eye as well. She got lots of symptoms. The patient experienced tiredness, headache muscle and joint pain, chills, fever, her injection site was painful, and she was feeling unwell. The patient underwent lab tests and procedures which included body temperature which was 101.2. A couple of days after the vaccine she felt well. On 05Feb2021, then all the sudden she just felt tired and couldn't do anything. She was laying and sitting all day. She had no appetite. It had persisted. She didn't have an appetite when she eats. She couldn't taste the food. She didn't feel as bad. She could feel herself getting better. She was taking more vitamin c and more vitamins. On same date, she had a cough. She had been taking Theraflu and lung support for her chest since she developed the cough. She had fever and which was up to 101.2. It kept fluctuating. This morning it was 96. She had muscle and joint every day, but this was triple the pain of her normal pain. She had been drinking a Gatorade. She took nexium for acid reflux, and she had been taking that for a while. That was why she thinks she couldn't taste as much. She got the vaccine because with everything going on, it was the right thing to do. The reporter assessed cataract as medically significant. The outcome of events tiredness, headache, muscle pain, joint pain, fever, feeling unwell was recovering, while chills, painful injection site were recovered, cough and loss of appetite were not recovered and the outcome of started feeling really ill was unknown. She was scheduled for her second dose on 18Feb2021.
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| 72 | 2021-05-12 | diarrhea, abdominal pain, abdominal pain upper |
burning between her belly button and breasts; sharp pain in her belly; arm felt like someone punched...
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burning between her belly button and breasts; sharp pain in her belly; arm felt like someone punched her; Severe Stomach Pain; stomach pain was unbelievable; So Much Diarrhea; Peeing out of her butt; This is a spontaneous report from a contactable nurse reporting for herself. A 72-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 13Apr2021 11:30 (Batch/Lot Number: ER8731) as single dose for covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient experienced severe stomach pain; stomach pain was unbelievable on 13Apr2021 with outcome of recovering , so much diarrhea; peeing out of her butt on 13Apr2021 with outcome of recovered on 17Apr2021 , sharp pain in her belly on 14Apr2021 with outcome of recovering , burning between her belly button and breasts on 15Apr2021 with outcome of recovered on 17Apr2021 , arm felt like someone punched her on 13Apr2021 with outcome of recovered on 15Apr2021. The patient underwent lab tests and procedures which included blood test: unknown on 26Apr2021. All the reported events were considered Important Medical Events. Causality: Caller stated yes, it is related to the vaccine. Stated she doesnt get diarrhea. Stated she eats healthy and doesnt ever get diarrhea, well maybe once in a blue moon. Caller states she thinks it is totally related to the vaccine. Follow up information has been requested. Lot number was already provided.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 73 | 2021-01-06 | decreased appetite |
Lot# is on card at work. Had COVID in April. Flu like symptoms. Tired, ached from head to toe. No ap...
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Lot# is on card at work. Had COVID in April. Flu like symptoms. Tired, ached from head to toe. No appetite. Went home and slept for 5 hours. Next day felt a little better. Today she is back to normal.
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| 73 | 2021-01-06 | nausea, vomiting | Strong nausea, vomiting and pallor. |
| 73 | 2021-01-08 | vomiting, nausea | Headache, Myalgia, Fever, NauseaVomiting, Chills Narrative: |
| 73 | 2021-01-17 | difficulty swallowing | PfizerBiontech EUA. Lightheaded, trouble swallowing |
| 73 | 2021-01-18 | decreased appetite, nausea |
Part of lip went numb right after, started getting nauseous, threw up several times. right breast ac...
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Part of lip went numb right after, started getting nauseous, threw up several times. right breast ached. Slept all day yesterday. since injection no apatite. Had night sweats.
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| 73 | 2021-01-19 | difficulty swallowing |
Fatigue, generalized aching, Mild- moderate right side sore throat and slight soreness back and swel...
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Fatigue, generalized aching, Mild- moderate right side sore throat and slight soreness back and swelling back of roof of mouth and tenderness neck glands unilaterally. Difficult/painfulswallowing -takes considerable effort to swallow.
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| 73 | 2021-01-19 | vomiting |
Severe vertigo with jittering eyes, loss of balance, vomiting. Started Antivert on 1/19/2021 at 7:45...
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Severe vertigo with jittering eyes, loss of balance, vomiting. Started Antivert on 1/19/2021 at 7:45 pm. Better, but still very dizzy. Vomiting has stopped.
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| 73 | 2021-01-20 | nausea | pain and swelling at injection site, nausea and body aches |
| 73 | 2021-01-22 | vomiting | Vomited multiple times after lunch approximately 2 hours after shot. |
| 73 | 2021-01-23 | abdominal pain upper | Itching Pain in elbows, shoulders & knees Pain in stomach (not upset) Vertigo |
| 73 | 2021-01-24 | decreased appetite |
Caregiver stated the patient woke up next day complaining about being achy, feverish, entire body ac...
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Caregiver stated the patient woke up next day complaining about being achy, feverish, entire body aches and no strength. Caregiver stated on 1/23/2021 patient was having same symptoms with loss of appetite and fatigue. On 1/25/2021 caregiver noticed 2x2 red spot around the injection site that warm sore to touch. Caregiver reached out to the PCP and was told to keep an eye on red spot and put a damp warm rag on it.
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| 73 | 2021-01-25 | vomiting |
Throwing up, violently; This is a spontaneous report from a contactable consumer. A 73-year-old fema...
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Throwing up, violently; This is a spontaneous report from a contactable consumer. A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283), via an unspecified route of administration in right arm on 12Jan2021 11:30 AM at for COVID-19 immunization. Medical history included breast cancer, heart valve problem, asthma, and allergies. The patient's concomitant medications were not reported. The patient experienced throwing up, violently on 12Jan2021 11:30 AM. Patient dose not have COVID prior vaccination. Patient was not tested for COVID post vaccination. No treatment was received for the adverse event. The outcome of the event was recovering.
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| 73 | 2021-01-27 | vomiting, nausea |
Nausea and vomiting beginning 12 hours after injection, headache, muscle weakness, painful injection...
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Nausea and vomiting beginning 12 hours after injection, headache, muscle weakness, painful injection site
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| 73 | 2021-01-28 | nausea |
overall soreness, extreme soreness in arm, headache, flulike symptoms: chills, weakness, fatigue, na...
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overall soreness, extreme soreness in arm, headache, flulike symptoms: chills, weakness, fatigue, nausea, dizziness (the last two symptoms were brief)
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| 73 | 2021-01-28 | nausea | Pt. c/o flushing/burning in vaccinated arm, nausea and light headed. |
| 73 | 2021-01-31 | diarrhea |
Approximately 39 hours after receiving the shot, I experienced severe diarrhea. It continued for fo...
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Approximately 39 hours after receiving the shot, I experienced severe diarrhea. It continued for four hours. Upon waking in the morning the symptoms had ceased and I felt well. While I have Ulcerative Colitis, I do not believe this event was related to it. It was not food related. Also, as I have had a C.diff problem in the past and am taking Vancomycin daily, it did not appear to be related to that.
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| 73 | 2021-01-31 | nausea | Sore arm with soreness and itching, next day headache and nausea |
| 73 | 2021-02-01 | difficulty swallowing |
Patient reported an anaphylactic reaction (throat swelling, trouble breathing) to ibuprofen. She al...
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Patient reported an anaphylactic reaction (throat swelling, trouble breathing) to ibuprofen. She also indicated she developed a rash all over her body to a flu vaccine in 1970s, attributed to her egg allergy. Due to her extensive allergies and the fact that she has not gotten a vaccine since 1970s, I would need to monitor her for 30 minutes. (Even though none of her allergies cross react with ingredients in covid Pfizer vaccine. I gave patient vaccine and had her sit in waiting room to be monitored. After 5 or so minutes I noticed her head down, I asked if she was feeling okay she said yes just very tired. I asked if any trouble breathing she said no but her mouth feels dry. Another five minutes go by and patients head is down again, I again ask if she is okay she says yes just very tired and she wasn't before vaccine. I ask if any trouble breathing/swallowing, she said it's a little hard to swallow but she thinks its because her mouth is dry. I get patient a water and ask if she is okay if I give her a Benadryl. She says yes so I give her 50mg Benadryl by mouth. Another 5 minutes go by and again I have to ask patient how she was feeling, she said fine. I ask how her throat is, she says it just feels kind of tight. Due to this progression of allergic reaction (although slow, clearly progressing) I told patient I will have to call for an ambulance. Paramedics showed up after 5-10 minutes and took care of patient. I relayed all this info to them as well as the dispatcher on the phone. Paramedics took patient to hospital conscious and breathing on her own.
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| 73 | 2021-02-01 | nausea, decreased appetite |
she thinks she broke the sweat/big sweat; couldn't eat anything/was not even eating; She had the chi...
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she thinks she broke the sweat/big sweat; couldn't eat anything/was not even eating; She had the chills; nausea; She had a terrible headache; Feeling freezing cold; she was going to faint; She thought she was losing her mind; slight pain in her arm/sore arm/sore spot; She feels weak, and is still weak; She couldn't walk; This is a spontaneous report from a contactable consumer (patient). A 73-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1283) via an unspecified route of administration in the left arm on 10Jan2021 at single dose for COVID-19 immunization. There was no medical history. There were no concomitant medications. The patient had the first dose of the vaccine on 10Jan2021 and didn't have a reaction, but had a slight pain in her arm on 10Jan2021. Her sore arm started on 11Jan2021. There was a sore spot and when she would pick up her arm it was sore and achy. No pain, but sore and achy. It lasted for a day or two. She didn't have any symptoms until Saturday the 16Jan2021, this past Saturday she thought she was dying. She had chills, nausea, feeling freezing cold, and had a headache. She thought she was losing her mind. The headache just stopped today. She had the chills that would not stop and she thinks she broke the sweat on Sunday (17Jan2021). She had a little nausea and couldn't eat anything on 16Jan2021. She had a terrible headache, which just stopped about 2 hours ago. She stated she must have to take 10 Tylenol over the course of time, every 4 hours. On Saturday 16Jan2021 she was just laying on the floor in pain. She was not even eating, just drinking water. All of her symptoms stopped this morning around 5 AM (18Jan2021). She had a big sweat. She is unsure if she had a fever because she does not have a thermometer. She is unsure if she has recovered completely from these symptoms. She feels weak, and is still weak (on Jan2021). She cannot go out or get dressed or shower. She is not strong enough. She is just sitting up now, no longer laying in bed. She couldn't walk (on Jan2021) and was afraid she was going to faint on 16Jan2021. She can walk a little bit now and feels a little bit better. She has been out of it for three days, She hasn't felt good. She asked if side effects can appear 6 days later? Is this normal to have a reaction 1 week after getting it? She asked are the side effects worse after the second dose? She asked is this Covid or side effects, what are the COVID symptoms? She asked should she take the second one if she had these side effects? Caller clarifies this is the Pfizer COVID Vaccine. Whoever vaccinated her did not give her the paper about it afterwards. Her neighbor brought it to her cause they went together. She did not realize she could experience these things. She did not expect them a week after getting the vaccine. She thought she had COVID. She asks, "do you think I have COVID?" She is just now getting better and it has been 3 days of experiencing these symptoms. Should she get the second vaccine? She is trying to do the right thing. Event outcome of chills, nausea, feeling freezing cold, and headache was recovered on 18Jan2021, for was going to faint and couldn't walk was recovering, for weak was not recovered, while for others was unknown.
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| 73 | 2021-02-02 | diarrhea, nausea |
Had shot at 4:26pm Ate a light dinner(lentil soup and omelette) Woke up around 2:30 am felling naus...
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Had shot at 4:26pm Ate a light dinner(lentil soup and omelette) Woke up around 2:30 am felling nauseas and had diarhea and chills which continued through the night and following day. Very weak and passed out briefly when feeding my dogs.Ate a bland diet and drank plenty of water for the next few days. Felt better on Saturday January 30th
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| 73 | 2021-02-03 | nausea, abdominal pain |
PAIN, TENDERNESS AND SWELLING OF LYMPH NODES IN SAME ARM AS INJECTION- LASTED 4 DAYS., FATIGUE,HEADA...
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PAIN, TENDERNESS AND SWELLING OF LYMPH NODES IN SAME ARM AS INJECTION- LASTED 4 DAYS., FATIGUE,HEADACHE, AND NAUSEA FOR 24 HOURS.
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| 73 | 2021-02-03 | nausea, decreased appetite |
Light headed; lack of appetite; achy; nauseous; sick feeling; This is a spontaneous report from a co...
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Light headed; lack of appetite; achy; nauseous; sick feeling; This is a spontaneous report from a contactable consumer (Patient). A 73-Year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EH9899), via an unspecified route of administration at Arm Right on 07Jan2021 10:30 at the 73 years old at single dose for COVID-19 immunization. The medical history was none. The concomitant medications were vitamin C (ascorbic acid), atorvastatin (strength 5 mg), valsartan (strength 80 mg). There was no other vaccine in four weeks. On15Jan2021 08:00 the patient experienced Light headed, lack of appetite, achy, nauseous, sick feeling. The events were continuing though lighter for at least another 3 days. There was no treatment received for all the adverse events. The patient had no Covid prior vaccination. There was covid tested post vaccination. The patient underwent lab tests and procedures, which included Nasal Swab negative on 18Jan2021. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 73 | 2021-02-03 | nausea | FEVER, BODY ACHES, MILD SORE THROAT, NAGGING HEADACHE, NAUSEA, AND CHILLS |
| 73 | 2021-02-04 | nausea | Sinus headache, nausea, joint pain |
| 73 | 2021-02-05 | diarrhea |
Temperature 101.3, severe headache, chills, fever, diarrhea, body aches, unable to move left arm, hi...
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Temperature 101.3, severe headache, chills, fever, diarrhea, body aches, unable to move left arm, high heart rate, difficulty breathing
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| 73 | 2021-02-05 | nausea |
Patient presented to the ED shortly after receiving her COVID vaccine with hypertension, altered men...
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Patient presented to the ED shortly after receiving her COVID vaccine with hypertension, altered mental status, and a near syncopal episode upon arrival at the ED. Patient also reported some throat tightness and nausea. Patient received the first does of the Pfizer COVID vaccine about one hour PTA. Patient began having hypertension noted to be in the 180-215 systolics and patient reports baseline of 120s systolic. Patient was brought directly from the vaccine clinic to the ED. Upon arrival at the ED, patient experienced a syncopal episode and eventually came out of this but was confused. It was reported in the notes that patient was slightly dehydrated which could have contributed to her symptoms. Once the patient recovered from this episode and hypertension was resolved, patient was discharged home to follow up with PCP.
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| 73 | 2021-02-06 | difficulty swallowing |
Persistent Swollen tight uncomfortable throat, initially a burning sensation ~ 12 hours, difficulty...
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Persistent Swollen tight uncomfortable throat, initially a burning sensation ~ 12 hours, difficulty swallowing cleocin cap and foods, dry cough This is my second day with symptoms
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| 73 | 2021-02-06 | nausea |
Within 15 minutes started feeling nauseous which has continued, varying in intensity, as I write thi...
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Within 15 minutes started feeling nauseous which has continued, varying in intensity, as I write this. Additionally today, suddenly I started feeling hot and weak. I checked my oxygen level which was fine at 98, but my pulse was fast at 115 when it is normally in the low to mid 70s and I was just cooking. When I took my blood pressure, it was 142 over 125 a blood pressure than is normal for me. I took a table of Inderal 10mg and within an hour my blood pressure was normal at 117 over 86. My pulse was also 73.. So for now I?m ok.
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| 73 | 2021-02-07 | nausea, decreased appetite | Had nausea and fatigue, no appetite |
| 73 | 2021-02-07 | nausea |
Pfizer-BioNTech COVID-19 Vaccine EUA: Soon after reciving vaccination patient stated they "felt weir...
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Pfizer-BioNTech COVID-19 Vaccine EUA: Soon after reciving vaccination patient stated they "felt weird", reported nausea and shortness of breath, and were found to have a blood pressue of 200/96 mmHg despite taking blood pressure medications that day. Patient was transported to the emergency department during which they had a brief episode of unresponsiveness and were non-interactive. On initial exam in the emergency department patient symptoms were improving: speech, sensation, and cranial nerves are intact, normal strength in all extemities, lungs are clear, and there is movement in all extremities. No rash, wheezing, or respiratory distress noted. Repeat vitals within normal ranges except blood pressure 151/87. Patient administered medication for nausea. Symptoms resolved and patient discharged to home stable.
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| 73 | 2021-02-08 | nausea |
Vertigo and nausea started Sunday Jan 31 and has persisted. Worse in a.m. upon arising. Still have l...
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Vertigo and nausea started Sunday Jan 31 and has persisted. Worse in a.m. upon arising. Still have lingering symptoms.
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| 73 | 2021-02-09 | abdominal pain upper |
Itching; Pain in elbows, shoulders and knees; Pain in stomach; Vertigo; This is a spontaneous report...
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Itching; Pain in elbows, shoulders and knees; Pain in stomach; Vertigo; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, lot/batch number not provided), via an unspecified route of administration on the left arm on 22Jan2021 08:30 at SINGLE DOSE for COVID-19 immunization at the Public Health Department. Medical history reported as none. The patient's concomitant medications were not reported. On 23Jan2021 23:45, the patient experienced itching, pain in elbows, shoulders and knees; pain in stomach and vertigo. The patient was not diagnosed with COVID-19 prior and not tested since vaccination. No treatment was received for the events. The patient had not recovered from the events. Information about lot and batch number was requested.
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| 73 | 2021-02-09 | nausea |
Vaccine at 12:20 pm. Side effects started out with arm pain and then chills and nausea.the same as w...
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Vaccine at 12:20 pm. Side effects started out with arm pain and then chills and nausea.the same as when had first dose. 4:30 pm -acetaminophen 500mg 10:30pm severe right arm and shoulder pain 8/10. Nausea 11:30 acetaminophen 500 mg. Was trying to not take any medication for fear it would effect negatively the vaccine efficacy. continued nausea Did not sleep first night kept waking groaning in pain/R arm shoulder 5:00 am acetaminophen 500 mg body aches and continued severe arm pain. 10:40 am acetaminophen 500 mg " and " and nausea 11:30 am severe body aches, chills and fever 99* with 500mg Acetaminophen. my Normal temp (96.8) 3:30 pm "
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| 73 | 2021-02-10 | nausea |
Pt without contraindications to receive vaccine. Vaccine given at approx. 1125. Patient waited requi...
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Pt without contraindications to receive vaccine. Vaccine given at approx. 1125. Patient waited required 15 min. w/o reaction. Pt remained for husband's 15 minute wait. During this time, patient felt dizzy and nauseousl and generally weak at 1150. Nourishments provided without relief. Rapid response called at 1155. Team arrived assessed patient. VS179/81 82 pulse, O2 - 96%. Dr. from Urgent Care came to check patient. Told to observe patient and repeat VS, patient ok per Dr. VS repeated at 1215 - 185/92, pulse 84, O2 sat 98%. Patient with c/o pressure to chest, chills and hives. Patient remained stable, husband present. 911 called. EMS Station 28 B shift arrived at 1225 and assumed care of patient. 1245 Ambulance arrived Unit 217 assumed care of patient.
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| 73 | 2021-02-14 | diarrhea | fever, diarrhea, headache, sore arm, sore underarm, mouth sores (cheeks, tongue, under tongue, gums) |
| 73 | 2021-02-14 | nausea |
Patient is a 73 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the CO...
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Patient is a 73 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15-minute waiting period after the injection, the patient began to experience lightheadedness and headache, flushed, left deltoid where vaccination given hot to touch, nausea. She denied rash, difficulty breathing, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality, rapid progression of symptoms, respiratory distress and skin changes. Patient with flushing, headache, left arm warm to touch, and nausea after first vaccine administration of Pfizer in the 15-minute waiting period. Blood pressure elevated, SpO2 is 98-99% on room air, pulse 68. Patient notes that she has reactions with medications and vaccines. Water provided. After sitting for a few minutes, patient reports that she is no longer lightheaded, headache is almost gone, nausea has resolved. ALLERGY REVIEW OF SYSTEMS: Waves of nausea: Lightheaded with some dizziness, headache: Previous Reactions: Adverse reactions to medications in the past. Objective Vitals Vitals: 02/09/21 1145 BP: (!) 179/63 Pulse: 68 SpO2: 98% Physical Exam Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic. Mouth/Throat: Mouth: Mucous membranes are moist. Eyes: Extraocular Movements: Extraocular movements intact. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Musculoskeletal: General: No swelling. Right lower leg: No edema. Left lower leg: No edema. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: water and patient took Tylenol before vaccine administration Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) Patient feeling back to normal. BP 152/76 at 1203. All symptoms have resolved. Left deltoid without swelling, redness, rash. Patient ambulating without difficulty. She is cleared to drive home. If she should have symptoms return or worsen, she is to call PCP or go to ER.
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| 73 | 2021-02-14 | vomiting, nausea | vomiting, nausea, headache, fever, chills, fatigue |
| 73 | 2021-02-15 | difficulty swallowing, nausea |
Date and time adverse event started: #1 vaccine cause swelling and pain to injection arm several hou...
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Date and time adverse event started: #1 vaccine cause swelling and pain to injection arm several hours after shot then was better the next day, was itching. #2 vaccine on right arm but it almost immediately caused numbness and tingling to left arm, felt tired. ~2 hours after vaccine, felt generalized pain and exhaustion, headache started, then 2 hours later developed chills and shivering, T 99F, leg cramps, nausea, difficulty swallowing and speech garbled. Numbness, tingling, dysphagia and speech garbled eased up after about 24 hours. She took APAP and icepack to neck to ease headache. Stayed in bed most of the time, didn't sleep well. Headache subsided, continued to have chills and aches. Now has lingering fatigue, today has "ears on fire," chills and nauseous. Brand and lot of vaccine: Pfizer#1lot FL9262, Pfizer#2lot EL9267 (caller stated it is hard to read) Date and time of vaccination: (list both if they received both shots): #1 Pfizer Jan 23, 2021
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| 73 | 2021-02-15 | vomiting, abdominal pain upper |
chills, sweats, (no fever), severe stomach cramping, vomiting for 24 hours, called immunologist, pre...
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chills, sweats, (no fever), severe stomach cramping, vomiting for 24 hours, called immunologist, prescribed medication to stop nausea, son had to drive 4 hours to be with me for 48 hours until I could hold liquids. Day 4 after onset much better. Day 5, getting back to normal.
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| 73 | 2021-02-16 | flatulence, nausea, indigestion, abdominal pain upper |
psychedelic feeling; horrible palsy, as if her muscle was being pulled like a rubber band; horrible ...
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psychedelic feeling; horrible palsy, as if her muscle was being pulled like a rubber band; horrible palsy, as if her muscle was being pulled like a rubber band; the worse bowel movement. She had to go the bathroom a lot; Her right arm was the worse with the pain and then her hands would kind of move in a kind of crazy way where it was tightening; muscle cramping and pulling; Her toes would contort and go backwards.; she feels like the left arm is going to do something, its like the last to be pulled; shingles; muscles became tight/contort; minor nausea; Stomach cramps; Gas; Indigestion; became weird in her head, almost like a lightheadedness; This is a spontaneous report from a contactable consumer. A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), intramuscular on 30Jan2021 at 10:00 at a single dose on right arm for COVID-19 immunisation. Medical history included fever, being ill (deathly ill and it lasted for three weeks) and bug bites from an unknown date and unknown if ongoing. There were no concomitant medications. The patient is the type of person that takes a lot for her to take medications. She is allergic to a lot of things; she always has crazy reactions. She can't take morphine. It took her 7 pills to get the right one for high blood pressure. She has the craziest one-day reactions. She received the COVID-19 vaccine on Saturday much against her will, knowing she had COVID but not diagnosed in March. She had a fever, she was deathly ill and it lasted for three weeks. She had a nasal swab done and it came back negative. She doesn't think that was right, she believes she had COVID-19 in Mar2020. Her daughter is younger, and she had the same thing, she couldn't breathe good for 3 weeks. She had pneumonia. She knows she had COVID-19. She was trying to lose weight. She was given her first COVID-19 vaccine by a doctor. Everything was going okay at first. About an hour and a half later, she became weird in her head, almost like a lightheadedness. She can't describe it. She has never taken drugs. She doesn't drink alcohol at all. She has like a virgin body. She states plus she is red headed, which it is known red heads have a harder time with medication. As the day goes on, she just felt lightheaded all the rest of the day. The next day (Sunday, 31Jan2021), she wakes up and it hits her like a ton of bricks. She woke in the morning and seemed to be okay and then it was like she was pregnant and blew up. She started cramping really bad and had gas. Everybody has gas. She was a little nauseated as well. She experienced lots of indigestion, cramping in her stomach like she was going to have a baby or the worse bowel movement. She had to go the bathroom a lot. She had a little bit of nausea. She had nausea pills because she had a gallbladder taken out and she took nausea pills for 2-3 days. She didn't take any medication for any of these symptoms she started to experience on Sunday. However, she did start popping Gas-X. She was taking two Gas-X every 3 or 4 hours. The caller states it helped. She had lots of gas; gas was just coming out of her bottom. She had the gas, cramps, her stomach hurt. She was able to get through it, which that is good. Then Monday, 01Feb2021 was the day she had weird things happen to her that she was kind of concerned about. Her muscles started to draw, that is the best way she can describe it. Her feet would just draw up weird. Her arms and hands would do crazy things and contort or draw up. This hurts because the muscles are like a rubber band pulling. It was weird, and she didn't like it. It wasn't like when she has a horse and has to get up and stand, it wasn't like that at all. Her muscles were tightening up like a rubber band. Her right arm was the worse with the pain and then her hands would kind of move in a kind of crazy way where it was tightening. She thought to herself, "what is this Parkinson's?". She doesn't even know. She still has some stomach issues, but it is easing up. The gas is still coming out. It wasn't debilitating or anything. She has some minor nausea. What scared her more was the muscle cramping and pulling. Her toes would contort and go backwards. The muscle tightness occurred yesterday, 01Feb2021. It happened all day and was sporadic. Her toes moved in a different way like a rubber band pulling on muscle. Nothing has happened today. Everything was yesterday. Her whole body basically was affected, just different sections at different times. Today, she feels like the left arm is going to do something, it's like the last to be pulled. Her hands and fingers stayed the same. She explains like the upper arm area from her elbow to her shoulder part. She can't even think of what that area is, but it's the part between her elbow and shoulder. She has been doing lots of exercises and moving, hoping the part of her elbow to her should don't atrophy or won't pull. She hasn't told anybody about it. She doesn't like it. It was very frightening. She is scheduled for her second shot and she is scared to death to go back. She mentions her nerves are shot. From stress, she had previously broken out instantly. She thought it was a bug biting her. She never had gone to the doctor but after about 4 weeks, she thought she had these horrible bug bites. She was shaking her clothes and she almost wanted to strip it was so bad. She thought it was severe bug bites. She couldn't figure it out. She finally went to the doctor after a week. It was a Saturday. The doctor told her it was shingles. Explained that it itches a lot. She went on medication. She clarifies she went on acyclovir 800mg, three pills a day. She called her doctor knowing that she had shingles and how scared she is with medicine, the doctor assured her she could get the COVID-19 shot as scheduled. The medicine for shingles (acyclovir) was finished up the Friday before she received the COVID-19 vaccine. She got the shingles shot at 60 but everybody is now saying to get the new shot for shingles which she has never done obviously since she got the shingles. She plans to get the shingles shot in the summer. She is not worried about it. She took 3 pills a day and that was fine. She is fine, meaning every day she did normal things going through the whole process. She states she plans to go to the bank. She asked if anybody has reported the reaction she experienced after receiving the first dose of the Covid vaccine. She received the first dose of the vaccine last Saturday, in which within an hour and a half her "brain got weird, like a psychedelic feeling and it felt like I was getting an injection in the operating room to go to sleep." On Monday she experienced, "horrible palsy, as if her muscle was being pulled like a rubber band." Stated that it wasn't a horse feeling. Her hands and fingers would pull and contort in different positions, in which they would remain tight and stay in that position, and then she would be able to make a closed fist. On Monday night, her left arm contorted (which is not administration arm) and her muscle became really tight from her elbow to her wrist leading to her hand contorting as well. She describes the muscle tension as if a rubber band was being pulled, it would have burst. This muscle pulling hurt, in which she took 3 ibuprofen (ADVIL). She has crazy reactions with almost anything that she takes. She has never smoked or drank. The patient underwent lab tests and procedures which included COVID-19: unknown on an unspecified date and unknown on Mar2020, SARS-COV-2 test: negative on an unspecified date. Therapeutic measures were taken as a result of gas (flatulence), muscles became tight/contort, minor nausea, horrible palsy, as if her muscle was being pulled like a rubber band and shingles. The outcome of the event 'the worse bowel movement. She had to go the bathroom a lot' was not recovered while of the rest of the events was unknown.
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| 73 | 2021-02-17 | nausea, vomiting |
At 4am I woke up sweating/sweating profusely; nausea/extremely nauseous; dizziness/dizzy/extremely d...
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At 4am I woke up sweating/sweating profusely; nausea/extremely nauseous; dizziness/dizzy/extremely dizzy; vomit; lost bladder control; I was very weak, I couldn't wipe. I couldn't hold a cloth/had no hand strength; terrified, I thought I was dying never experienced anything like this in my life/ she did not know if she was dying, she thought she it was possible, she never felt that way in her life; a little arm pain; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team. A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at deltoid left on 26Jan2021 at 13:20 (at the age of 73 years) at single dose for COVID-19 immunization. The patient medical history was none. There were no concomitant medications. The patient reported a little arm pain on 26Jan2021, I woke up sweating/sweating profusely, nausea/extremely nauseous, dizziness/dizzy/extremely dizzy and vomit , all on 27Jan2021 at 4:00; lost bladder control, terrified, I thought I was dying never experienced anything like this in my life/ she did not know if she was dying, she thought she it was possible, she never felt that way in her life, and those are classic heart attack symptoms, she had no cardio and respiratory symptoms; I was very weak, I couldn't wipe. I couldn't hold a cloth/had no hand strength, all on 27Jan2021. Therapeutic measures were taken as result of little arm pain an included treatment with aspirin. The patient outcome of the events was recovered. The information on the batch number has been requested.
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| 73 | 2021-02-18 | nausea |
Exactly 12 hours after the shot, I experienced a severe wave of nausea, dizziness, faintness, and bo...
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Exactly 12 hours after the shot, I experienced a severe wave of nausea, dizziness, faintness, and body sweats that lasted 15 minutes. It gradually subsided.
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| 73 | 2021-02-21 | nausea |
This is not a critical reaction but want to report in order to help build up the information availab...
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This is not a critical reaction but want to report in order to help build up the information available to healthcare professionals going forward. Morning after chills, neck stiffness, pain back of head left side. Applied heating pad to neck. By late morning I was nauseous , and weak as a kitten. Took a 500 mg Tylenol and slept for about 4 hours. Woke up in a sweat but chills gone and am now able to eat a little bit. Back of head and neck still very sore. The injection site is sore but no rash; right arm seems to have "phantom pain" as well ( I experienced this with Shingles shot in December 2020 too).
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| 73 | 2021-02-22 | vomiting |
Symptoms occurred about a week after the first AND the second covid vaccination. Lot number of fir...
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Symptoms occurred about a week after the first AND the second covid vaccination. Lot number of first is EI9262 and of second (as above) EN6201. In addition to expected fatigue and chills (I experienced no sore arm or fever) I developed symptoms of gallbladder attack with extreme abdominal pain and vomiting. These lasted for just over 2 days.
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| 73 | 2021-02-23 | abdominal pain upper, abdominal discomfort |
Upset stomach a few hours after injection. Next day Saturday left arm sore at shot area, and contin...
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Upset stomach a few hours after injection. Next day Saturday left arm sore at shot area, and continued upset stomach. Sunday night slight cramping in stomach. Monday AM Full blown cramping , afternoon 99.2 fever, chills, hands cold continued severe cramping. Took Tylenol. Tuesday slight cramping from stomach to rectum, normal temp. Wednesday slight cramping comes and goes. Feeling much better.
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| 73 | 2021-02-23 | abdominal pain |
2/6/2020 and 2/7/2020: severe chills/horrible headache--rizatriptan 2/11/2020 through 2/14/2020: sev...
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2/6/2020 and 2/7/2020: severe chills/horrible headache--rizatriptan 2/11/2020 through 2/14/2020: severe abdominal pain; low backahe; headache--aleve and rizatriptan 2/21/2020 through 2/25/2020 severe stiff neck; headache; aleve X4 pills Only a sore arm from the fist vaccine.
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| 73 | 2021-02-24 | abdominal pain upper, abdominal pain |
On Feb. 12th at 2PM symptoms started with lower back pain, pain in abdomen and stomach, cramping, ch...
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On Feb. 12th at 2PM symptoms started with lower back pain, pain in abdomen and stomach, cramping, chills, ear ache, pain level 8. Felt sick all over, like having the flu and then whole body ached, not just GI track. Left arm injection site was red, sore to touch, swollen (slightly). Doctor couldn't get vaccination needle into arm muscle the first time and so had to try a second time. Intense cramping of GI track started up again 8:45AM on Feb. 13th. By 4PM Feb. 15th fever 102F, chills, felt freezing cold and had to wrap myself in a heating blanket. Pain level 10, especially in pancreas. Fever broke around 2:30AM Feb. 16th and later when I was up at 8AM I felt very weak, faint, pancreas ached. Pancreatic pain lasted another 3 days. Pancreatic pain stayed around level 5. On Feb. 17th took ibuprophen. Pain level reduced to 1. This was the only time that I took pain medication between Feb. 10th and 17th, because I am conservative about using Ibuprophen, Tylenol, and have a high threshold for pain.
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| 73 | 2021-02-24 | nausea |
Tingling of fingers and numbness of left cheek. Did not get any worse after 30 minutes. Extremely t...
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Tingling of fingers and numbness of left cheek. Did not get any worse after 30 minutes. Extremely tired and sore arm that day. Day 2 - tired easily, no stamina. Dizzy and nauseous after showering at3:30 pm. By 10:30, both hands were red and itched. Sometime in the night woke with a very sharp, painful headache. Did not last. No real problem again until Saturday. Nausea at 11:20 am. Sunday I sat all day doing taxes - no symptoms noted. Monday after walking - rapid heart rate and very tired after what is normal activity. By 4:30 I was tingling all over my body. Tuesday night my ankles are swollen for the first time in years. Only happened that nigh. Wednesday morning, the tingling is very strong in my calves. and I had a sharp pain in the area of my Achilles tendon. I believe that the vaccine has exacerbated the neuropathy (undiagnosed) of the bottom of my feet. Today I am reporting because I fell for no reason getting out of a chair, and the tingling is in my legs, arms, shoulders. I had not heard until today that the vaccine could affect the nervous system. The effects are the worst they have been and it has been one week since I had the vaccine. Should I get the second shot? Due March 11,2021.
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| 73 | 2021-02-25 | nausea, constipation, vomiting |
Patient was tired and slept for two days after vaccine. Then had nausea and general "blah" feeling ...
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Patient was tired and slept for two days after vaccine. Then had nausea and general "blah" feeling for the next 2 1/2 weeks and had nose bleeds. On Day 4 she did vomit. After second shot, she complained of constipation and aching on over. She vomited twice.
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| 73 | 2021-02-25 | nausea |
Fever 101.9; severe headache; muscle aches; joint pain; weakness; brain fog; lethargy; nausea; This ...
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Fever 101.9; severe headache; muscle aches; joint pain; weakness; brain fog; lethargy; nausea; This is a spontaneous report from a contactable nurse (patient). A 73-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Feb2021 at 10:30 at single dose in right arm for COVID-19 immunisation at the age of 73-year-old. Lot number was EM9810. The patient was not pregnant at the time of vaccination. Medical history included asthma, psoriasis, psoriatic arthritis, cardiac arrhythmia. Past drug history included allergy to Tetracycline. Concomitant medications included metaprolol, montelukast sodium (SINGULAR), simethicone (PEPSID), clonixin lysinate (SKELAXIN), Vitamin D. On 04Feb2021, the patient experienced fever 101.9, severe headache, muscle aches, joint pain, weakness, brain fog, lethargy, nausea. Fever and headache continue 9 days after the injection. On 11Feb2021, Covid test at one week was negative (nasal swab). The patient was treated with Tylenol. The patient did not recover from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has been tested for COVID-19.
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| 73 | 2021-02-26 | diarrhea, decreased appetite |
extreme fatigue,sore guns,canker sores,loss of appetite,diarrhea, rectal bleeding, no smell, no tast...
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extreme fatigue,sore guns,canker sores,loss of appetite,diarrhea, rectal bleeding, no smell, no taste, extreme thirst rash on front of both legs and both arms,night sweats, runny nose
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| 73 | 2021-02-26 | diarrhea |
sore upper left arm 2 days, fatigue 5 days, muscle & joint pain 5 days, diarrhea 4th day rested a...
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sore upper left arm 2 days, fatigue 5 days, muscle & joint pain 5 days, diarrhea 4th day rested and slept for fatigue took Tylenol first 2 days, and ibuprofen thereafter for pain took bismuth subsalicylate for diarrhea
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| 73 | 2021-02-26 | indigestion |
Fatigue, shortness of breath, digestive issue, headache. Symptoms took 10 days to mostly go away. ...
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Fatigue, shortness of breath, digestive issue, headache. Symptoms took 10 days to mostly go away. Still have shortness of breath. Took Tylenol and got lots of sleep.
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| 73 | 2021-02-26 | nausea |
Slightly elevated temp, mild nausea, chills, muscle aches, fatigue, mild headache. All this started ...
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Slightly elevated temp, mild nausea, chills, muscle aches, fatigue, mild headache. All this started 6 days after the vaccine. On the 6th night after the shot, symptoms lasted about 8 hours. Then started up worse during the night of the 7th day, especially the chills, elevated temp, fatigue and nausea. Symptoms such as the chills are starting to subside about 10 hours later but some such as mild fatigue still remain. Is this normal for symptoms to show up nearly a week after the shot?
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| 73 | 2021-02-26 | nausea | Nausea dizziness and hives |
| 73 | 2021-02-27 | nausea |
Fever, chills, muscular aches, nausea...approx. 14 hrs. after injection...had a "tin" taste immediat...
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Fever, chills, muscular aches, nausea...approx. 14 hrs. after injection...had a "tin" taste immediately after the injection, lasting about 15 minutes
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| 73 | 2021-02-28 | nausea, decreased appetite, diarrhea |
Nausea, diarrhea, rib cage pain so bad I couldn't lie down/sleep, exhaustion, Muscle aches and pain,...
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Nausea, diarrhea, rib cage pain so bad I couldn't lie down/sleep, exhaustion, Muscle aches and pain, loss of appetite, cough,
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| 73 | 2021-02-28 | nausea |
Pt. c/o lightheadedness, nausea and burning sensation at site 10 minutes after receiving the vaccine...
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Pt. c/o lightheadedness, nausea and burning sensation at site 10 minutes after receiving the vaccine. Client assessed by EMS and vital signs are B/P 115/80, HR 75, 02 98. After 20 min. of continuous observation client stated that she started to feel better. Pt. advised to stay another 15 min then cleared to go home by EMS.
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| 73 | 2021-02-28 | nausea |
Headache nausea chills weakness severe arm pain right arm . Recovered in 10 hours followed by ...
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Headache nausea chills weakness severe arm pain right arm . Recovered in 10 hours followed by slight headache for several days.
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| 73 | 2021-02-28 | vomiting |
has had a fever since this time; her ileostomy had a blockage that day and she vomited all night; he...
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has had a fever since this time; her ileostomy had a blockage that day and she vomited all night; her ileostomy had a blockage that day and she vomited all night; it was very severe and sore and she is just getting over the soreness; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL1283, first dose) solution for injection intramuscular in left deltoid on 18Jan2021 at 14:20 (at the age of 73-years-old) at single dose for COVID-19 vaccination. Medical history included ongoing type 2 diabetes, ongoing active carcinoid cancer of liver, ongoing Ileostomy from Jul2002, surgery in 2001, second primary colon tumor, acid reflux and neuropathy in feet and legs. Concomitant medications included amlodipine besilate for blood pressure, lisinopril for blood pressure, metformin, sitagliptin phosphate (JANUVIA) and gabapentin. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient has had a fever since this time on 18Jan2021 and was very severe and sore and she is just getting over the soreness in Jan2021. Temperature was 102 F on 18Jan2021, 101 F on 19Jan2021, the having a fever in varying degrees like 99 F or 100 F after in Jan2021. On 18Jan2021, her ileostomy had a blockage that day and she vomited all night. Treatment for the event fever included ibuprofen (ADVIL). The outcome of the event fever was not recovered. The outcome of the events vomited and ileostomy had a blockage was unknown. The outcome of the event pain was recovering.
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| 73 | 2021-03-01 | nausea, decreased appetite |
Chills and fever began at approx. 1:30 a.m. on February 27. Continued until late mid-day on March 1...
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Chills and fever began at approx. 1:30 a.m. on February 27. Continued until late mid-day on March 1. Extreme weakness and nausea. Had no appetite. Very dry mouth. Fever lessened by evening of March 1. Weakness and feeling of lightheadedness continuing as of today, March 2, morning. No more nausea today. No fever today Able to eat small amount of food
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| 73 | 2021-03-01 | nausea | Chills, nausea, fatigue soreness and stiff at shot site. |
| 73 | 2021-03-01 | nausea |
Mild nausea; This is a spontaneous report from a contactable consumer (patient). A 73-years-old fema...
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Mild nausea; This is a spontaneous report from a contactable consumer (patient). A 73-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 28Jan2021 18:30 at single dose (right arm) for covid-19 immunization. Medical history included allergies, asthma and Clostridium difficile (c.dif). Patient had allergies to medications, food or other products. The patient was not pregnant. Concomitant medication included rosuvastatin within 2 weeks of vaccination. The patient received other vaccine within 4 weeks prior to Covid vaccine included 1 dose of pneumonia vaccine on 07Jan2021 at a clinic. On 28Jan2021 18:30, the patient experienced mild nausea. Treatment was not received for the event. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, patient has not patient been tested for covid-19. Outcome of event was recovered on an unspecified date. Information on the lot/batch number has been requested.
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| 73 | 2021-03-02 | abdominal pain, abdominal pain lower |
severe cramps; mild headache; lower abdominal pain across lower abdomen; This is a spontaneous repor...
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severe cramps; mild headache; lower abdominal pain across lower abdomen; This is a spontaneous report received from a contactable consumer (patient). A 73-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN5318), on 15Feb2021 at 09:30 AM (at the age of 73-year-old) on left arm at single dose for COVID-19 immunization. It was reported that patient was not pregnant at the time of event and at the time of vaccination. The patient's medical history was reported as none including no known allergies and no covid prior vaccination. The patient's concomitant medications included simvastatin (ZOCOR). The patient previously received the first dose of BNT162B2 (lot number EL1283), on 25Jan2021 09:30 AM (at the age of 73-year-old) on left arm for COVID-19 immunization, no other vaccines were administered in four weeks prior to vaccination. On 16Feb2021 at 10:00 AM the patient experienced mild headache severe cramps and lower abdominal pain across lower abdomen. The event "severe cramps" was reported as serious with criteria medically significant while the other events were reported as non-serious. No treatment for the events was received. No covid test was performed post vaccination. The outcome of the events was not resolved.
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| 73 | 2021-03-02 | vomiting, diarrhea |
Diarrhea and vomiting Unable to keep anything, even water, down until 2:00 pm...still on soda cracke...
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Diarrhea and vomiting Unable to keep anything, even water, down until 2:00 pm...still on soda crackers and Gatorade at 3:00. Chills around 3:00 pm Fatigue This may have been a food-poisoning incident. If so, I don?t know the source, but it feels like food poisoning.
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| 73 | 2021-03-03 | abdominal pain, diarrhea | Severe abdominal pan and diarrhea |
| 73 | 2021-03-03 | constipation |
She was in her usual state of health until January 26 when she received her first dose of the Pfizer...
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She was in her usual state of health until January 26 when she received her first dose of the Pfizer COVID-19 vaccine and the second dose on February 18, 2021. Within 4 days of receiving this vaccine she noticed she fell on Monday, February 22 she was able to raise herself up she fell again on Tuesday, February 23 and on Thursday, February 24. By Friday she could not get up and she presented to hospital where she was noted to have lower extremity weakness. An MRI has revealed extensive edema of the whole of the spinal cord extending from the cervical region to the sacral area. She has lost motor function and sensation to the lower extremities as well. She has not had a bowel movement since Thursday, February 24 and she has had to have a Foley catheter placed because of difficulties passing urine.
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| 73 | 2021-03-03 | diarrhea |
Temp of 100 degrees, muscle aches, chills lasted about 24 hours. Following day three episodes of dia...
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Temp of 100 degrees, muscle aches, chills lasted about 24 hours. Following day three episodes of diarrhea
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| 73 | 2021-03-03 | nausea, vomiting, retching |
food poisoning; First got really sick; nausea/She got sick to her stomach; head colds/feels like com...
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food poisoning; First got really sick; nausea/She got sick to her stomach; head colds/feels like coming down with a cold; Feeling unwell/she wasn't feeling well; Dry heaved for 40 minutes. Saliva in her stomach was coming up, not food. Felt like it lasted forever.; sinus problems.; vomiting; Pain injection site; Slight headache; Chills, feels like coming down with a cold; Tired; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 73-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: RL3249), via an unspecified route of administration at left arm on 26Jan2021 14:00 (also reported as 17Jan2021 - pending clarification) at SINGLE DOSE for COVID-19 immunisation. The patient had no prior vaccinations within 4 weeks. Medical history included diabetes, cancer (prior to receiving COVID-19 shot. Stated she was 14 years cancer free), allergy, shingles shot which hurt at the injection site, shrinks every year (Doesn't know exact number, but a little under 5 feet). The patient had no family medical history. Concomitant medication included mometasone furoate (FLONASE [MOMETASONE FUROATE]). On an unspecified date, the patient experienced she got sick to her stomach, food poisoning, "nausea/She got sick to her stomach," "head colds/feels like coming down with a cold," "feeling unwell/she wasn't feeling well," "dry heaved for 40 minutes. Saliva in her stomach was coming up, not food. Felt like it lasted forever," sinus problems, vomiting, and first got really sick. On 26Jan2021, the patient experienced tired, slight headache, chills feels like coming down with a cold, and pain injection site. The patient reported that she received the first dose of the Pfizer vaccine and experienced side effects including nausea, head colds, and sinus problems. She was concerned that this may be covid and if it will be safe for her to get the second dose of the vaccine as scheduled. The patient further reported that she first got really sick. Never had the flu and always gets head colds or food poisoning on an unspecified date. After reading material passed out, perhaps she was treating COVID and not a cold or allergy. The patient took first COVID-19 shot on 26Jan2021. Thought everything was fine. The patient was close to bedtime then noticed she wasn't feeling well. Looked at side effects and has like six of them at the same time. Right as she was going to rest, she got sick to her stomach. Never was sick to her stomach except when she was food poisoned. The patient had dry heaved for 40 minutes. Saliva in her stomach was coming up, not food. Felt like it lasted forever on an unspecified date. The patient asked that if she does have COVID, should she take the second shot? Wanted to get tested because Pfizer materials says exactly what her headache and sinus stuff was about. Now she was scared. The patient also reported that she wanted to take the second COVID-19 shot. If she does have COVID, thinks it's not the thing to do right now. It was confirmed she has not had a positive COVID test after receiving the first COVID-19 shot. Should have read material prior to and maybe wouldn't have taken the first COVID-19 shot. Confirmed symptoms she mentioned occurred after the COVID-19 shot. The patient came home from COVID-19 shot feeling fine. Didn't get sick until close to bedtime. Appointment for COVID-19 shot was 2:30PM. Clarified six symptoms previously mentioned: The patient had pain at injection site just two days and was gone. Began shortly after she got home from the COVID-19 shot. Went to lift arm up and it didn't feel good. Began an hour or two after COVID-19 shot. The patient was tired unusually early in the day. Felt like she didn't want to do anything. Couldn't use her left arm. Clarified left arm was injection arm. Tiredness has subsided and only lasted a couple of days. It was further reported that patient never gets headaches. It started after vomiting which didn't last long. It bothered her and then was gone by the time she went to sleep. The patient had chills, feels like coming down with a cold on an unspecified date which subsided right before dinner around 3PM-4PM. The patient had to put on a fluffy robe to keep warm. It was also reported that the patient did not have a fever. It was also reported that shingles shot hurt at injection site where pain lasted a week and a half. Temperature went from 98.6 degrees to 99 degrees. The patient was taking stuff now and monitoring to see if she can see any signs. The patient was feeling unwell on an unspecified date which has subsided except for allergies and she was concerned. The patient also experienced dry heaving: didn't have anything in her stomach on an unspecified date which subsided. Even after she ate yesterday, hasn't had any dry heaving except for night of the COVID-19 shot. The patient underwent lab tests and procedure which included body height: little under 5 feet (doesn't know exact number), temperature: went from 98.6 degrees to 99 degrees, and COVID test: negative (she has not had a positive COVID test after receiving the first COVID-19 shot). Therapeutic measures were taken as a result of sinus disorder which included sinus medication and was squirting Flonase in her nose. On an unspecified date, the patient recovered from slight headache. The patient had not yet recovered from the event nausea and vomiting. The outcome of the events chills, tired, food poisoning, first got really sick, head colds/feels like coming down with a cold, feeling unwell/she wasn't feeling well, dry heaves, sinus problems, and pain injection site were unknown.
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| 73 | 2021-03-03 | nausea |
PATIENT FELT DIZZY AND NAUSEOUS RIGHT AFTER RECEIVING THE VACCINATION. SHE WAS ASKED TO WAIT 30 MINS...
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PATIENT FELT DIZZY AND NAUSEOUS RIGHT AFTER RECEIVING THE VACCINATION. SHE WAS ASKED TO WAIT 30 MINS POST ADMINISTRATION AND RIGHT BEFORE SHE LEFT WE CHECKED THAT THE PATIENT FELT MUCH BETTER AND NAUSEA WENT AWAY .
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| 73 | 2021-03-03 | vomiting, nausea |
She has immune issues and stress/ methylprednisolone for immune issues; She has immune issues and st...
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She has immune issues and stress/ methylprednisolone for immune issues; She has immune issues and stress/ methylprednisolone for immune issues; severe headache/ pain in the base of her skull; nausea; vomiting; had pain at the top of her spine where the spine meets the skull; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (BNT162B2, lot number: EL9264) via an unspecified route of administration, on 01Feb2021 12:45PM at a single dose on top of left arm for COVID-19 immunization. The vaccine was given at a Clinic which is an off shoot of the hospital. The patient did not receive any vaccinations within 4 weeks prior to receiving BNT162B2. Medical history included Wegner's disease, immune issues and stress. She stated that there would be one doctor providing medication for stress and other doctor providing other medications. She has immune issues and stress. Concomitant medications included buspirone from an unspecified date and ongoing (been on it for quite a few years), clonazepam from an unspecified date and ongoing (been on it for quite a few years), fluticasone propionate (FLOVENT) from an unspecified date and ongoing (been on it a little over a year or two and it was prescribed by her pulmonologist), hydrochlorothiazide, triamterene (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) from an unspecified date and ongoing (has been on it for more than 5 years and was prescribed by her primary care), methylprednisolone for immune issues, bupropion hydrochloride (WELLBUTRIN), and nebulizer for saline for Wegner's disease (It is prescribed by her ear, nose, and throat doctor). The patient previously received a flu shot in 2020 and experienced sore arm and achy feeling. On 01Feb2021 18:45, the patient experienced severe headache, nausea, vomiting, and pain in the base of her skull. A lot of people thought it was throwing her into a migraine. She has never had a migraine in her life. It was awful and pretty extreme. Severe headache, nausea, vomiting, and pain in the base of her skull started about six hours after the shot (at 18:45) and proceed a good 24 hours later. She also had pain at the top of her spine where the spine meets the skull. She would say that the symptoms stopped on 02Feb2021. She has recovered almost completely. She is still not quite completely 100 percent. The reported adverse events did not require a visit to emergency room or physician office. Some relatives said she should have gone in, but she did not. Outcome of the events was recovered on 02Feb2021.
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| 73 | 2021-03-04 | diarrhea |
severe diarrhea lasted 2weeks and 2 days. Self treatment with Brac diet, stayed hydrated. reduced st...
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severe diarrhea lasted 2weeks and 2 days. Self treatment with Brac diet, stayed hydrated. reduced stress. Lots of chicken soup broth. called physician and assured her would follow up.
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| 73 | 2021-03-04 | nausea |
Itchy tongue tip, slight dizziness, nausea. BP 143/72 (pulse 76), O2 sat 98%. BP 143/76 (pulse 77), ...
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Itchy tongue tip, slight dizziness, nausea. BP 143/72 (pulse 76), O2 sat 98%. BP 143/76 (pulse 77), O2 sat 99%.
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| 73 | 2021-03-04 | vomiting |
tenderness at injection site, low grade fever, aching in all joints-started at 12:30-7;30 3/5/21, 3 ...
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tenderness at injection site, low grade fever, aching in all joints-started at 12:30-7;30 3/5/21, 3 doses of advil,vomiting
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| 73 | 2021-03-05 | diarrhea, nausea, vomiting | Nausea Vomiting Diarrhea Headache Chills Rash, Pain, Swelling, Redness at site area |
| 73 | 2021-03-05 | nausea | Hot sweaty thirsty Slight nausea At night whole body chills Whole body shivers Fever |
| 73 | 2021-03-05 | vomiting, diarrhea |
Started vomiting at 5 o?clock morning after the shot. Went to ER at 3 o?clock in the afternoon, was ...
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Started vomiting at 5 o?clock morning after the shot. Went to ER at 3 o?clock in the afternoon, was administered IV and vomiting was stopped about 4 o?clock in the afternoon. Severe diarrhea, intense headache. Was given nausea medicine and medicine to stop diarrhea, medicine for headache. Was sent home with prescriptions for nausea, diarrhea.
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| 73 | 2021-03-06 | nausea, retching |
Fatigue in afternoon following injections. Then proceeded by chills, fever, and nausea during the n...
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Fatigue in afternoon following injections. Then proceeded by chills, fever, and nausea during the night (including dry vomiting). Chills laster another day, and fatigue (frequent naps) lasted for two more days. Total of 4 days of adverse conditions.
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| 73 | 2021-03-06 | nausea |
Extreme muscle pain, followed by severe headache, exhaustion, chills ,nausea 4 days after first covi...
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Extreme muscle pain, followed by severe headache, exhaustion, chills ,nausea 4 days after first covid shot
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| 73 | 2021-03-07 | diarrhea, vomiting | vomited next morning and diaherra |
| 73 | 2021-03-07 | diarrhea |
Severe breathing distress lasting 3 days Diarrhea 2 days. Injection site pain. Headache joint pAin...
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Severe breathing distress lasting 3 days Diarrhea 2 days. Injection site pain. Headache joint pAin Fatigue
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| 73 | 2021-03-07 | nausea | Weakness, nausea, fever. Symptoms lasted approximately 36 hours. |
| 73 | 2021-03-07 | vomiting, abdominal discomfort, abdominal pain upper, decreased appetite, diarrhea, nausea |
3/4 Evening: injection site VERY sore. Too painful To sleep on. Disturbed sleep due to pain. 3/5:...
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3/4 Evening: injection site VERY sore. Too painful To sleep on. Disturbed sleep due to pain. 3/5: Morning; headache, fatigue Evening/overnight: arm still tender 3/6: Morning: fatigue, nausea, headache, lack of appetite, stomach upset. Hot flashes, no fever detected Afternoon: very nauseous, vomiting, headache Evening/overnight: not getting restful sleep 3/7: Morning: mild headache/lack of appetite Evening/overnight: woke in the middle of the night with severe stomach cramps, loose stool, nausea amd vomiting. No fever detected. 3/8 continues to be nauseous, lack of appetite and extreme fatigue.
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| 73 | 2021-03-08 | nausea | nausea, throat feels tight. Evaluated by EMS- Cleared |
| 73 | 2021-03-08 | nausea |
Arm is very sore and it hurts in the muscle, this is very sore in the spot where they give me the in...
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Arm is very sore and it hurts in the muscle, this is very sore in the spot where they give me the injection; I have a slight fever of a 100; I feel I am cold, I have the chills; Headache; joint pain; muscle pain unbelievable; nauseous; I was sick all day; symptoms felt like when you are getting the flu and when you get the flu vaccine; tiredness; sweating; This is a spontaneous report from a contactable consumer, the patient. This 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1, single dose via an unspecified route of administration on 05Feb2021 (at the age of 73 years-old) for COVID-19 vaccination. Medical history included Parkinson's disease, bulging disc in the back and shoulder, anxiety, thyroid, had very bad case of, was in the hospital for 12 days and they were just supposed to put her on the ventilator, but then started to recover a little bit, was hesitating on taking the shot. But when she called the doctors they said no you can take it, even the neurologist said that you can take it because she had this disease and should be taking it. Historical vaccine included unspecified reaction from an unspecified flu vaccine on an unknown date. Concomitant medications included dexlansoprazole (DEXILANT), levothyroxine, paroxetine for anxiety, carbidopa, levodopa for Parkinson's disease, metoprolol succinate (METOPROLOL ER ACTAVIS) 25 mg, one a day and vitamin D NOS. On 05Feb2021, the patient experienced slight fever of a 100, felt cold, chills, headache, joint pain, muscle pain unbelievable, nauseous and was sick all day. On 06Feb2021, the patient's arm was very sore in the spot where they gave the injection and has no rash, it's not red in that area or any place else, It's just very sore and it hurts in the muscle, this is very sore in the spot where they gave the injection. On an unknown date in 2021, symptoms felt like when you are getting the flu and when you get the flu vaccine just a little more tiredness. Treatment to reduce the fever included acetaminophen (TYLENOL) and is sweating. Treatment was received for chills. The clinical outcome of slight fever of a 100, felt cold, chills was recovered on an unknown date. The clinical outcome of arm very sore in the spot where they gave the injection, headache, joint pain, muscle pain unbelievable, nauseous, sick all day, symptoms felt like when you are getting the flu and flu vaccine, tiredness and sweating was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 73 | 2021-03-08 | nausea |
Chills, fever 101, Body aches, fatigue, Headache, nausea, swollen glands, SOB. started on 2/27 gradu...
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Chills, fever 101, Body aches, fatigue, Headache, nausea, swollen glands, SOB. started on 2/27 gradually improved and then a week later on 3/6/21 experienced body aches, chills , fever, chest tightness, headache which has resolved by 3/8/21..
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| 73 | 2021-03-08 | nausea |
10 minutes post vaccine pt felt nauseous. Drank water and was encouraged to relax and sit in propped...
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10 minutes post vaccine pt felt nauseous. Drank water and was encouraged to relax and sit in propped up position
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| 73 | 2021-03-08 | vomiting |
13 days after my first vaccine shot I awoke with chills, fever, temp, vomiting and body aches. It la...
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13 days after my first vaccine shot I awoke with chills, fever, temp, vomiting and body aches. It lasted two days although better the second day. Low grade fever followed on and off for several days.
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| 73 | 2021-03-09 | abdominal pain upper, nausea |
Heavy cramping of internal stomach organs early AM (2AM) of second day. Nausea second and 3rd day. ...
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Heavy cramping of internal stomach organs early AM (2AM) of second day. Nausea second and 3rd day. Regurgetated 3rd day.
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| 73 | 2021-03-09 | indigestion | Headache, chills, indigestion; muscle aches; fatigue |
| 73 | 2021-03-09 | nausea |
Chills, nausea, aches and slight dizziness with some fatigue. These lasted for approximately 14 hou...
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Chills, nausea, aches and slight dizziness with some fatigue. These lasted for approximately 14 hours.
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| 73 | 2021-03-09 | nausea | Severe headache, slight nausea, very sore arm, tiredness. Lasted through the day and evening |
| 73 | 2021-03-10 | vomiting, diarrhea |
Severe vomiting and diarrhea for 12 hours. Received shot at center. Called at noon on 3/10 and got...
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Severe vomiting and diarrhea for 12 hours. Received shot at center. Called at noon on 3/10 and got prescribed ONdansetron 4MG. The vomiting stopped about an hour later. Am still weak this morning. VERY concerned about getting second shot.
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| 73 | 2021-03-11 | nausea |
Sore arm as expected. Fatigue (still in effect, ) Severe headache ( helped/resolved by Tylenol). Som...
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Sore arm as expected. Fatigue (still in effect, ) Severe headache ( helped/resolved by Tylenol). Some queasiness/dizziness
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| 73 | 2021-03-12 | nausea, decreased appetite |
nausea, elevated temp, excessive urination, swollen soft tissue (mouth, tongue), painful urination -...
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nausea, elevated temp, excessive urination, swollen soft tissue (mouth, tongue), painful urination - bladder and kidneys, extreme weakness, no interest in food.
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| 73 | 2021-03-12 | vomiting, nausea |
Nausea, Sudden vomiting, extremely low blood pressure, and then started having a seizure... no previ...
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Nausea, Sudden vomiting, extremely low blood pressure, and then started having a seizure... no previous seizures or seizure disorders.
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| 73 | 2021-03-14 | abdominal pain |
I have had pancreatitis before and it felt like the same thing; About 5 hours after I had the Covid ...
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I have had pancreatitis before and it felt like the same thing; About 5 hours after I had the Covid shot I experienced severe abdominal pain, really the whole front of my chest below my breasts to my waist.; This is a spontaneous report from a contactable consumer reported for herself. The 73-year-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, Brand: Pfizer, lot number: EN6201) via an unspecified route of administration on 22Feb2021 14:30 on left arm at single dose for covid-19 immunisation. Medical history included arthritis from an unknown date and unknown if ongoing, pancreatitis from an unknown date and unknown if ongoing, Allergies to medications, food, or other products: codeine, hydrocodone, amoxicillin, provostatin, narcotics, CT scan contrast IV dye. Concomitant medication included gabapentin, amlodipine, meloxicam, calcium, centru. The patient previously took first dose of bnt162b2 (COVID 19, Brand: Pfizer, lot number: EN5318) on 01Feb2021 01.45 PM on left arm at single dose for covid-19 immunisation, codeine and experienced drug hypersensitivity, hydrocodone and experienced drug hypersensitivity, amoxicillin and experienced drug hypersensitivity. The patient experienced "i have had pancreatitis before and it felt like the same thing" on 22Feb2021 08:30AM with outcome of recovered, "about 5 hours after i had the covid shot i experienced severe abdominal pain, really the whole front of my chest below my breasts to my waist" on 22Feb2021 08:30AM with outcome of recovered. Therapeutic measures were taken as a result of the events included IV and blood and urine tests. She is not pregnant or not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The consumer reported that "About 5 hours after I had the Covid shot I experienced severe abdominal pain, really the whole front of my chest below my breasts to my waist. I have had pancreatitis before and it felt like the same thing. I went to the emergency room and indeed had lipase at 3640. The painful part of attack was over within another hour. This was my 5th attack of pancreatitis and I don't know if the vaccination triggered it or not. It is unknown at this time why I have had the pancreatitis attacks. I don't drink or have gall stones." Ae resulted in Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19.
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| 73 | 2021-03-14 | nausea, diarrhea, vomiting |
None with Shot 1 Shot 2 : Headache, fatigue, nausea, vomiting, diarrhea, nightmares, unclear thinki...
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None with Shot 1 Shot 2 : Headache, fatigue, nausea, vomiting, diarrhea, nightmares, unclear thinking, instability on feet 2days recovery except for headache and fatigue remain Imodium Zofran Sumatriptan Fully recovered except for headache and fatigue
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| 73 | 2021-03-14 | nausea |
chills, fever, headache, nausea, weakness, and arm pain at site. Called Dr. spoke with staff and tol...
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chills, fever, headache, nausea, weakness, and arm pain at site. Called Dr. spoke with staff and told it will go away in a couple of day. Stayed in bed all day on the 12th of March and woke up about 8:00 on the 13th and only symptom which I still have today is sore arm at point of vaccination. other meds Lorazepam .05mg,Aspirin 81 mg, Acyclovir 400 mg, Vita D, Vita B12,Align, Estroven. Turmeric, One a day vitamins,Coq10
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| 73 | 2021-03-14 | nausea | Headache, Fever (100.4), nausea, fatigue. Lasted thru the entire day. |
| 73 | 2021-03-14 | nausea |
Developed COVID. Fever, chills, muscle aches, runny nose, cough, nausea, headaches, fatigue, loss ...
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Developed COVID. Fever, chills, muscle aches, runny nose, cough, nausea, headaches, fatigue, loss of taste and smell
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| 73 | 2021-03-14 | nausea |
Developed COVID. Detected by PCR. Had fever, chills, muscle aches, runny nose, nausea, headaches, f...
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Developed COVID. Detected by PCR. Had fever, chills, muscle aches, runny nose, nausea, headaches, fatigue, loss of taste and smell.
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| 73 | 2021-03-16 | abdominal pain, vomiting, nausea |
32 hours post vacc. injection, administered at a medical center (a community site-not my primary pro...
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32 hours post vacc. injection, administered at a medical center (a community site-not my primary provider), Sx began w/ nausea, low abdominal pain, stiff neck and achy pain at base of skull. W/in 20 minutes nausea became vomiting x5 events which stopped when Ondansetronws taken, authorized by an on-call physician at the clinic (my primary care provider). Chills w/out fever begun about 30 minutes post first episode of vomiting and continued into the earliest hours of 2/28/21 (4:00am). I reviewed my Sx not only with the clinic staff, but also my primary care physician on 3/2/21. She has provided prn Rx for possible Sx as needed for dose 2, March 19th, 2021.
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| 73 | 2021-03-16 | diarrhea |
Fever, Headache, Diarrhea, Fatigue, generally feeling bad After 9 days got covid test which was nega...
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Fever, Headache, Diarrhea, Fatigue, generally feeling bad After 9 days got covid test which was negative. Then went to doctor for diarrhea which was really bad( 4-6 times a day. Stool test diagnosed me with c diff. On antibiotic until March 20,2021, Diarrhea getting better but not back to normal
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| 73 | 2021-03-16 | nausea |
Patient received 2nd dose of Pfizer COVID-19 vaccine. She immediately developed diaphoresis and eye...
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Patient received 2nd dose of Pfizer COVID-19 vaccine. She immediately developed diaphoresis and eye tearing. Diaphoresis worsened. Patient reported nausea. Epinephrine administered and transferred patient to emergency department. ED did not feel epinephrine helped Patient observed and then discharged.
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| 73 | 2021-03-16 | vomiting |
3:56pm- 71/F in post vaccination area witnessed multiple episodes of vomiting yellow emesis. Appears...
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3:56pm- 71/F in post vaccination area witnessed multiple episodes of vomiting yellow emesis. Appears diaphoretic, initial BP 220/110, HR 110. O2 95%, RR 22. Pt received the vaccine at 3:46pm. She denies blurred vision, no headache, no chest pain or SOB. Denies abdominal pain but her daughter states she recently had a hernia repair and has had issues with cyclic vomiting induced with certain foods or stress, which her doctors are monitoring her for. Her daughter states she was feeling sick before she got her vaccine. Patient states she took her morning medication at 7am, had some breakfast at 10am and states she feels it was some pineapple she ate that caused her to start feeling nauseous. She adds that she is taking several blood pressire medications but when she begins to vomting her blood pressure "gets really high." Pt is AOx4, able to speak in clear complete sentences. 4:05pm- BP 210/120, HR 82, 97%, RR 24. Pt continues to vomit intermittently but states she is starting to feel better. Onsite nurse manager, lead and site lead aware. EMS services requested. 4:10pm- BP 191/100, HR 86, 96%. No vomiting witnessed. 4:14pm- Ems arrives on scene. BP sitting 156/91, standing 140/92. Pt states she feels better. Parameduc offers to transfer her to the hospital but patient declines. Her daughter is at side and she states she would rather her daughter take her home since she is feeling better. Educated regarding when to seek medical attention. Pt AOx4, resp even, skin warm and dry, not actively vomiting, speaks in clear complete sentences. Assisted to POV via wheelchair. Pt in no apparent distress.
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| 73 | 2021-03-16 | vomiting | Fever, Chills, Vomiting, Weakness, Tired, Rapid Heartrate |
| 73 | 2021-03-17 | vomiting, nausea, diarrhea |
On 03/08/2021, patient began not feeling well. She complained of nausea, vominting and diarrhea. He...
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On 03/08/2021, patient began not feeling well. She complained of nausea, vominting and diarrhea. Her husband reported that she received the first vaccine in 02/2021 and complained of not feeling well. Patient died on 3/12/2021.
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| 73 | 2021-03-18 | nausea | Dizziness/light-headed, nausea/quesey, tiredness |
| 73 | 2021-03-19 | nausea, abdominal discomfort |
Started with chills and upset stomach. After about 30 minutes felt sick to my stomach, still chills...
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Started with chills and upset stomach. After about 30 minutes felt sick to my stomach, still chills and felt weak. Went to bed with normal covers, spread and an extra quilt. Temperature was 101.0. stayed in bed until noon then went to the couch. Still felt weak and extremely tired. Temp down to 99 but developed a bad headache. Took Tylenol and laid on the couch all day - did not eat still felt queasy. Went to bed around 8:00pm. Got up about 10:00 on Friday and felt almost back to normal and got better as the day went on. I also noticed quite a bruise at the site.
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| 73 | 2021-03-19 | nausea |
3 hours after extreme nausea. 10 hours after shaking chills(rigors) lasting in waves for 6 hours the...
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3 hours after extreme nausea. 10 hours after shaking chills(rigors) lasting in waves for 6 hours then intermittently for 5 hours. Low grade Temp 100.3 Degrees , when I could take it. Inconvenience of urine during the rigors. ?Migraine like? headache on right side involving my teeth for 12 hours and slowly abated after 24 hours. Unable to eat or drink for 42 hours with exception of one cup green tea and 1/2 slice of provolone cheese., forced down only to take my Pradaxa. After rigors, whole body sweats for 8 hours. As of today, I have had plain oatmeal and tea.
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| 73 | 2021-03-19 | nausea | Sore right arm, fever, nausea chills, rash, headache |
| 73 | 2021-03-19 | vomiting, diarrhea | Vomiting,diarrhea, chills joint pain all joints, dizziness Exhausted, breathlessness |
| 73 | 2021-03-20 | nausea |
3/10 could not stay awake beyond 9PM 3/11 10 AM, tired, nauseous, continued to 8PM when could no lo...
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3/10 could not stay awake beyond 9PM 3/11 10 AM, tired, nauseous, continued to 8PM when could no longer stay awake, slight aching at injection site 3/12 slept 10 hours, continue to feel tired, less energy to present date 3/21/21.
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| 73 | 2021-03-20 | vomiting, nausea | nausea, vomiting, dizziness. Evaluated by EMS-Cleared |
| 73 | 2021-03-20 | vomiting, nausea |
Woke up around 10 am, turned to my head to the left in bed, and had extreme virtigo, nausea and one ...
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Woke up around 10 am, turned to my head to the left in bed, and had extreme virtigo, nausea and one bout of vomiting. After a two hour nap felt better although still fatigued and a little off. Next day still fatigued and off but virtigo disappeared.
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| 73 | 2021-03-21 | diarrhea, vomiting | Exhaustion, headache, fever, muscle aches, joint paint, chills, vomiting, diarrhea, dizziness |
| 73 | 2021-03-21 | nausea, diarrhea |
Symptoms of muscle ache, then fever, then chills.started late afternoon, Tue., March 16, at 4:15 pm....
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Symptoms of muscle ache, then fever, then chills.started late afternoon, Tue., March 16, at 4:15 pm. At 2:am next morning, March 17, sudden severe nausea and diarrhea, severe headache, hot flashes and sweats continued for 2 hours. Intermittent syncope twice.
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| 73 | 2021-03-22 | abdominal discomfort | patient felt tired sleepy with an upset stomach |
| 73 | 2021-03-22 | decreased appetite |
AT 3:00am on Monday 3/15/2021 I woke up with severe headache & body aches. I was disoriented & leth...
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AT 3:00am on Monday 3/15/2021 I woke up with severe headache & body aches. I was disoriented & lethargic. My friend came over took my blood pressure it was 144/75 I was freezing and the room was 80degrees I had absolutely no appetite. My head felt like it was going blow up Next day was Tuesday 3/16/2021 I woke still groggy & bad headache but now I was hallucinating & i was burning up & sweating profusely Next day 3/17/21 still out of sync & very disoriented Thursday 3/18/21 had video dr appt at 1:00pm he told me to ride it out gave me something to sleep & some tramadol for pain Friday 3/19/21 started coming out of it I felt like i was dying if thats what it feels like
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| 73 | 2021-03-22 | flatulence | painful arm that received the vaccine, gas and cramping, headache, fatigue, stiffness |
| 73 | 2021-03-24 | nausea |
Woke up at 3:00 am drenched in cold sweat, unable to focus, loss of equilibrium, nausea. Feeling be...
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Woke up at 3:00 am drenched in cold sweat, unable to focus, loss of equilibrium, nausea. Feeling better by noon. ongoing waves of brain fog, pressure behind my eyes. I seek no treatment, hope it will improve with time. Would like to know if it is advisable to have the second dose. I do not want to repeat the previous experience. Are you able to advise? Thank you
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| 73 | 2021-03-25 | abdominal pain |
Chills; fatigue; Severe abdominal cramping; Gallbladder attack; This is a spontaneous report from a ...
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Chills; fatigue; Severe abdominal cramping; Gallbladder attack; This is a spontaneous report from a contactable consumer, patient. A 73-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) intramuscularly in the left arm on 26Jan2021 at 03:30 AM (at the age of 73-years-old) as a single dose (Batch/Lot Number: EI9262), and received the second dose intramuscularly, in the left arm on 16Feb2021 (at the age of 73-years-old) as a single dose (Batch/Lot Number: EN6201), for COVID-19 immunisation . Medical history included Penicillin allergy from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included hydrochlorothiazide/ramipril (RAMIPRIL HCTZ). About a week after both Covid-19 vaccine injections, the patient experienced chills, fatigue, severe abdominal cramping, and gallbladder attack. The patient stated that the chills and fatigue, were expected, but she had severe abdominal cramping and what appeared to be a gallbladder attack. The patient did not have a sore arm or fever. No treatment was received for the events. The patient recovered from the events, chills, fatigue, severe abdominal cramping, and gallbladder attack.
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| 73 | 2021-03-25 | diarrhea |
Pfizer-BioNTec Covid 19 Vaccine EUA; Diarrhea began 6 days after first vaccine February 4th throu...
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Pfizer-BioNTec Covid 19 Vaccine EUA; Diarrhea began 6 days after first vaccine February 4th through February 14th. Diarrhea began 1 day after second vaccine dose on February 18th and is still present March 26. Took Immodium 3 different times as it worsened from doctors instructions. Had some relief, but it keeps returning.
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| 73 | 2021-03-25 | difficulty swallowing | Pt c/o lump in throat, difficulty swallowing. VSS. Transported to ED for further observation. |
| 73 | 2021-03-26 | indigestion, vomiting | Had heartburn for 3 days (in addition to incredible chills, dizzy. Vomiting) |
| 73 | 2021-03-26 | vomiting |
After 12 hrs. neuropathy in feet and torso, shortness of breath, chest tightness continued for 3 day...
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After 12 hrs. neuropathy in feet and torso, shortness of breath, chest tightness continued for 3 days went to urgent care checked out OK but symptoms persist to this day. On 3/13 severe dizziness and vomiting and blacking out and went to ER. Admitted overnight. Pulmonologist prescribed course of Prednisone on 3/15 and ending on 3/25. Some relief for chest tightness Neuropathy has gotten steadily worse with inclusion of face and lower leg. On 4th day began some ringing in ears which is to this day louder. Have fatiugue, sleep issues, trouble focusing my brain and eyes. Everything is worse today. Can't hold my head up. Will someone please help me
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| 73 | 2021-03-27 | flatulence | Gas pain, 1/10 tenderness RUQ 156/80, 80 16 O2 sat 98% |
| 73 | 2021-03-30 | nausea |
She was been down for over a week, the Covid symptoms; weakness of bones; nauseous; headaches; she m...
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She was been down for over a week, the Covid symptoms; weakness of bones; nauseous; headaches; she missed the 2nd dose; Tested positive for COVID; Tested positive for COVID; sick; This is a spontaneous report from a Pfizer Sponsored Program. Two contactable consumers (patient's husband and patient herself) reported that a 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in Arm Left on 07Feb2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 14Mar2021, the patient tested positive for COVID, sick, she missed the 2nd dose, weakness of bones, nauseous, headaches, serious side effects and she was been down for over a week, the COVID symptoms on an unspecified date. He does not have any adverse reaction at all. The report was received as, he does not have any adverse reaction at all. The reason for call is not for him personally. It is for his fiance. For the first dose, he had his dose on 14Mar2021. Prior to that first dose, 3 weeks before that, is when he had first dose. She and him went together for first dose. She has one dose and had to go back to her hometown for a family emergency and was not able to go for second dose. In the interim, she got a COVID test and she tested positive. She did not come for second shot or they would have gone together. What does she have to do after testing positive and missing her second dose? He was going to have her call directly. He said she has all the information about what they used and what protocol for test she took. Reporter stated, "Well I have a situation. My wife and I on 7Feb2021 got our 1st dose. In the interim she had to go out of town to her family and she tested positive after her 1st dose. My question is, I went and had my 2nd dose on 14Mar2021. I got mine, but she didn't get hers. She would like to know, how long she had wait before she gets the 2nd dose." Reporter stated, "Since I have you on the phone you can get the side effects. She had serious side effects. She was been down for over a week, the Covid symptoms. She is not asthmatic. She had weakness of bones, nauseous, headaches no fever or coughs but all the other symptoms." She may be taking thyroid medications. That's all I know. Reporter stated, "I hope I don't have to go on hold for another 2 hours and 45 minutes." The doctor's don't know. She is recovering. I already spoke with the safety team and reported this.: Spoke from attached document and emailed as requested Spoke from (LAB- 1457-6.0 Revised: 25Feb2021) under section 18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA "The study excluded participants who were immunocompromised and those who had previous clinical or microbiological diagnosis of COVID-19." Therapeutic measures were taken as a result of she was been down for over a week, the COVID symptoms, sick, weakness of bones, nauseous, headaches and serious side effects with reported as, she is taking some vitamins. The patient underwent lab tests and procedures which included COVID-19 test: positive on 14Mar2021. The outcome of events was recovering. Information on the lot/batch number has been requested.
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| 73 | 2021-03-30 | vomiting, nausea |
Nausea; Dizziness; Vomiting; Fever; This is a spontaneous report from a contactable consumer (patien...
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Nausea; Dizziness; Vomiting; Fever; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot Number: EL1283), via an unspecified route of administration on 21Jan2021 13:00 (at the age of 73-years-old) as a single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included unspecified medications. On 21Jan2021, consumer stated, "I got the Pfizer vaccine on Thursday (21Jan2021) at 13:00 and I started having at 13:23 I started having nausea and a little dizziness and then I have had nausea and vomiting twice but nausea was constant. On an unspecified date in Jan2021, the patient had fever. Consumer stated, I am kind of dizzy. So, I got to walk slow. Therapeutic measures were taken as a result of events included pepcid for nausea and Tylenol for fever. The consumer stated, "I am really having side effects. I thought it is going way. And I wanted to know how long I would have side effects." The outcome of the events was not recovered.
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| 73 | 2021-04-06 | vomiting |
Neuropathy; Shortness of breath; chest tightness; ringing in ears; fatigue; brain fog; dizziness; vo...
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Neuropathy; Shortness of breath; chest tightness; ringing in ears; fatigue; brain fog; dizziness; vomiting; vision changes; This is a spontaneous report from a contactable consumer. A 73-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot Number: EN6205), via an unspecified route of administration, administered in Arm Right on 09Mar2021 15:00 as SINGLE DOSE for covid-19 immunisation. Medical history included asthma, glaucoma, Manages cholesterol, controlled high BP and iodine contrast. The patient's concomitant medications were not reported. The patient experienced neuropathy, shortness of breath, chest tightness , ringing in ears, fatigue, brain fog, dizziness, vomiting and vision changes on 10Mar2021 03:00. The patient was hospitalized for all of the events for 2 days on an unspecified date. The patient underwent lab tests and procedures which included Nasal Swab: negative on 13Mar2021. The patient was not pregnant. Outcome of the events was not recovered.
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| 73 | 2021-04-12 | abdominal discomfort |
twelve hours after getting the shot my wife woke up with an upset stomach; her blood sugar was also ...
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twelve hours after getting the shot my wife woke up with an upset stomach; her blood sugar was also slightly elevated; within ~the next two hours she became disoriented and confused; I called 911 and within a couple of minutes of the first 911 call she stopped breathing and could not be revived.
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| 73 | 2021-04-12 | abdominal pain upper |
Started experiencing wheezing and shortness of breath and reduction of oxygen level below 90 prior t...
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Started experiencing wheezing and shortness of breath and reduction of oxygen level below 90 prior to entering the ER on Sunday, March 21, 2021. Noticed particular shortness of breath Saturday before entering ER. Oxygen levels ran between 92 and as low as 87 that Saturday afternoon and Sunday morning. Also had severe stomach pain which was determined to be caused by gall bladder stone.
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| 73 | 2021-04-12 | abdominal pain |
Death Abdominal pain Abnormal CT scan Partial gastric outlet obstruction Disorder of common bile du...
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Death Abdominal pain Abnormal CT scan Partial gastric outlet obstruction Disorder of common bile duct Hyperbilirubinemia Colon cancer (CMS/HCC) Obstructive jaundice
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| 73 | 2021-04-13 | abdominal pain |
Pt c/o abdominal pain that began 5 min after vaccine administration, per pt's son. Pt main complaint...
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Pt c/o abdominal pain that began 5 min after vaccine administration, per pt's son. Pt main complaint in the ED was abdominal pain. On exam pt's abdomen was tender diffusely. Within minutes of initial evaluation the pt lost consciousness. Minutes later the pt was apneic and pulseless. Resuscitative efforts were initiated per ACLS protocol. During resuscitative efforts the pt received several rounds of code-dosed epinephrine. In addition, the pt received 1 dose of IV Benadryl in addition to medications standard for ACLS protocol. Benadryl was administered specifically to treat the possibility of anaphylaxis.
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| 73 | 2021-04-18 | abdominal pain upper |
After the first shot, pancreatitis set in then her gallbladder was removed. She had severe stomach p...
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After the first shot, pancreatitis set in then her gallbladder was removed. She had severe stomach pain. Things calmed down then two days after second shot the pain started back up. She was hospitalized for 20 days. Skin had sores all over it and puss was coming out of the sores. Her body swelled up like a balloon. She then had to go to a rehab center to get her strength back to walk and move.
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| 73 | 2021-04-28 | decreased appetite, vomiting, nausea |
didn't eat or drink much of anything/couldn't eat or drink; She was probably dehydrated; GFR of 52; ...
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didn't eat or drink much of anything/couldn't eat or drink; She was probably dehydrated; GFR of 52; blood pressure 82/50; skin tenting; dizziness/orthostatic dizziness/dizzy; Nausea vomiting; Nausea vomiting; chills and cold sweats; chills and cold sweats/all sweaty, cold; felt blah; sore arm after 2nd dose; This is a spontaneous report from a contactable nurse reporting for herself. A 73-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP7533), via an unspecified route of administration, administered in arm left on 07Apr2021 at 13:30 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously received BNT162B2 on 16Mar2021 (at the age of 73-years-old) for COVID-19 immunisation and experienced Sore arm and feeling blah. Clinical course was as follows: She spent 50 years in neurology and neuroscience, she was a crazy RN that did neurology right out of school, she was recommended for that specialty. She is not sure if she had a reaction to the vaccine or if it is just her. Her 2nd dose was last Wednesday, 07Apr2021. She had a sore arm and felt blah. Just like after the 1st shot. On Saturday night (10Apr2021) at 0200, she was awakened with chills, cold sweat, dizziness, nausea and vomiting. She was sick as a dog for 2 days and didn't eat or drink much of anything. She went to the doctor who sent her to an infusion center. She is down to 5' 2" and weighed too much. She has not been able to lose weight for a couple years. She gained 40 pounds when she turned 50 years old. After the shot, she had a sore arm and felt blah like she did after the first dose, but she thought everyone felt that way. She missed a day of gym class because of her really sore arm. This got better like after a flu shot, it was nothing. This time she had a really sore arm and felt blah after the shot but then on Saturday morning this whole thing started happening. She woke up very restless, was all sweaty, cold, dizzy and was too miserable to try and take her blood pressure. Her blood pressure tends to run low. Her symptoms of the sore arm resolved at 06:00 Saturday (08Apr2021). She had nausea and vomiting and couldn't eat or drink. That lasted through Monday morning. She had some back pain with this, but she has back pain normally as she is a little old lady. She had a scheduled Oncology appointment Monday, as did her husband. She experienced orthostatic dizziness. She woke up plain dizzy. Her doctor gave her a liter of fluids and it helped her. This was something that needed to be addressed. It was serious. It was all serious. She had nothing left to vomit. She is an old lady with Breast Cancer. Her creatinine level of 1.10 which dropped her GFR of 52, she calculated the GFR using a computer program. This is what lead to the doctor giving her a liter of fluid. She had an appointment scheduled and her doctor sent her to the infusion centers for a liter of D5NS. She was sent home afterwards and encouraged to drink fluids. She also had a CBC and chemistry panel with her blood work. She was worried because her skin was tenting badly, and she couldn't keep anything down. She was probably dehydrated. Her blood pressure at the doctor's office was 82/50. She didn't care that her skin was tenting. She has been drinking a lot of fluids as advised after her liter of fluids at the infusion center. She is interested in researching the MRNA process because it is used it in other things. The way the vaccine was developed, it should have dissipated after 48 hours. She likes to research everything. She and her husband experienced a year from Hell starting in August of last year. All events are considered serious. The patient underwent lab tests and procedures which included blood creatinine: 1.10 and blood pressure measurement: 82/50 on 12Apr2021, blood test, full blood count and investigation with unknown results and glomerular filtration rate: 52 on an unspecified date. The outcome of the events chills and cold sweat was recovered on 12Apr2021, skin tenting and orthostatic dizziness was recovered on 13Apr2021, vomiting and nausea was recovered on 14Apr2021, pain in arm was recovered on 10Apr2021, feeling abnormal was recovered on an unspecified date, while of the rest was unknown.; Sender's Comments: Based on a temporal association and the known drug safety profile, the reported events are considered possibly related to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 74 | 2020-12-31 | decreased appetite | Lethargic, not eating |
| 74 | 2021-01-05 | vomiting, diarrhea |
Headache, sore arm, vomiting, diarrhea, chills Took injection @ approx. 10:45 am on 1/4/21; symptom...
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Headache, sore arm, vomiting, diarrhea, chills Took injection @ approx. 10:45 am on 1/4/21; symptoms started about 3:30pm and lasted from 6-8 hrs. Headache & sore arm lingering on 1/6/21.
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| 74 | 2021-01-09 | abdominal pain upper, diarrhea | Gastric pain Diarrhea |
| 74 | 2021-01-10 | nausea | Lightheaded, nausea Outcome -> signs & symptoms form submitted for COVID test |
| 74 | 2021-01-11 | vomiting, diarrhea |
Headache; Sore arm; Vomiting; Diarrhea; Chills; This is a spontaneous report from a contactable cons...
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Headache; Sore arm; Vomiting; Diarrhea; Chills; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female (non-pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ELO142), via an unspecified route of administration in left arm, on 04Jan2021 at 10:45, at a single dose, for COVID-19 immunization. The patient's medical history included arrhythmia, right shoulder reverse replacement, and fusion at L5S4. The patient's concomitant medications included metoprolol tartrate, digoxin, levothyroxine, and montelukast sodium (MONTEL). The patient previously took codeine and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered in a hospital. On 04Jan2021 at 3:30 PM, the patient experienced headache, sore arm, vomiting, diarrhea, and chills. The events were considered non-serious. No treatment received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events in Jan2021.
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| 74 | 2021-01-12 | nausea |
Got really sick overnight; Headache; Chills; Body aches; Nausea; Joints hurt; This is a spontaneous ...
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Got really sick overnight; Headache; Chills; Body aches; Nausea; Joints hurt; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EH9899), via an unspecified route of administration on 04Jan2021 (at the age of 74-years-old) as a single dose for COVID-19 vaccination. Medical history included thyroid disorder. Concomitant medications included levothyroxine from an unknown date at 100 (units not provided) for thyroid. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number unknown) on an unknown date (at the age of 74-years-old) as a single dose for COVID-19 vaccination. After the patient received the second BNT162B2 vaccine dose, overnight the patient got really sick, the patient experienced headache, chills, body aches, nausea, and joints hurt, all on unknown dates in Jan2021, per the patient it started during the night. The patient received ibuprofen (ADVIL) as treatment for the events. The clinical outcome of got really sick overnight and chills were unknown and the outcome of the events headache, body aches, nausea, and joints hurt was not recovered. It was also reported that the patient has been tested for COVID-19 with unknown results, the patient stated they get a COVID test every week at work.
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| 74 | 2021-01-13 | vomiting |
very weak and sleepy; very weak and sleepy; Vomiting; Shivers; had gotten sick; Pain injection site;...
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very weak and sleepy; very weak and sleepy; Vomiting; Shivers; had gotten sick; Pain injection site; This is a spontaneous report from a contactable consumer. A 74-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot EL3246, expiry date not reported), intramuscular on 05Jan2021 13:30 at a single dose in the upper left arm for COVID-19 prophylaxis. There were no medical history and concomitant medications. Patient had no prior vaccinations (within 4 weeks). Patient asked if there was any contraindication to getting the second dose. Patient reported having vomiting and shivers the day after receiving the vaccine as well as pain at injection site which was reportedly now resolved. Patient was calling about the Covid-19 vaccine and reported that she received the vaccine this past Tuesday 05Jan2021. She said that she was very sick the next day (06Jan2021). She said that 5 people went with her to get the vaccine and she was the only one who had gotten sick. Patient clarified that she had vomiting throughout the day the next day after receiving the vaccine. She also reported that she had shivers for hours and hours. She said that she had blankets and quilts on her and she could not stop shivering. She said that when she went to the doctor, the doctor thought it was because of the vaccine. Patient wanted to know if she should she take the second shot and if these will happen to her again or not and asked if there are any contraindications. She said that the vomiting started in the morning around 10:00 on 06Jan2021. It lasted a couple of hours until about 13:00 06Jan2021. She said that the shivers were bad, and she had big time shivering and there was nothing she could do to stop the shivering. The shivering lasted from 10:00 06Jan2021 until about 5-6 in the evening 06Jan2021. As the day progressed the pain where they gave her the shot was very bad on 05Jan2021. She said that she had pain at the injection site (pain injection site) on 05Jan2021. She said that it only hurts now if she touches the area. She said that the site previously it hurt without touching it. Patient was very weak and sleepy the next day. She said that she felt very weak and sleepy on 07Jan2021. She said that it lasted throughout the entirety of the day and she fell asleep and felt better today (at the time of the report). She said that today she felt fine. The events did not require emergency room visit but events required physician's office visit. The events were reported as not serious. Therapeutic measures were taken as a result of the events weak and sleepy. The patient recovered from vomiting on 06Jan2021 13:00, from shivers on 06Jan2021, from weak and sleepy on 07Jan2021. The patient was recovering from pain injection site. The outcome of the event sick was unknown.
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| 74 | 2021-01-14 | decreased appetite |
Resident had severe confusion. She thought she was in another state and that we were all strangers. ...
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Resident had severe confusion. She thought she was in another state and that we were all strangers. She has a decrease in her appetite and an increase in thirst. She complained of low back pain with aches all over her body. She also stated that she had very vivid dreams. this is not at all the typical behavior that we have seen in her. Previous labs were checked and all were within normal range.
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| 74 | 2021-01-14 | nausea |
fevers of 101; getting worse; she is so sick; felt 'nausea, chilly and hot'/she is feeling hot; fel...
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fevers of 101; getting worse; she is so sick; felt 'nausea, chilly and hot'/she is feeling hot; felt 'nausea, chilly and hot'/nauseous; arm been sore; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 05Jan2021 09:30 at single dose for prevention. Medical history included covid-19 from Jul2020, hair loss. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fevers of 101 on an unspecified date with outcome of unknown, felt 'nausea, chilly and hot'/nauseous on 08Jan2021 with outcome of not recovered, felt 'nausea, chilly and hot'/she was feeling hot on 08Jan2021 13:00 with outcome of not recovered, getting worse on an unspecified date with outcome of unknown, arm been sore on 06Jan2021 08:00 and on 08Jan2021 08:00 with outcome of not recovered, she was so sick on an unspecified date with outcome of unknown. Clinical course: She had it on Tuesday and arm been sore since then. now she gotten very nauseous. Her temperature is around 98 degrees Fahrenheit now and she is feeling hot. She does not have a temperature. After transfer caller stated ' I felt nauseous but now its gone, but also getting worse.' She was usually 96 or 97 degrees Fahrenheit. She was nauseous. Is this normal after 4 days. There was no prescriber. She was more sore on Wednesday than she is now. It is better yesterday and now than on Wednesday when it was real sore. She did something she should not have done. She went to a yoga class and had not eaten. Afterwards, she had a strawberry and did not feel like eating. Then she said she did not take her pills, which are mostly vitamins. The thought of taking pills made her sick. After she took them she ate something and has been nauseous ever since. She did not confirm if she needed glasses prior to getting the vaccine. She had COVID in Jul2020. She is taking a lot of vitamins. She had hair loss and is taking Biotin. She takes very few prescribed medications. Now she was so sick she would not think of taking them. No further details provided. The patient underwent lab tests and procedures which included body temperature: 98 degrees fahrenheit on unknown date. Information on the Lot/batch number has been requested.
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| 74 | 2021-01-18 | nausea, vomiting, diarrhea |
Nausea; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer reporting for h...
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Nausea; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer reporting for herself. A 74-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: 409017123), via an unspecified route of administration on 08Jan2021 09:30 at SINGLE DOSE (first dose, upper arm right) for COVID-19 immunization. Medical history reported as none. The patient did not have prior vaccinations within 4 weeks. No family medical history and no relevant tests. There were no concomitant medications. On 08Jan2021, the patient experienced diarrhea first at 11:00, an hour and a half after vaccination. Nausea and vomiting began an hour after diarrhea started at 12:00. Adverse events did not require visit to physician. The patient was advised by the physician office to self-treat with sips of water and bland food. Outcome of the events was unknown.
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| 74 | 2021-01-21 | vomiting, nausea, decreased appetite |
Day 1 - nothing Day 2 - nausea (mild progressing to severe), vomiting (x2),...
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Day 1 - nothing Day 2 - nausea (mild progressing to severe), vomiting (x2), dull headache, no appetite, fatigue, chills (on/off) Day 3 - nausea (moderate), Pancreatitis-like symptoms (lasted 1 day), no appetite, fatigue, erratic blood sugars, chills (on/off) Day 4 - fatigue, chills (on/off), no appetite, generally feeling unwell. Day 5 and continuing, generally not feeling well, no appetite, chills (on/off) NO FEVER AT ANY TIME
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| 74 | 2021-01-24 | diarrhea, decreased appetite |
Developed hives on my face, on my head, on top of my back and they also itch in addition to the all ...
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Developed hives on my face, on my head, on top of my back and they also itch in addition to the all over itching; headaches; Pain around my face, my left arm; Developed severe itching from head to toe; I was running a temperature of 102; I could not even sit on the side of bed without falling to one side or the other or falling backwards so very weak and unable to move; I could not even sit on the side of bed without falling to one side or the other or falling backwards so very weak and unable to move; Appetite lost; Chills; soreness more than usual from the shot; Soreness in my arm, my neck; Soreness in my arm, my neck/ pain around her face, her left arm; I got stiff neck, my back, my lower back; Massive weakness; Confusion; terrible sleepiness; Diarrhea; I still don't feel good; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received her second single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot EL3248, expiration Apr2021) at 6:00AM on 07Jan2021 for Covid-19 immunization. The patient had her first dose on 19Dec2020 and had side effects from it but very few. The patient was worked at COVID rooms to clean rooms in hospital as a housekeeper and so her exposer to the hospital made her in first group to get the vaccine. Medical history included allergies (had anaphylactic shock from Amoxicillin and from Tylenol, she cannot take Tylenol), anxiety, and high blood pressure. Concomitant medications included acetylsalicylic acid (ASPIRIN) on regular basis, bisoprolol fumarate, loratadine (CLARITIN) for allergies, escitalopram for anxiety, mometasone furoate (FLONASE) for allergies, losartan, magnesium, omeprazole, and triamterene. On the first day (07Jan2021) she had soreness more than usual from the shot, soreness in her arm, her neck. She got stiff neck, back, lower back. She had gotten the shot at 6 am, then worked at that time and by the time she got home at noon, she had massive weakness, some confusion, terrible sleepiness and by evening, she developed diarrhea. On the second day (08Jan2021) the pain increased the weakness increased, and she was running a temperature of 102. She could not even sit on the side of bed without falling to one side or the other or falling backwards so very weak and unable to move pretty much. She could not eat and lost appetite, and she developed the chills on that evening. On the third day (09Jan2021) she was running a temperature of 101 so it had gone down. She still had headaches, and pain around her face, her left arm and developed severe itching from head to toe, and on the next day (10Jan2021) she developed hives on her face, on her head, on top of her back and they also itch in addition to the all over itching. The temperature was gone, she had no temperature when she developed the hives. At the report day, she stated that she had not gone back to work as she broke out in the horrible hives and she still did not feel good. Only cold ice packs on the hives/ itching and no more treatment received for the events. The fever and itching resolved on 10Jan2021, and outcome of all other events was unknown.
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| 74 | 2021-01-25 | diarrhea | Diarrhea |
| 74 | 2021-01-25 | diarrhea |
Headache, chills, diarrhea for 5 days, then better for a day, then it started again to a lesser ext...
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Headache, chills, diarrhea for 5 days, then better for a day, then it started again to a lesser extent. Now 11 days out I am better. Sometimes have mild headache.
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| 74 | 2021-01-25 | nausea, vomiting |
Initially soreness around injection site later followed by vertigo, nausea and vomiting. which reso...
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Initially soreness around injection site later followed by vertigo, nausea and vomiting. which resolved after 48 hours. Dizziness continued and on fourth day I developed body aches, low grade fever (100.9) and nausea. which lasted for three days.
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| 74 | 2021-01-26 | decreased appetite |
Severe headache; tiredness; muscle pain; chills; fever 99.7; joint pain; feeling unwell; cough; no a...
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Severe headache; tiredness; muscle pain; chills; fever 99.7; joint pain; feeling unwell; cough; no appetite; This is a spontaneous report from a contactable consumer reported for self. This 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3246) via unspecified route of administration at 08Jan2021 10:30 AM at single dose in right arm for COVID-19 immunization. The patient is not pregnant. The age at vaccination is reported as 74 years old. The patient medical history and concomitant medications were not reported. The patient previously received benzoin and experienced allergy. The patient experienced severe headache, tiredness, muscle pain, chills, fever 99.7, joint pain, feeling unwell, cough, no appetite at 15Jan2021 18:00 PM. The events are reported as non-serious by reporter. The patient received no treatment. The patient was not diagnosed with COVID-19 prior to and since the vaccination. The patient was recovering from the events.
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| 74 | 2021-01-27 | decreased appetite |
Shallow breath with spastic cough On again off again fever and chills Headaches Fatigue, lethargic, ...
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Shallow breath with spastic cough On again off again fever and chills Headaches Fatigue, lethargic, not able to do much No appetite Urine strong odor, different color, and frequent Cramping in hands and feey
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| 74 | 2021-01-27 | diarrhea, nausea |
Hives/Rash. Various places on my arms, legs, neck, vaginal area. Itchy. Took Benadryl even 6 hours. ...
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Hives/Rash. Various places on my arms, legs, neck, vaginal area. Itchy. Took Benadryl even 6 hours. Lasted 3 days Tingling in arm in the exact area shot was given started on 3 day after injection. Nausea and diarrhea started on 3rd day after injection
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| 74 | 2021-01-27 | diarrhea | diarrhea |
| 74 | 2021-01-27 | difficulty swallowing |
Pain (level 4 of 10) starting in right rear of neck, becoming more intense on 01/19/21. By evening h...
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Pain (level 4 of 10) starting in right rear of neck, becoming more intense on 01/19/21. By evening head movement was very difficult, I could not sleep in bed that night. I slept on the couch sitting up trying to immobilize head. During the night pain spread into the base of my skull. I applied heat to help relieve the pain and tightness. On 01/20/21 the pain (6 of 10) spread into the left side of neck and skull, it became difficult to eat, swallow and to get up from couch. I tried to sit motionless most of the day. On 01/21/21 the pain (6 of !0) moved down into my left rear shoulder, I continued to apply heat and immobilize sitting on couch, eating and swallowing still difficult. On 01/22/21 pain in neck and base of Additional information for Item 18: skull subside to level 5, movement of head still difficult, able to to get up and move slowly. Could not lift head to drink, still needed to use straw. Slept on couch again this night. On 01/23/21 pain still subsiding to level 4, head movement still difficult, still needed straw to drink, slept on couch again. On 01/24/21 pain continuing to subside to level 3, head movement still difficult, still needed straw to drink, slept on couch again. On 01/25/21 conditions unchanged. On 1/26/21 pain subsided to level 2, head movement stiff but not difficult, swallowing less difficult but still need straw to drink. Slept in bed for first time since 01/19/21. On 01/27/21 pain continued to subside to level 1, head movement improved but still limited, still need straw to drink, able to move around more freely but still not normal. Improvement is slow but I hope to be back to normal in a few days. I am concerned that my second vaccination may cause a more severe reaction, please have someone call or contact me so I can discuss this issue.
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| 74 | 2021-01-27 | nausea, vomiting |
Presented to ED with dizziness and nausea and vomiting and SOB. Na level of 111 (1/27); Cl 82; CO2 1...
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Presented to ED with dizziness and nausea and vomiting and SOB. Na level of 111 (1/27); Cl 82; CO2 17 All other BMP labs WNL. Urine Osmolality 436; urine sodium 89. Admitted to hospital for treatment. Nephrologist states that she has not prior history of hyponatremia (12/1/20 Na was 139)
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| 74 | 2021-01-28 | diarrhea |
Severe urgent diarrhea; Feels like she might be getting a little fever; This is a spontaneous report...
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Severe urgent diarrhea; Feels like she might be getting a little fever; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date unknown), via an unspecified route of administration to right deltoid (shoulder) on 15Jan2021 at around 10:30-10:40 AM at a single dose for COVID-19 immunization. Medical history included chronic fatigue syndrome, fibromyalgia, problems with her colon, back surgery, and flashes. Concomitant medications included ibuprofen given on unspecified date for back surgery, and unspecified hormones, vitamins, and laxatives. The patient previously received the flu vaccine on unspecified date and experienced like she got the flu and relapse of her chronic fatigue syndrome. She also received hepatitis C vaccine, hepatitis B vaccine, pneumonia vaccine, and shingles vaccine; all on unspecified dates. The patient had not received prior vaccinations within four weeks. On 15Jan2021, the patient experienced severe urgent diarrhea and felt like she might be getting a little fever. It was further described as: Patient had an odd reaction within maybe 30 minutes to 1 hour after that dose was administered of severe urgent diarrhea. Patient mentioned she felt like she might be getting a little fever; but she was not sure and did not have a thermometer to check that. Severe urgent diarrhea: She mentioned she had not seen that side effect posted anywhere for the vaccine so she felt it was an odd reaction; although she did see that it was a side effect of the virus, so maybe it was not that odd of a reaction for the vaccine now that she thought about it. She described this event as completely crazy, the urgency to go to the bathroom, she almost did not make it home to the bathroom. It just hit her like she has never experienced before. It cleaned out her colon really well. She also felt like she might be getting a little fever but mentioned that at her age she gets hormone flashes so it could be that; and was humid at the time of report and thought so it could just be from that. The outcome of the events was unknown. Information regarding Batch/ Lot number has been requested.
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| 74 | 2021-01-28 | nausea |
Significant left-arm pain, fatigue, general muscle ache, nausea, headache, chills Began 12 hours aft...
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Significant left-arm pain, fatigue, general muscle ache, nausea, headache, chills Began 12 hours after vaccination Symptoms still present, but beginning to improve after 48 hours
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| 74 | 2021-01-30 | nausea |
Next day: fever 100.2 Muscle aches, joint pain, nausea, fatigues, head ache all day thru early eveni...
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Next day: fever 100.2 Muscle aches, joint pain, nausea, fatigues, head ache all day thru early evening Day 2: no fever, joint pain, muscle aches, head ache and nausea all less then day before
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| 74 | 2021-01-31 | decreased appetite |
Two hours after the vaccine I had heart palpitations, my lips were tingling and I felt fatigue and a...
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Two hours after the vaccine I had heart palpitations, my lips were tingling and I felt fatigue and appetite loss. This lasted about 30 minutes. 36 hours after vaccine I experienced headache, swollen tender left lymph node above collarbone and elevated BP 167/90. This improved after taking Advil.
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| 74 | 2021-01-31 | decreased appetite |
Constant headache fever ( 99.7) chills achy muscles no appetite Feeling somewhat better 48 hours lat...
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Constant headache fever ( 99.7) chills achy muscles no appetite Feeling somewhat better 48 hours later -- but not all better
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| 74 | 2021-02-01 | diarrhea, nausea, vomiting |
Day 1-3 severe chills, severe headache, tired, joint pain/body aches, temp >101 Day 3-6 or 7 sore th...
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Day 1-3 severe chills, severe headache, tired, joint pain/body aches, temp >101 Day 3-6 or 7 sore throat, nausea, vomiting, diarrhea, altered taste Also complaint of intermittent acute shortness of breath and cough
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| 74 | 2021-02-01 | nausea, vomiting |
Throwing up; She feels nausea; still feels woozy; This is a spontaneous report from a contactable co...
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Throwing up; She feels nausea; still feels woozy; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), via an unspecified route of administration on 19Jan2021 at 09:11 at a single dose in the left arm for COVID-19 immunization. The patient's medical history included ongoing nose has been running, ongoing diabetes mellitus, and sinus infection. Concomitant medication included an unspecified every day medicine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient got the shot on 19Jan2021. On the same day, when she came home, she has been throwing up for the last 30-40 minutes. It was like it came on all of a sudden. She feels nausea and still feels woozy. This was her first dose. She is scheduled to get the second dose on 10Feb2021. She wanted to know what she should do. The outcome of the events was unknown.
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| 74 | 2021-02-02 | decreased appetite |
The evening of shot #2 on 1/29/21, I got a fever of 100.4. Had serious chills, took hot baths, slept...
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The evening of shot #2 on 1/29/21, I got a fever of 100.4. Had serious chills, took hot baths, slept fitfully. Felt tired. Fever continued until 5 pm the next day (Saturday). Didn?t eat much. Fever broke late afternoon on 1/30 and I felt better. Slept better. But was very, very tired the next two days (1/31 and 2/1). Felt normal the 4th day, 2/2. My first shot was on 1/12/21 and I had no reaction other than a sore arm. For 24 hours.
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| 74 | 2021-02-02 | nausea, vomiting | Nausea, vomiting, Temp over 100, extremely weak, head ache |
| 74 | 2021-02-02 | nausea |
Was fine the day of receiving vaccine. The next morning when woke up, was unable to move legs. State...
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Was fine the day of receiving vaccine. The next morning when woke up, was unable to move legs. Stated could not get out of bed, could not walk, has severe weakness. flank pain, nausea, headache, fever, and chills
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| 74 | 2021-02-03 | difficulty swallowing |
Trouble swallowing, expelling mucus, tongue swelling, shortness of breath. Epi administered IM in r...
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Trouble swallowing, expelling mucus, tongue swelling, shortness of breath. Epi administered IM in right thigh. Patient sent via ambulance to hopsital.
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| 74 | 2021-02-04 | difficulty swallowing |
Pfizer-BioNTech COVID-19 Vaccine EUA drive thru vaccination clinic - Patient with complex medical h...
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Pfizer-BioNTech COVID-19 Vaccine EUA drive thru vaccination clinic - Patient with complex medical history including multiple allergies experienced reaction within minutes of receiving dose #1. Premedicated with benadryl and sublingual allergy med. Reaction include tingling and numbness with thickness of tongue, difficulty swallowing and chest tightness. She has NTG but has never had to use. 911 called and patient brought to ED. Seen and discharged after patient felt better.
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| 74 | 2021-02-04 | nausea |
Within 15-minutes of vaccination, the patient reported feeling lightheaded and nauseous. Patient was...
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Within 15-minutes of vaccination, the patient reported feeling lightheaded and nauseous. Patient was found to hypertensive (170/88) compared to baseline hypotension. Patient was evaluated for 20-minutes and her vitals and mentation returned to normal. The patient refused transport and was able to ambulate to her daughter's car.
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| 74 | 2021-02-07 | diarrhea, nausea |
12 hours after SECOND Pfizer covid: Fever 104; chills, body aches, nausea, headache, severe body ac...
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12 hours after SECOND Pfizer covid: Fever 104; chills, body aches, nausea, headache, severe body ache, for 48 hours, then fever subsided and diarrhea and cold-like symptoms set in.
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| 74 | 2021-02-07 | nausea |
Start of an ear infection; Stuffy nose; Sore throat; Headache; Muscle and joint pain; Muscle and joi...
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Start of an ear infection; Stuffy nose; Sore throat; Headache; Muscle and joint pain; Muscle and joint pain; Chills; Dry mouth; White coating all over tongue; Nausea; Unbelievable thirst; Slight swelling at injection site; Injection site pain; Tiredness; swollen tonsils; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EL1283), via an unspecified route of administration in the right arm on 13Jan2021 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included Transverse Myelitis ongoing from 2016, neurologic lime disease ongoing from 1992 due to which the patient gets migraines (from 1992), H. Pylori in May2019 and the patient is hard of hearing, ongoing from an unknown date. The patient's concomitant medications included unspecified migraine medication. On 13Jan2021 the patient experienced injection site pain, slight swelling at injection site, tiredness, and unbelievable thirst. On 14Jan2021 the patient experienced headache, muscle and joint pain, chills (which come and go), nausea (which is off and on), dry mouth, and white coating all over tongue. On 15Jan2021 the patient experienced stuffy nose and sore throat. The patient stated she still has tonsils on her right side where she has the earache and they are swollen (from an unknown date in Jan2021). On 17Jan2021 the patient experienced start of an ear infection (earache on the right side). The patient has had no fever and no redness. The patient stated she knows injection site pain is standard for a lot of people. The patient stated on Monday, 18Jan2021 she saw her provider and went over some of this. She stated she would not think that 4 days later she would still be feeling the side effects. The patient was inquiring if this only occurs with the first dose or will it also occur with the second? She is scheduled for the second one on 05Feb2021. The patient asked what was the time frame between injections? The patient was treated for the ear infection Neomycin/Polymyxin Sulfate ear drops and for the tiredness she has been walking around and trying light exercises. The patient turned down other medication as she did not want it to have any effect with the vaccine. The patient asked if there were any recommendations for the nausea and headaches. She stated she does have her migraine medication which she is trying to use to deal with the headaches. The clinical outcome of the injection site pain and slight swelling at injection site was recovered on 14Jan2021 and the white coating all over tongue recovered on 18Jan2021. The clinical outcome of the tiredness and start of an ear infection was recovering. The clinical outcome of the headache, muscle and joint pain, chills, nausea, stuffy nose, sore throat, thirst, and dry mouth was not recovered. The clinical outcome of the swollen tonsils was unknown.
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| 74 | 2021-02-07 | nausea |
At 3:30 am after receiving the vaccine the day before at about 11 am, woke up with chills, low-grade...
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At 3:30 am after receiving the vaccine the day before at about 11 am, woke up with chills, low-grade fever (99.4 when normal temperature is in low 97s). Also had a fairly bad headache, a fast heartbeat of up to 111, hips and legs ached, and felt a bit nauseated. At about 9 am took 1 extra-strenghth Tylenol, with little help. At 1 pm took 2nd Tylenol and all symptoms were pretty much gone by 3 pm in the afternoon.
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| 74 | 2021-02-08 | difficulty swallowing |
about 2 hours after shot my throat felt like it was closing and had a hard time swallowing. lasted ...
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about 2 hours after shot my throat felt like it was closing and had a hard time swallowing. lasted only until the next day. Arm was sore.
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| 74 | 2021-02-08 | nausea, diarrhea |
Diagnosed with sixth nerve palsy; Diarrhea; Headache; Nausea; This is a spontaneous report from a co...
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Diagnosed with sixth nerve palsy; Diarrhea; Headache; Nausea; This is a spontaneous report from a contactable consumer. A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686 and expiry date: Mar2021), via an unspecified route of administration on 02Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included hypertension. Concomitant medication included cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]), calcium (CALCIUM), rosuvastatin (ROSUVASTATIN). The patient experienced double vision and diagnosed with sixth nerve palsy on Jan2021, diarrhea and headache and nausea on 2021. The reporter stated "I am calling in reference to reporting possible side effect or adverse reaction to the vaccine. It is in reference to my mother, she had the first dose on 02Jan2021 and 14 days later, she started with double vision, ended up in the hospital. She was in the hospital 4 days (4 nights), diagnosed with sixth nerve palsy." The patient was hospitalization from 18Jan2021 to 22Jan2021. Reporter stated, "She was in hospital, she has visiting nurse now for physical therapy that comes to house and they going to redraw her labs tomorrow Wednesday. They were basically normal, all the lab results were normal." Therapeutic measures were taken as a result of double vision, diagnosed with sixth nerve palsy. Outcome of the events was unknown.
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| 74 | 2021-02-08 | nausea |
started with acute symptoms chills, fever, nausea. aches, and after i started to feel better and th...
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started with acute symptoms chills, fever, nausea. aches, and after i started to feel better and then full body rash from my face down my whole body.
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| 74 | 2021-02-10 | decreased appetite | pt became lethargic, stopped eating. No fever; no nausea |
| 74 | 2021-02-10 | nausea | I already did. Face itching/burning and nausea I had no red face and no discernible hives or rash. |
| 74 | 2021-02-10 | vomiting |
First I got the shot on the 3rd, that Saturday I ate breakfast and I got sick as a dog. I threw up m...
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First I got the shot on the 3rd, that Saturday I ate breakfast and I got sick as a dog. I threw up my whole breakfast. I have been throwing up every day since that day, every day and every thing I eat comes right back up. I can't keep any food in my stomach. I've got headaches, I've never had a headache in my life until I had these. The headaches are unbearable. I have not had a bowel movement since I had the virus and that's been how many days? Many. I can't sleep, I'm sick. I feel like heck, I'm scared to eat because everything I eat comes back up. I can hardly drink anything because I am diabetic, I barely drink any water. I'm a mess.
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| 74 | 2021-02-11 | flatulence, abdominal distension |
Achy whole body, abdominal area bloated/gas filled, fever of 101 deg (normal temperature runs 97.x) ...
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Achy whole body, abdominal area bloated/gas filled, fever of 101 deg (normal temperature runs 97.x) Lasted 2 1/2 days
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| 74 | 2021-02-15 | nausea |
About 15 minutes after vaccination, patient began to experience acute pyrexia and nausea. No vomiti...
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About 15 minutes after vaccination, patient began to experience acute pyrexia and nausea. No vomiting. No syncope. Vital signs within normal limits. Borderline tachy. No hypertension, but some shortness of breath and some lightheadedness.. After 1st vaccination , developed body aches and wrist burning on 2nd day. Taken to ED where BP 129/77, HR 80, O2 sat 97%. EKG showed NSR. Symptoms resolved on own.
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| 74 | 2021-02-15 | vomiting | Vomiting, weakness, difficulty walking, lasted 24 hours. Passed after sleeping 12-14 hours |
| 74 | 2021-02-16 | nausea | low fever chills aches nausea lasted 3 hours |
| 74 | 2021-02-16 | vomiting |
First night (2/12 - 2/13): chills and tremendous thirst, vomiting 2/13 : vomiting subsides through...
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First night (2/12 - 2/13): chills and tremendous thirst, vomiting 2/13 : vomiting subsides throughout the day, body aches, headache 2/13 night: shortness of breath for about 6 hours; p02 = 84. Breathing better next morning and p02 back to 96; no more vomiting
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| 74 | 2021-02-17 | nausea |
Nausea; Dizziness and room spinning; room was spinning; her white blood cell count was elevated; Kid...
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Nausea; Dizziness and room spinning; room was spinning; her white blood cell count was elevated; Kidney failure and allergic reaction; Allergic Reaction; still wasn't feeling normal; Could not keep head up and was in bed; breathless; extreme fatigue; exhausted and weak; Heart was banging fiercely; Totally dehydrated; Urinating a great deal more; Chills, shakes and felt terrible; Chills, shakes and felt terrible; sicker every single day/sick/felt terrible; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on the left arm on 18Jan2021 14:30 at a single dose for prevention for COVID. Medical history included hip replacement on 04Jan2021 and fibromyalgia (When her children were younger, she was told she had Fibromyalgia). Family history includes diabetes (father late onset) and very rare cancer (mother). There were no concomitant medications. It was reported that the patient received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine and got sick the next day (19Jan2021). She also mentioned that she got sicker every single day. Then after 8-9 days, she said she started to feel better, but still wasn't feeling normal. She said she had extreme fatigue, was breathless, and felt exhausted and weak on an unspecified date. She said she was supposed to receive the 2nd dose of the vaccine this Monday (unspecified date), but because of her side effects, she was told that she can come back to receive the 2nd dose after 6 weeks. She wants to know if this is acceptable. The patient reported that on 19Jan2021, she woke up in the middle of the night with chills, shakes, and felt terrible. She cancelled her plans for Tuesday (as reported). On Wednesday, she forced herself to get up and went out for lunch and came home. She could not keep her head up and went back to bed and that lasted several days. It got worse before it got better. She ended up being hospitalized for 4 days (25Jan2021 to 29Jan2021). It appeared to be she was in Kidney Failure and experienced allergic reaction on 25Jan2021 and her white blood cell count was elevated (unspecified date). She went to the ER and they kept her 6-8 hours and discharged her on a Friday and by Monday, she was admitted to the hospital. The first ER visit, she was there for 6-8 hours and they sent her home. They gave her IV fluids and took a lot of tests. The patient's first ER visit was on 22Jan2021, and was kept for 6-8 hours and released. She was given IV fluids and they did a lot of tests. She went to see her doctor and sent her to the emergency room. They took her blood, EKG and everything seemed ok. Creat was 1.0 and by Monday it was 1.6 and then on Friday it was 1.9 (unspecified dates). She was admitted to hospital on Monday and they gave her IV fluids and did kidney test and admitted her as soon as she could get a room. She never had a problem before with her kidneys. They did bacteria test and they were normal. The patient called her doctor on 24Jan2021, because she was nauseous, dizzy, and room was spinning and she felt worse. She went to his office on Monday morning and he put her right in the hospital (unspecified date). She got worse and now it is improved. Heart was banging fiercely on 22Jan2021 20:00. They took an Echocardiogram. She has never had a cardiac problem and could not find anything wrong with her heart. The patient started feeling a bit better. She was sick as can be through Sunday. By Tuesday (unspecified date), she was a little better and today is a little better. She is urinating a great deal more because of fluids, but later said it started the day after she got it. She had to get an aide to take care of her. The patient experienced totally dehydrated on 22Jan2021 14:00 and urinating a great deal more on 19Jan2021 03:00. Therapeutic measures were taken as a result of kidney failure, allergic reaction and white blood cell count was elevated. The outcome of the events sicker every single day/sick, chills, shakes and felt terrible was not recovered; event could not keep head up and was in bed recovered with sequel; events nausea, dizziness and room spinning, heart was banging fiercely, totally dehydrated, urinating a great deal more was recovering; while unknown for the rest of the events.
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| 74 | 2021-02-21 | difficulty swallowing |
1.Swelling, redness, pain , rash about size of silver dollar. Did not start to appear until about th...
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1.Swelling, redness, pain , rash about size of silver dollar. Did not start to appear until about the 7-8 day. Reaction continued to get worse until day 12. It is now day 15 and much improved but still present. 2. Noticed having some difficulty swallowing on the 3-4 day. Did not have problems with swallowing foods, only when trying to swallow small amounts of liquid , such as accumulated saliva. I had to consciously engage muscles to gulp or get more liquid to get it down. The problem is improved now at day 15.
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| 74 | 2021-02-21 | vomiting |
Patient began feeling extremely thirsty shortly after receiving vaccine. She stopped several times ...
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Patient began feeling extremely thirsty shortly after receiving vaccine. She stopped several times on her drive home to get bottles of water because she was so thirsty. She then vomited up the water. Symptoms resolved after several hours.
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| 74 | 2021-02-22 | abdominal discomfort | Extremely tired and aches all over. Slight upset stomach. No appetite. |
| 74 | 2021-02-22 | difficulty swallowing |
Patient finished her 15 minutes wait and made her way the vehicle. Shortly after reaching the vehic...
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Patient finished her 15 minutes wait and made her way the vehicle. Shortly after reaching the vehicle was feeling short of breath. Rapid response team from hospital came out and transported her to the emergency room. Most current nursing note as of 20 minutes ago, "pt complains of chest pains sob difficulty swallowing and weakness. pt is AA+Ox 4 and has a room air sat of 98% rr of 22, hr of 71."
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| 74 | 2021-02-22 | vomiting |
1200 pt c/o lightheaded, vomit 1203. Rapid response. NP saw pt. VS, Bp 112/82, HR 58, o2 96% RA, @...
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1200 pt c/o lightheaded, vomit 1203. Rapid response. NP saw pt. VS, Bp 112/82, HR 58, o2 96% RA, @ 1209 to ED.
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| 74 | 2021-02-23 | difficulty swallowing, nausea |
Patient had reaction to COVID-19 vaccine. Patient was monitored after COVID-19 vaccine as recommende...
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Patient had reaction to COVID-19 vaccine. Patient was monitored after COVID-19 vaccine as recommended per agency guidelines. The following reaction signs/symptoms were observed: difficulty swallowing, nausea and other : felt "woozy," felt like tongue and throat were swollen. Patient in passenger seat of car with her husband in driver's seat. Symptoms started about 5 minutes after vaccination. Pt reports that she is on BP meds for the last few months, took her BP meds today, lately BP ~120/80. She did eat lunch before coming. Called EMS due to feeling of tongue, throat swelling. EMS arrived, assessed pt, released her to home with her husband.
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| 74 | 2021-02-23 | nausea |
12 hours after injection, I got nauseated, flushed, low grade temperature, racing heart, did not sle...
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12 hours after injection, I got nauseated, flushed, low grade temperature, racing heart, did not sleep entire night.
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| 74 | 2021-02-23 | nausea | Patient complained of being lightheaded with nausea and dizziness. |
| 74 | 2021-02-23 | vomiting |
Extreme drop in blood pressure: Vaccine at 3:30 PM first drop @ 5:15 Pm to 84/51 HR 93; @ 5:50 PM 8...
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Extreme drop in blood pressure: Vaccine at 3:30 PM first drop @ 5:15 Pm to 84/51 HR 93; @ 5:50 PM 80/41 HR95; 7:00 PM 128/60 HR 50; 3:40 AM 85/46 HR 58-Irregular. This continued -the up 7 down till this writing (2/24 @ 9:30 AM). Also body aches, chills, barely able to move. No headache this time. Almost forgot - vomiting from 8:00 PM (2/23) till midnight (approx). I have vision difficulty from time of vaccination till now. I think that is all. General not feel goods!
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| 74 | 2021-02-25 | diarrhea, gastrointestinal pain | Bowel cramping & diarrhea Herpes on CHIN |
| 74 | 2021-02-25 | gastrointestinal disorder |
WEEK 1: fever, chills, headache, weakness WEEK 2: fever, chills, migraines, weakness, GI symptoms WE...
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WEEK 1: fever, chills, headache, weakness WEEK 2: fever, chills, migraines, weakness, GI symptoms WEEK 3: periodic chills, periodic headaches, weakness, periodic exhaustion, GI symptoms, elevated pancreatic enzymes WEEK 4: weakness, GI symptoms, shortness of breath, exhaustion, heart block
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| 74 | 2021-02-25 | nausea |
I had heavy chills from 6pm on the 24th until 2am on the 25th. Then, more heavy chills from 6am on ...
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I had heavy chills from 6pm on the 24th until 2am on the 25th. Then, more heavy chills from 6am on the 25th until 1 pm on the 25th. My headache was moderate but relentless throughout those days and into the 27th. I was extremely tired, having no energy or interest in doing anything but lying down. My body ached all over and I was somewhat dizzy and nauseated. I took a Tylenol during the night of the 25th. Today is the 26th and I am still very tired and my eyes are bleary.
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| 74 | 2021-02-25 | vomiting, abdominal discomfort, indigestion |
I was fine the first day. The 2nd day I wasn't feeling well, my stomach was bothering me. At 8:30 PM...
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I was fine the first day. The 2nd day I wasn't feeling well, my stomach was bothering me. At 8:30 PM I went to bed because I didn't feel good, I laid in bed for a few minutes and then jumped up because I began to violently vomit. After I vomited I felt weak, I was sitting with my back against the wall my husband came to check on me. He walked away and when he came back I was unresponsive, laying on the floor and he said my eyes rolled in the back in of head. He called 911. I was unresponsive for about a 1-2 minutes. EMS arrived, by the time they had arrived I had crawled into bed, and they took my vitals and they were fine, they asked me if I wanted to go to the hospital but I declined as I was afraid to go. I went to sleep. The next day I felt weak and tired, I had a burning feeling in my stomach, I took some TUMS, I didn't much that day. I rested most of the next day. Yesterday I felt a little better and today I am fine. I have a doctor's appointment 2/26/2021 at 2PM to see the ARNP at my doctor's office.
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| 74 | 2021-02-26 | abdominal pain upper, diarrhea, nausea |
I have been very sick to my stomach, tired, weak, shaky, nauseas, loose stool, stomach cramps, chill...
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I have been very sick to my stomach, tired, weak, shaky, nauseas, loose stool, stomach cramps, chills and an all over listless feeling that started about 18 hours after I received vaccine and still remains 4 days later
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| 74 | 2021-02-26 | gastrointestinal pain |
Had severe pain in lower intestine. Pain similar to labor pains. Difficulty evacuating. Lasted 30 m...
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Had severe pain in lower intestine. Pain similar to labor pains. Difficulty evacuating. Lasted 30 minutes or more. BM was solid at first then watery.
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| 74 | 2021-02-27 | abdominal discomfort, diarrhea |
Extremely sore arm that night; fever of 100.7, miasma, tired, chills, did not sleep; Tired all the n...
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Extremely sore arm that night; fever of 100.7, miasma, tired, chills, did not sleep; Tired all the next day with a fever at 5pm of 100.5; Sunday no temperature but loss of taste, diarrhea, stomach discomfort.
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| 74 | 2021-02-27 | vomiting, nausea | Severe headache, nausea and vomiting |
| 74 | 2021-02-28 | vomiting, nausea |
I became dizzy and then nauseous, increasingly dizzy. When I told my husband that I was getting up...
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I became dizzy and then nauseous, increasingly dizzy. When I told my husband that I was getting up to go to the restroom, perhaps to throw up, I found that I couldn't walk or make my arms and legs move in a controlled way. He helped me to a resting place on the floor. I asked him to call 911. I thought that I was having a stroke. Emergency personnel treated it as a pot overdose, because I told them that I had a bite of a pot brownie a couple of hours earlier. It was really a little piece and I doubt that it would be enough to have these results. I developed spasms throughout my body. My hands were unable to do tasks. I did throw up once at the hospital. I think that the pot issue was parallel but not necessarily the cause. I received IVs. One med was for nausea, Not sure what all. I went home about 1 AM after dizziness had lessened and spasms had stopped. Today I am a wobbly and weak, but no spasms. And I can walk and control my arms.
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| 74 | 2021-03-01 | nausea |
sweating; Chills; AFIB; Heart rate racing; Lightheadedness and dizzy and felt like she would pass ou...
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sweating; Chills; AFIB; Heart rate racing; Lightheadedness and dizzy and felt like she would pass out.; Nausea; Muscle ache; Headache; Second dose arm hurt at injection site; compromised immune status; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), intramuscular at arm left on 13Feb2021 at 10:30 (at the age of 74 years) at single dose for COVID-19 immunization. Medical history included primary biliary cholangitis (PBC, autoimmune condition and was diagnosed 10 years ago), diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, diabetes and obesity, all from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), intramuscular at arm left on 24Jan2021 and experienced sore arm. The patient experienced headache and arm hurt at injection site, both on 13Feb2021 at 19:00; heart rate racing, AFib, lightheadedness and dizzy and felt like she would pass out, all on 14Feb2021 at 07:30; nausea, muscle ache, both on 14Feb2021 at 03:00, chills on 14Feb2021 at 15:00 and sweating on 14Feb2021 at 16:00. The patient outcome of the events was recovering.
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| 74 | 2021-03-01 | vomiting, nausea |
Dizziness for two days, lightheaded ness for the next 5 days ,nausea for 5 days, vomiting, 1 day, le...
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Dizziness for two days, lightheaded ness for the next 5 days ,nausea for 5 days, vomiting, 1 day, lethargic 6 days. Unable to eat, 4 days In bed because of mentioned symptoms, 6 days Took Ibuprofen as tolerable Took anti nausea OTC. Called the doctor twice and was told to ? hang in there?. Have never felt worse for so long in my lifetime.
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| 74 | 2021-03-02 | abdominal discomfort |
chest pains; fever over a 100°F; AFib; diabetic; COPD; stomach issues; This is a spontaneous report...
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chest pains; fever over a 100°F; AFib; diabetic; COPD; stomach issues; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received first dose on 25Jan2021 and experienced health issues in Jan2021 as AFib, diabetic, COPD, stomach issues, and reported to "have a lot of issues". The primary doctor thought it's better for her to get the dose than get COVID-19. Patient also reported that about 20 minutes after the first dose on 25Jan2021, patient had chest pains, from one side clear across the other side and took a Nitro, and patient had fever over a 100 degree F for 24 hours. The outcome of the events was unknown. Information on about lot/batch number has been requested.
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| 74 | 2021-03-02 | abdominal pain upper |
my chest started hurting me at 3:50 a.m. this morning; stomach hurts; felt squeezed, I could not bre...
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my chest started hurting me at 3:50 a.m. this morning; stomach hurts; felt squeezed, I could not breath; had the feeling of being squeezed; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and expiry date unknown), via an unspecified route of administration on 15Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 25Jan2021 and experienced AFib, diabetic, COPD, stomach issues, chest pains and fever. About 20 minutes after the first dose, I had chest pains, from one side clear across the other side. She took a nitro, and had fever over a 100°F for 24 hours on Jan2021. She received second dose on 15Feb2021 and experienced they had her get an EKG. Patient felt squeezed, she could not breath on Feb2021. Her oxygen level and blood pressure were both fine on Feb2021. She had the feeling of being squeezed on Feb2021. Her chest started hurting at 3:50 a.m. (16Feb2021) this morning, stomach hurts like doing flip flops inside her. She did not have anything that would aggravate it. The outcome of the events was unknown. The events was reported as non-serious. Information on the batch/lot number has been requested.
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| 74 | 2021-03-02 | diarrhea, vomiting |
fever, chills, HA, vomiting, diarrhea, chest tightness, SOB, nonproductive cough; received 1000 mg a...
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fever, chills, HA, vomiting, diarrhea, chest tightness, SOB, nonproductive cough; received 1000 mg acetaminophen, GI cocktail, liter ND, liter LR, zofran on discharged, mild tacyhpnea with accessory muscle usage (minimal); abdominal tenderness in epigastric area,
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| 74 | 2021-03-02 | diarrhea |
12 hrs after shot I was suddenly sicker than I?d ever been in my life: body shaking chills, fever, ...
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12 hrs after shot I was suddenly sicker than I?d ever been in my life: body shaking chills, fever, headache, body aches. Today I still have fever, body aches, head ache, diarrhea. Haven?t been able to eat.
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| 74 | 2021-03-02 | nausea | Tingly, nausea; pallor |
| 74 | 2021-03-02 | nausea | queasy stomach hot flash rapid pulse metalic taste |
| 74 | 2021-03-02 | nausea |
Nauseated; Fogginess; Light headache; Just not feeling general malaise, Do not feel good; This is a ...
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Nauseated; Fogginess; Light headache; Just not feeling general malaise, Do not feel good; This is a spontaneous report from a contactable nurse (patient herself). A 74-year-old female patient BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/lot number: EN5318, Expiry date: 31May2021), via an unspecified route of administration on left deltoid, first dose on 30Jan2021 13:30 at single dose for COVID-19 vaccination. Medical history included condition on thyroid from an unknown date and unknown if ongoing for thyroid. Concomitant medication included levothyroxine. Patient had given her side effects. She had her vaccine 2 days ago (30Jan2021 13:30). She have had fogginess and have been nauseated, light headache and just not feeling, general malaise, all on an unspecified date in 2021. Due date of Second Vaccine was on 20Feb2021. Treatment in response to the event was trying to get liquids and rest. She got the vaccine at an hospital. Patient had a thyroid test, CBC test and a CMP, they are all normal and had COVID test that was negative on unspecified dates. The action taken in response to the event was unknown.
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| 74 | 2021-03-02 | nausea |
light headed; slight headache; tired; Upper arm became sore and a bit swollen/Upper arm more swollen...
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light headed; slight headache; tired; Upper arm became sore and a bit swollen/Upper arm more swollen and sore.; Upper arm became sore and a bit swollen/Upper arm more swollen and sore.; Did not sleep well overnight (always do) and woke up very tired; sick to stomach; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3248, expiry date not reported), via an unspecified route of administration in the left arm on 30Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included Raynaud's phenomenon. Concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received fluvastatin sodium (LESCOL) and experienced drug hypersensitivity, and nifedipine (ADALAT) and experienced drug hypersensitivity. On 30Jan2021 17:30, in the evening the patient became light headed, had a slight headache and was tired. Her upper arm became sore and a bit swollen. She did not sleep well overnight (always do) and woke up very tired, sick to stomach. Her upper arm was more swollen and sore. No therapeutic measures was taken as a result of the events. Clinical outcome of the events was recovering.
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| 74 | 2021-03-03 | diarrhea, nausea |
Had the runs (diarrhea); Felt numbness in my cheek; Getting nauseous; Not feeling good. Cant do too ...
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Had the runs (diarrhea); Felt numbness in my cheek; Getting nauseous; Not feeling good. Cant do too much of anything, just sit/ sick; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient (also age at vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9269), intramuscular from 30Jan2021 17:00 (5pm) in the left arm at SINGLE DOSE for covid-19 immunization. The patient was vaccinated at a Pharmacy (Pharmacy/drug store). Medical history included ongoing thyroid condition diagnosed at least 10 years ago. Concomitant medication included levothyroxine (LEVOTHYROXINE) at 50mcg tablet once a day by mouth (Taking it for years) for Thyroid/ thyroid condition. For prior vaccinations: The higher dose, senior dose of the flu shot (for immunization), she stopped taking it when the lower dose came out. She gets very sick with the senior dose. She does not know the name and does not have lot number of the senior dose of the flu shot to provide. It was stated to the patient that there may be too much protein in it. The patient is asking if she should get 2nd dose after having negative experience post vaccination of 1st dose. The patient received first dose of vaccine on sat (30Jan2021) evening. It was reported that as soon as she got to her car, "I thought I felt numbness in my cheek. It didn't stay, went right away. My husband thought i was just nervous. It was also stated that she then started "getting nauseous" about 30min after vaccine. The patient has "been sick since I had it.. not sure if its normal? It was also reported that she "had the runs" (diarrhea) for one day, that has now resulted. It was also said that "I'm not feeling good. cant do too much of anything, just sit". The patient asked if this is normal and "when will I feel better"? It was also reported as she had the first dose of the Pfizer covid vaccine late Saturday afternoon at 5pm. She has been feeling nausea and sick since then. She asks if this is normal and how long it will stay. The treatment used was taking Tylenol. It was noted that if she does not do anything and lays down it will go away but if she starts doing too much she will get real nauseous again. It was added that the patient and her husband went to get the vaccine on the same day. It was noted that she felt a little numbness on her face, in her right cheek and then it went away after 20 to 30 seconds. Her husband said she may have been nervous and may have caused that herself. She is a hyper type. The outcome of the event Felt numbness in my cheek recovered on 30Jan2021; for all other events was unknown. There was no additional vaccines administered on same date. No events requires visit to emergency room or physician office. No prior vaccinations (within 4 weeks) reported.
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| 74 | 2021-03-03 | difficulty swallowing |
10:00 patient received second pfizer vaccine 10:40 reported feeling a flushing sensation x 1 approx...
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10:00 patient received second pfizer vaccine 10:40 reported feeling a flushing sensation x 1 approx 10:30, provided bottled water to drink, denies any difficulty breathing, throat swelling, or tongue swelling 11:00 finished bottle of water feeling fine left vaccine clinic accompanied by her husband 11:30 returned to vaccine clinic c/o thick tongue and difficulty swallowing, denies difficulty breathing. Sent to ED. ED note states that patient presented after "near syncopal episode" after developing lightheadedness and flushing after vaccination. Similar episode an hour later (prompting return to medical center). Denied chest pain or shortness of breath on presentation to ED. Described difficulty swallowing and "thick tongue" leading to her presenting back to clinic, but asymptomatic when arrived to ED. Oropharynx free of any swelling. EKG done but only showed sinus bradycardia. Patient observed multiple hours then discharged without any medical intervention taken.
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| 74 | 2021-03-03 | difficulty swallowing |
pain in chest through back; tongue swelled up; difficulty swallowing; This is a spontaneous report f...
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pain in chest through back; tongue swelled up; difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot number EL9764/EL9264), via an unspecified route of administration in the right arm on 01Feb2021 09:45 at a single dose for covid-19 immunization. Medical history included ongoing three stents in her artery, heart issue where they took test to see if she had a heart issue, and everything came back negative, high blood pressure, high cholesterol, overweight, penicillin allergy, IV iodine allergy, allergy to pollens, inhalants, dust and animals. There were no concomitant medications. The patient previously took phenytoin (DILANTIN), bacitracin;neomycin sulfate;polymyxin b sulfate (NEOSPORIN) and cefalexin (KEFLEX); all of which patient experienced allergies/ drug hypersensitivity. On 01Feb2021 09:45, immediately after receiving the vaccine, her tongue swelled up, she had difficulty swallowing, and she has a pain in her chest that went through to her back. The patient was sent and admitted to the ER and got an IV shot injection of diphenhydramine (BENADRYL) that got tongue back down. She didn't need an Epi pen, it wasn't that bad. They took the test to see if she had a heart issue, and everything came back negative. The patient was advised by the head of ER that she shouldn't get the second shot because of the reaction. It could be more severe with the second dose he said. The outcome of the events was recovered on 01Feb2021.
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| 74 | 2021-03-04 | diarrhea, indigestion |
2nd Shot, 2nd day headache, bad muscle ache, third day slight headache redish injection site, fourth...
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2nd Shot, 2nd day headache, bad muscle ache, third day slight headache redish injection site, fourth day bad headache, indigestion and bad diarrhea. Injection site large red, purple, orange (size 2-1/2 " x 1-1/2" very sore. Today, 3/5; reaction site sore but brusing fading. Feel good. 1st Shot was slightly sore arm. Never had fever, cough, chills or vomitting. *** DID NOT CONTACT DOCTOR; WAS NOT EMERGENCY. Just felt like I had flu but thought I should report bad arm reaction.
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| 74 | 2021-03-04 | vomiting, nausea |
Almost threw up last night; joint pain; Few little odd pains; soft pain that make her feel weak and ...
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Almost threw up last night; joint pain; Few little odd pains; soft pain that make her feel weak and then go away; Nauseous; No dizziness, but unsteadiness; Tired; Headaches; began to feel a little bad/ generally didn't feel well/Malaise; Feels like the stomach flu; Weak; Gentle muscle ache; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) via an unspecified route of administration on 28Jan2021 15:30 in left arm at single dose as Covid vaccine, etanercept (ENBREL, 50 mL/mg, Solution for injection in pre-filled pen, lot number: 1119808, expiry date: Apr2023) via an unspecified route of administration from an unspecified date and ongoing at 1 DF weekly to the stomach area for rheumatoid arthritis, methylprednisolone (MEDROL, tablet) oral from an unspecified date and ongoing at 3 mg, daily (1.5 tablets daily for total of 3 mg) for rheumatoid arthritis, methotrexate (tablets) oral from an unspecified date and ongoing at 20 mg, weekly (2.5 mg tablets, 20 mg total) for rheumatoid arthritis. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic or chromosomal abnormalities, endocrine abnormalities (including diabetes and obesity) and took levothyroxine, rheumatoid arthritis. She had had regular blood work for rheumatoid arthritis and that was normal for her, they were relatively normal and her ESR was down. No additional vaccines administered on same date of BNT162B2. No other vaccines given the same day or 4 weeks prior. The patient's concomitant medications included levothyroxine daily for endocrine abnormalities. It was a daily thing for the body and the body couldn't live without it if it did not have it. The patient previously took the Shingrix vaccine and it was terrible for her and put her into a rheumatoid arthritis flare and was taking prednisone and was getting better and the wap she was in a rheumatoid flare. No prior vaccinations received within 4 weeks prior to the first administration date of the suspect vaccine. The patient was taking 3 medicines for rheumatoid arthritis that might or might not affect the RNA in the vaccine. She wondered if etanercept would have an effect on the vaccine since it was shipped on ice overnight. She did not think they would affect anything. Nobody has said anything about the medications and she just wanted to get the vaccine. Her doctor knows nothing about the interactions and none of them seem to know if it is normal to have these symptoms 4 days after getting the vaccine. She felt great the first 2 days after getting the vaccine and then began to feel a little bad. She was having some symptoms maybe 4 days on 01Feb2021 after receiving the Covid vaccine and wanted to know if that was sort of normal. It was unusual for her, but she had nauseous, not dizziness, but unsteadiness, tired, also headaches and generally didn't feel well. She felt like she might have the stomach flu, but had not had that in so many years. She also felt weak. No temperature. Gentle muscle ache. On 01Feb2021 Monday night she had the nausea. On 02Feb2021 Tuesday, she had it again, and had it again today and almost threw up last night. Just the malaise or tiredness had gotten worse. She could not tell the difference between the rheumatoid arthritis, joint pain and muscle pain and this with the vaccine. She was having a few little odd pains, but nothing that she hadn't had before. It was more of a soft pain, they made her feel weak and then they went away. It was more muscle than joint. The events did not require a visit to emergency room or physician office. She was supposed to get a second dose but felt she shouldn't, it might put her back into a rheumatoid flare. She was just getting over it and afraid to go through that with the Covid vaccine also. The action taken in response to the events for etanercept, methylprednisolone and methotrexate was dose not changed. The outcome of events nausea, unsteadiness, tired (tired was reported as worsened), generally does not feel well, feels like the stomach flu, weak, few little odd pains; soft pain, joint pain was not recovered, of other events was unknown.
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| 74 | 2021-03-05 | abdominal discomfort |
Pfizer-BioNTech COVID 19 Vaccine EUA. I had chills, fever of 101.7, headache, stomach upset which s...
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Pfizer-BioNTech COVID 19 Vaccine EUA. I had chills, fever of 101.7, headache, stomach upset which started on 2/10 at 5 pm and lasted for several hours. The chills came and went for about a week, the headache lasted for several days and the stomach upset for a week. I had my second shot, lot number EN6203, on February 22, had the chills and headache about 5 pm on Monday, March 1st that lasted about 5 hours. Then on Friday, March 5th at 11:30 pm, I woke up with the chills, headache and fever of 101.5. The chills last for 4 hours, headache the next day until noon and fever broke about 7 am.
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| 74 | 2021-03-05 | nausea |
Dizziness started day after 1st shot lasting a few hours and occurring every few days. By 3rd week ...
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Dizziness started day after 1st shot lasting a few hours and occurring every few days. By 3rd week dizziness was all day long. The 4th week and after Shot #2 2/9/21 Lot #EN6201 dizziness lasting 24 hours a day. Lightheadedness with occasionally headache. Not serious vertigo or nausea. Had MRI negative, waiting on heart monitor results from cardiologist, had hearing next, ruled out BPPV. Taking meclzine and seems to help somewhat. VNG test maybe next. This is the only significant event in the last 3 months.
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| 74 | 2021-03-05 | nausea | Nausea; BP 183/89 (pulse 87), O2 sat 98%. F/u BP 164/78 (pulse 87). |
| 74 | 2021-03-06 | abdominal discomfort |
EAR ACHE PAIN, JOINT PAIN, UPSET STOMACH, HEAD ACHE, CHILLS, SINUS. NO TREATMENT AND NO OUTCOMES!...
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EAR ACHE PAIN, JOINT PAIN, UPSET STOMACH, HEAD ACHE, CHILLS, SINUS. NO TREATMENT AND NO OUTCOMES!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! WHERE DO I GET THE TREATMENT???????????????????????????????????
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| 74 | 2021-03-07 | abdominal discomfort |
The day after receiving my vaccine I woke up tired, body aches, chills, upset stomach all day. The n...
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The day after receiving my vaccine I woke up tired, body aches, chills, upset stomach all day. The next day I was fine.
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| 74 | 2021-03-07 | abdominal pain upper | Headache, fever, chills, stomach cramps very fatigue, couldn't stay awake |
| 74 | 2021-03-07 | diarrhea, nausea, vomiting |
Patient was admitted to hospital on 3/3/21 for weakness and dehydration. Had presented to ED with na...
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Patient was admitted to hospital on 3/3/21 for weakness and dehydration. Had presented to ED with nausea, vomiting, and diarrhea for 3 days. Tested COVID 19 positive. Found to be hyponatremic. Was treated with IV fluids. Discharged on 3/6/21. Follow labs on 3/8/21.
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| 74 | 2021-03-07 | nausea, diarrhea |
One week after the vaccine (1/13/21) I had a Prolia shot; the first one. About 2 weeks after the fir...
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One week after the vaccine (1/13/21) I had a Prolia shot; the first one. About 2 weeks after the first vaccine I began to be dizzy, nauseous and had diarrhea. Eventually a brain MRI showed an inflamed meninges and numerous test were done, including MRI, CT and lumbar puncture but there has been no answer. It has been suggested I had the Prolia shot too soon after the first vaccine but no one can give me an answer. I am still suffering from dizziness and minor nausea.
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| 74 | 2021-03-07 | nausea, vomiting |
strong chills, low fever, nausea and some vomiting, muscle aches, fatigue for the whole day after va...
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strong chills, low fever, nausea and some vomiting, muscle aches, fatigue for the whole day after vaccine. Fatigue the second day after vaccine. Okay now (3rd say after vaccine)
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| 74 | 2021-03-08 | diarrhea, nausea | Chills, Nausea, Diarrhea, Low Temperature (96) Symptoms lasted for 8 hours |
| 74 | 2021-03-08 | nausea, abdominal pain, diarrhea |
1st 24 hrs-injection site swelling, hot, pain; 2nd 24 hrs-severe abdominal cramps & diarrhea; next 5...
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1st 24 hrs-injection site swelling, hot, pain; 2nd 24 hrs-severe abdominal cramps & diarrhea; next 5 days-nausea, weakness & fatigue - could not eat or smell or even look at food.
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| 74 | 2021-03-08 | nausea |
pt stated a few day after getting the vax she developed headache, muscle aches and pain, nauseated, ...
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pt stated a few day after getting the vax she developed headache, muscle aches and pain, nauseated, swollen lymph nodes, chills, dizziness, weakness, and had anxiety. Pt called ambulance and transported to ER. She was tested for covid w/ negative results. Had blood work w/ abnormal results (mild leukopenia). She was prescribed Benadryl. Her DX ; Dizziness, uncertain, mild medication reaction to the Covid vax. She was released and told to FU w/ PCP. Her FU appt is 3/12/2021.
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| 74 | 2021-03-08 | nausea |
First two days: slight dizziness, nausea, chills, sore arm - only lasting about 1/2 hour each day. ...
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First two days: slight dizziness, nausea, chills, sore arm - only lasting about 1/2 hour each day. Evening of day two: Headache started. and continues each day getting a little worse each day. Took Ibuprofen-helped slightly Day five: Bad headache all day and from previous night. Contacted doctor through MY Chart. He said persistent headaches with Pfizer vaccine were uncommon and suggested a treatment.. I declined as I had used that medication 30+years ago and didn't like it. Day six: Better Day seven: Better Day eight: Still with headache, sinus drainage, chest pain (like I was coming down with a cold) Day nine: No chest pain, drainage and headache, ringing in ears Day ten: More drainage and headache, ringing in ears
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| 74 | 2021-03-09 | nausea |
Shaky, I have a headache off and on. on the 28th I woke up in the night covered in sweat but felt be...
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Shaky, I have a headache off and on. on the 28th I woke up in the night covered in sweat but felt better when I woke up. I haven't felt completely well. On Monday 3/8 I had vertigo and nausea and my arm was sore. I feel disoriented, like I just cant concentrate well. extremely tired, I feel like I could sleep all day.
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| 74 | 2021-03-09 | vomiting, nausea, retching |
11:00 pm - ish: Site of injection began burning which became more intense throughout the night. Cold...
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11:00 pm - ish: Site of injection began burning which became more intense throughout the night. Cold sweats, severe aching and muscle weakness especially in legs, nauseous, severe headache. I tried to drink a little water. Didn't have enough energy and was too cold to get up to get any medication. Slept a little. I was awake early in the morning, but too cold to get out of bed. At 8:30 a.m. I got up and could hardly walk. Dizzy, muscle weakness as if muscles had turned to Jell-O.. Sat down and threw up, mostly dry heaves, which lasted a few minutes. Fitful sleep until 11:00 a.m. when I began to feel better. Drank more water and just rested for a few hours. I ate some applesauce and made a batch of white rice which I ate around 6:00 p.m. Achiness in lower extremities continued until bedtime (10:00 p.m.) when I took a Meloxicam (15 mg) which my GP prescribed for achiness in my neck due to arthritis. I take this drug only when needed and thought it would help the aching in my legs. Maybe it did...maybe it was a coincidence that the achiness was alleviated enough for me to go to sleep. I am almost 100% today. It takes a little longer at my age to fully recover from any illness however slight. I would like to add that I am grateful to be vaccinated.
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| 74 | 2021-03-11 | difficulty swallowing |
weakness, cannot walk, swelling of extremities, could not swallow, gallbladder enlarged and removed,...
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weakness, cannot walk, swelling of extremities, could not swallow, gallbladder enlarged and removed, hospitalized for 14 days. Gullian barre syndrome.
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| 74 | 2021-03-14 | diarrhea, gastrointestinal pain | head ache, moderate lower G.I.cramps, Watery stools x 3, hot flashes and flushing after eating x4 |
| 74 | 2021-03-14 | diarrhea |
Approximately 90 minutes after the injection, patient had an urgently to have a bowel movement. This...
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Approximately 90 minutes after the injection, patient had an urgently to have a bowel movement. This urgency continued until approximately 10 PM that same same day. Anus was very raw and stool very watery. This urgency continued for 7 days after eating food and drinking water. The urgency lessened daily with the drinking of water but with the intake of solid food, the need for an urgent bowl moment continues after 7 dayds.
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| 74 | 2021-03-14 | nausea |
extreme joint pain; severe muscle pain; headache; chills; nausea; This is a spontaneous report from ...
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extreme joint pain; severe muscle pain; headache; chills; nausea; This is a spontaneous report from a non-contactable consumer. A 74-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) intramuscularly on 03Feb2021 (at the age of 74-years-old) as a single dose for COVID-19 immunization. Medical history included Hashimoto's thyroiditis; osteoarthritis; and allergies to medications, food, or other products; all from unknown dates and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included meloxicam from an unknown date for osteoarthritis, which the patient had discontinued 2-3 days prior to immunization. The patient received the vaccine on 03Feb2021, the following day, 04Feb2021, the patient felt like she "got hit by a truck;" she complained of extreme joint pain, severe muscle pain, headache, chills and nausea. The events were reported as non-serious and did not require hospitalization. It was unknown if treatment was provided for the events. The patient reported she gradually improved over the next 3-4 days and resolved. The clinical outcomes of extreme joint pain, severe muscle pain, headache, chills, and nausea were recovered in Feb2021. It was also reported the patient had not been tested for COVID-19 since vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 74 | 2021-03-14 | vomiting | Dizziness, vertigo, vomiting |
| 74 | 2021-03-15 | indigestion | Chills, aches in joints, head, skin. Slight indigestion. |
| 74 | 2021-03-16 | diarrhea | Severe diarrhea for nine days since injection |
| 74 | 2021-03-16 | nausea, diarrhea | Severe severe headache. Nausea and diarrhea. Plus sore arm. |
| 74 | 2021-03-16 | nausea |
Approximately 10 minutes after patient received her Pfizer vaccine she stated that "she need to move...
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Approximately 10 minutes after patient received her Pfizer vaccine she stated that "she need to move her bowels." Then she started to become nauseous and turned pale. EMS assessed her. Patient's heart rate dropped. Patient was lying down. Patient was then taken to the hospital in stable condition.
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| 74 | 2021-03-17 | nausea |
Became ill two days after vaccination, slight fever , nausea, headache, forgetful , unsteady on feet...
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Became ill two days after vaccination, slight fever , nausea, headache, forgetful , unsteady on feet , sleepy
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| 74 | 2021-03-18 | abdominal discomfort | Tongue Swelling, Dizziness, Upset Stomach, Anaphylaxis |
| 74 | 2021-03-18 | decreased appetite, vomiting, nausea |
Sore injection site; joint aches; Chills; headache; nausea; vomiting; muscle pain; listless; fever; ...
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Sore injection site; joint aches; Chills; headache; nausea; vomiting; muscle pain; listless; fever; no appetite; Not feeling well; still tired; sleeping a lot; Very fearful of taking the second shot; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 08Feb2021 (Lot Number: EM0910) as single dose for covid-19 immunization. Medical history included mild chronic obstructive pulmonary disease, asthma, bronchitis, sinus infection and sulfa allergy from unknown dates. The patient previously took and experienced allergies to acetaminophen, montelukast sodium, hydroxyzine, budesonide-formoterol fumarate and pseudoephedrine hcl. On 09Feb2021, at 01:00, the patient experienced sore injection site with outcome of unknown; joint aches with outcome of unknown; chills with outcome of unknown; headache with outcome of unknown; nausea with outcome of unknown; vomiting with outcome of unknown; muscle pain with outcome of unknown; listless with outcome of not recovered; fever with outcome of unknown; no appetite with outcome of unknown; not feeling well with outcome of unknown; still tired with outcome of not recovered; sleeping a lot with outcome of not recovered; very fearful of taking the second shot with outcome of not recovered. No treatments were given for the events. Details were as follows: the adverse events included sore injection site, joint aches, chills, headache, nausea, vomiting, muscle pain, listless, fever, no appetite, not feeling well, all in that order. Worst side effects were gone by the third day; she was still tired, sleeping a lot and was listless. The patient was also very fearful of taking the second shot. The events resulted in doctor or other healthcare professional office or clinic visit on an unspecified date.
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| 74 | 2021-03-18 | difficulty swallowing |
Pt received 2nd dose of Pfizer Covid vaccine today approx 9:14AM; pfizer lot number EL9266. Patient ...
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Pt received 2nd dose of Pfizer Covid vaccine today approx 9:14AM; pfizer lot number EL9266. Patient has hx of throat swelling from PO Sulfa. Pt alerted nurse at 9:35AM that she was experiencing a generalized prickle sensation. P60 O2RA 97%. At 09:54AM pt experiencing widespread prickle sensation, tightening in throat, difficulty swallowing, disorientation, and light headedness. Epi 0.3mg auto injector(Lot 0FM534) administered left leg 9:54AM per RN; BP 198/72 P75, O2RA 98%. EMS called 9:55AM, arrived at 9:59AM and assumed care of patient. Patient transported to Hospital.
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| 74 | 2021-03-18 | nausea |
Soreness in arms/shooting pains in her right arm that are shooting; Breasts are sensitive/Her breast...
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Soreness in arms/shooting pains in her right arm that are shooting; Breasts are sensitive/Her breasts are very sensitive and sore; Breasts are sensitive/Her breasts are very sensitive and sore; Swelling in her calves, her left and right arms; Swelling in her calves, her left and right arms/her hand was swollen, and her whole arm was like a log, it has been very uncomfortable; Her arm is very, very sore at the site of injection/Her right arm where vaccine was given her elbow is still swollen and sore below injection, and swelling where arm is connected to elbow.; Her joints in her elbows, wrists, and ankles are hurting/lot of joint pain; Nauseous; lymph nodes were affected and swelling; Tired; Swelling everywhere; Her right arm where vaccine was given her elbow is still swollen and sore below injection, and swelling where arm is connected to elbow.; uncomfortable; This is a spontaneous report from Social Media by a contactable consumer (patient). A female patient of 74-year-old received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via unspecified route of administration in right arm on 05Feb2021 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. The patient medical history included chronic kidney disease from an unknown date in 2012. The concomitant medication was not reported. The patient stated that have not had any other recent vaccinations or started any new medications. The patient reported that on an unknown date Feb2021, soreness in arms, she has had swelling in her calves, her left and right arms. She said her arm is very, very sore at the site of injection, her breasts are very sensitive and sore, nauseous and later went away, had a lot of joint pain and swelling everywhere, her lymph nodes were affected and swelling, her right arm where vaccine was given her elbow was still swollen and sore below injection and also specified that swelling where arm is connected to elbow. It was also reported that hand was swollen, and her whole arm was like a log, it has been very uncomfortable on an unknown date in Feb2021. The patient has been tired on an unknown date in Feb2021 and patient worried about recovery of events. The patient stated that lymph nodes took 2-3 days, which started Sunday (as reported). It was reported that patient was still in sore, the breasts are super sensitive, which was weird. The patient also had strange shooting pains in her right arm that are shooting through it. The patient left arm was sore, but not as sore as her right. She said her knuckles were cracking when her hands move, and her right wrist was very sore but that was not so bad now. The patient stated that she thought these events were due to her good immune system. The joints were still sore, her elbows, all of the upper part of her body were also sore. The patient also reported that she was told older people don't have much reactions, but she certainly had. The patient had not seen doctor for the events. The patient took acetaminophen (LOT M045G, EXP Dec2023) as a treatment medication for the events. The outcome of the events nauseous was recovered on an unknown date in Feb2021, for the events swelling everywhere, uncomfortable, tired, lymph nodes were affected and swelling, breasts are sensitive/her breasts are very sensitive and sore was unknown while for rest of the events was not recovered
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| 74 | 2021-03-21 | decreased appetite |
She received her 2nd vaccine and started feeling very chilled and tired around 6:30 that evening, st...
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She received her 2nd vaccine and started feeling very chilled and tired around 6:30 that evening, started shaking and feeling like restlessness. She went to bed and covered up under lots of covers, and just froze. She put on extra clothes, layers of blankets and her legs felt swollen, painful. She kept having to urinate a lot, could not sleep, was awake all night, her arm started hurting as well, could not lay on that side, and then started getting cold/hot flashes. She felt as though her heart was racing, and her brain as well trying to figure out what was happening. Her husband took her temperature in the morning and it was 101.9, which her normal is 97.9. At that point she was exhausted from being up all night, and was frightening and couldn't stop trembling all night long into Saturday. When day broke on Saturday shew as not able to get out of bed for the entire day. She could not eat, had no appetite and drank water day. On Sunday she felt a little better, ate breakfast and the rest of the day went okay other than being exhausted. This morning, 3/22/21, she still feels lofty, is able to function and feels a little removed/foggy feeling. She is still not feeling completely well, but is on her way. Not steady on her feet yet. She took some Bayer aspirin for the symptoms.
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| 74 | 2021-03-22 | vomiting |
excruciating pain all over the body and headache which started after covid vaccine on 3/8 Pfizer. Sy...
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excruciating pain all over the body and headache which started after covid vaccine on 3/8 Pfizer. Symptoms started 3/12. Stopped the crestor and only the leg cramps stopped. Tylenol and baclofen did not help. Went to ER for pain and was given IV dilaudid and toradol which helped at the time. She was rx norco. She tried 2 tabs at a time and threw up. She is just takin g1 tab q4 hrs now which helps with the body aches but not the headache.
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| 74 | 2021-03-23 | nausea, vomiting |
Patient is a 74 year old y.o. female with history of atrial fibrillation, hypothyroidism who present...
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Patient is a 74 year old y.o. female with history of atrial fibrillation, hypothyroidism who presents with acute onset early this a.m. nausea vomiting and change in mental status. History was obtained from the husband as patient is minimally responsive to verbal stimuli at this time. He states she was in her usual state of health until when she awoke this morning. Yesterday in usual state of health that she did have her 2nd COVID vaccine with the Pfizer variant. He states that day she was in her usual state of health with some mild arm pain on the left where she received the vaccine. This morning she awoke with a headache, fever, chills however was ambulating and conversing appropriately. She had no appreciable focal deficits at that time per the husband. She ate breakfast however she subsequently began vomiting. She progressed to a change in mental status with minimal responsiveness. She would say 1 or 2 words and that was it. They then presented emergency department. Diagnosed with severe sepsis, acute encephalopathy, acute meningitis, liver shock, autoimmune hepatitis, ascending cholangitis, acute pancreatitis.
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| 74 | 2021-03-23 | vomiting |
patient received COVID-19 vaccine on 3/8 with symptoms starting on 3/12. patient complains of excruc...
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patient received COVID-19 vaccine on 3/8 with symptoms starting on 3/12. patient complains of excruciating pain all over the body and headache. Stopped the crestor and only the leg cramps stopped. Tylenol and baclofen did not help. Went to ER for pain and was given IV dilaudid and toradol which helped at the time. She was rx norco. She tried 2 tabs at a time and threw up. She is just takin g1 tab q4 hrs now which helps with the body aches but not the headache. She could hardly walk and get out of bed due to the pain. Labs unremarkable. Patient also has intolerances to atorvastatin and rosuvastatin with history of muscle cramps.
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| 74 | 2021-03-24 | nausea |
First day, excruciating pain over my entire body, could hardly get out of bed, chills, hot flashes, ...
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First day, excruciating pain over my entire body, could hardly get out of bed, chills, hot flashes, nausea, extreme tiredness that sleep did not help. Also, hot flashes during night. took Tylenol. Second day, pains were mostly gone, but nausea and a sore arm where the injection was given, and dizziness, and tiredness. But if I would lie down, I couldn't sleep. Later that day my injection site was swollen, redness (about size of an orange) sore to the touch and itched, and was hard. The third day my injection sites pain went further to my left breast, up to my shoulder. It had spread and was now a light pink. A small amount of dizziness.
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| 74 | 2021-03-25 | nausea, vomiting |
Nausea, vomiting, dry mouth, headache, slightly elevated temperature. Unable able to sit up or get ...
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Nausea, vomiting, dry mouth, headache, slightly elevated temperature. Unable able to sit up or get out of bed except to vomit. Unable to eat or drink, even water. I tried sitting up around 11 p.m. but after less than 5 minutes I felt nauseous. Slept fitfully through the night but felt more normal when I got up at 7 a.m. on 03/20 (next e morning)
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| 74 | 2021-03-30 | abdominal discomfort, constipation |
severe constipation; nervous; sever abdominal discomfort; This is a spontaneous report from a contac...
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severe constipation; nervous; sever abdominal discomfort; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via unspecified route of administration on 30Jan2021 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. The patient medical history included blood pressure and cholesterol. The patient concomitant medication included amlodipine besilate (NORVASC) and simvastatin. The patient previously took historical vaccine, first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) for COVID-19 immunisation. On an unknown date in Jan2021 the patient experienced severe abdominal discomfort and developed severe constipation on 31Jan2021. The patient felt nervous on an unknown date in Jan2021. The patient wanted to know if the events caused were due to vaccine. The patient took Miralax and a suppository (not specified) as treatment to severe abdominal discomfort and severe constipation. The seriousness of the events was reported as non-serious. The outcome of the event severe constipation was not recovered while for other events was unknown.
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| 74 | 2021-03-30 | difficulty swallowing |
Chills; Irritation in throat; Swelling of tongue; Unable to swallow solids; This is a spontaneous re...
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Chills; Irritation in throat; Swelling of tongue; Unable to swallow solids; This is a spontaneous report from a contactable nurse (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), dose 2 via an unspecified route of administration, administered in the right arm on 25Feb2021 for covid-19 immunization. The patient's medical history was not reported; She takes other unspecified medications, though declined to provide details. The patient previously took BNT162B2 (Lot EM9809) on 04Feb2021 as first single dose for covid-19 immunization and hydrochlorothiazide and experienced anaphylactic reaction on an unspecified date (reported as years ago). The patient experienced the following medically significant events: irritation in throat on 27Feb2021 with outcome of recovered; swelling of tongue on 27Feb2021 with outcome of not recovered; unable to swallow solids on 27Feb2021 with outcome of not recovered; chills on an unspecified date with outcome of unknown. Details were as follows: the reporting nurse received both doses of the Covid-19 vaccine. She received the first dose on 04Feb2021. She received the second dose on 25Feb2021. 48 hours after the second dose she developed a really sore throat way down in the back of her throat. Her tongue also started swelling. She took diphenhydramine (ASSURED) 50mg. Her tongue was swollen the next day and she was unable to swallow solids. She went to a Covid clinic and was prescribed a diphenhydramine mouthwash. She was still unable to swallow. She has been taking diphenhydramine and Ibuprofen. It waxes and wanes. She had to take diphenhydramine to go to sleep. She thinks it is a reaction to the vaccine. She read about the ingredients and is not allergic to anything in the vaccine. She clarified that she did not have a sore throat. Her throat was irritated. It felt like pop rocks in the back of her throat. She saw a provider on 01Mar2021. She thinks her histamine level is too high. She also had chills last night, date unspecified. She had them once since 27Feb2021 and again last night. She was unable to confirm if they are ongoing or resolved. She had to turn up her electric blanket to 8. She was not shaking but just had chills. Years ago she had an anaphylactic reaction to hydrochlorothiazide. This felt similar to that. She was walking around fine and then started having swelling. She did not have difficulty breathing. She hoped it was not anaphylaxis. The diphenhydramine mouthwash was a compound of lidocaine, diphenhydramine and Maalox. The ratio was 1:1:1. The diphenhydramine 50 mg was a liquid children's allergy relief medication. Therapeutic measures were taken as a result of the events as aforementioned. Relatedness of drug to reaction for irritation in throat, swelling of tongue, unable to swallow solids and chills per primary source reporter of assessment was reported as related. The outcome of irritation in throat was recovered on 28Feb2021; the outcome of swelling of tongue and unable to swallow solids was not recovered; the outcome of chills was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of irritation in throat, swelling of tongue, unable to swallow solids due to temporal relationship and the known product safety profile. The clinical presentation is suggestive of a severe allergic reaction, involving the tongue and throat. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 74 | 2021-03-30 | stomatitis |
mouth sores; slightly swollen upper lip; swelling/pain injection site; swelling/pain injection site;...
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mouth sores; slightly swollen upper lip; swelling/pain injection site; swelling/pain injection site; fatigue; headache; This is a spontaneous report from a contactable consumer or other non hcp. A 74-years-old female patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EKU176, Brand: Pfizer, Expiration date: Unknown) via an unspecified route of administration in right arm on 18Jan2021 14:00 as single dose for covid-19 immunisation. Medical history included bronchiectasis, degen scoliosis, fibromyalgia, peptic esophogitus and swollen lymph nodes for 24 hrs, fatigue and headache for 4-5 days for first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EL1284, Brand: Pfizer, Expiration date: Unknown) via an unspecified route of administration in right arm on 02Jan2021 11:00 as single dose for covid-19 immunisation. There was special history of allergies reported. Concomitant medication pantoprazole sodium diclofenac sodium 40 mg, Misoprostol (50-200) (ARTHROTEC) and lisinopril for unspecified indication. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On an unspecified date in Jan2021, the patient experienced mouth sores, slightly swollen upper lip, swelling/pain injection site, fatigue and headache. The patient hasn't been tested PCR for COVID-19 post the vaccination. Therapeutic measures were not taken as a result of events. The outcome of the events were not recovered.
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| 74 | 2021-03-30 | vomiting, abdominal discomfort |
Stomach upset; Headache; It was like black darkness was coming over my head; Afraid; I was going to ...
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Stomach upset; Headache; It was like black darkness was coming over my head; Afraid; I was going to faint; I got really weak; Felt like I was going to threw up; Light-headed; I did feel like I was going to lose consciousness; This is a spontaneous report from a contactable nurse (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) (Batch/Lot Number: EL9261 and Expiry Date was Unknown) via an unspecified route of administration on 28Jan2021 12:45 at single dose for covid-19 immunization. Medical history included diabetes and asthma. Concomitant medications included empagliflozin (JARDIANCE) and lisinopril. Consumer (Retired Nurse) stated, "I had my COVID Vaccine first dose yesterday 28Jan2021 at 12:45 in the afternoon and I was standing in my kitchen cooking and all of sudden I got really weak and light headed and it was like black darkness was coming over my head. I was afraid, I was going to faint. My stomach was upset. I made up to the bathroom, sat on the toilet, had a bowel movement and felt like I was going to threw up, never did threw up. I got real tired from headache and I just sat there until I thought it was safe to stand, which I did. So, I was reading in my little brochure and it said what to call this number to report any side effect so I was not dizzy but I did feel like I was going to lose consciousness." The patient assessed the events as non-serious with outcome of unknown. Reported causality for COVID Vaccine to events for stomach upset, headache was related.
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| 74 | 2021-03-31 | nausea |
a little tired; passed out; weakness; disorientation when walking; headache; nausea; hand on the si...
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a little tired; passed out; weakness; disorientation when walking; headache; nausea; hand on the side that she got the vaccine was cold; Second dose: pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received BNT162B2, dose 2, via intramuscular, administered in right arm on 16Mar2021 10:00 AM (Lot Number: EN6204; Expiration Date: Jun2021) as single dose for COVID-19 immunisation. Vaccination facility type was hospital. Medical history included eczema from 2017, she had eczema all over her back and arms and had mild allergies to mold and juniper. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 at the age of 74-year-old on 23Feb2021 at 10:00AM (lot number: EN6198, Expiry: Jun2021) intramuscular injection in left arm and experienced pain at injection site and couldn't sleep. The patient also took Prolia shots for arthritis. The patient experienced headache, nausea, pain at injection site and hand on the side that she got the vaccine was cold on 16Mar2021, passed out, weakness and disorientation when walking on 17Mar2021, a little tired on 18Mar2021. The clinical course included: The patient was calling about the second vaccine that she got on 16Mar2021 (Tuesday). She was calling about the after effects. They were quite huge. She had a headache, nausea, weakness, and disorientation when walking. Stated she obviously had pain at the site of injection. Stated some of it was her own fault, and at first she felt fine. On the same day that she got her second dose of the covid vaccine, she had a glass of wine and was not too hungry. She ate a little that evening. The next morning she passed out. Clarified that she had two glasses of wine, not one. Caller's daughter was a doctor. Caller referd to her daughter as doctor daughter. Stated that she told her daughter about what happened. Her daughter told her it was because she was dehydrated. Her daughter told her that it was called vagus something or another. Her daughter was not there with the caller. Her daughter called it vagus something, she does not remember. Her daughter told her that it had to do with inflammation and her immune system. Caller stated she also has arthritis. Her daughter told her that she was stupid for drinking wine after receiving the second dose of the covid vaccine and not eating a full meal. Whenever she passed out and fell, she did not hurt herself but it was a wake up call. She realized she was vulnerable. She was calling because she did not know why no one told her to drink a lot of water after receiving the vaccine. She got a Prolia shot in July and the nurses told her to drink a lot of water. She was asking why the nurses who gave her the covid vaccine are not saying that to people. Her daughter told her to call the doctors office about this, and she told her daughter that it was over with now, she's 95%, she was a little tired on 18Mar2021. She was unconscious for 15 seconds per her husband. Her husband was shouting her name, and she did not hear anything. She wanted to call and report that the nurses should tell people to drink water. One more thing, her daughter told her that the covid vaccine was slowly released. About 10 hours after receiving the second dose of the covid vaccine her hand on the side that she got the vaccine was cold. She got the vaccine about 10AM, and about 10PM at night is whenever her hand got cold. She had pain at the injection site where she had the first dose of the vaccine too. She had more pain at injection site after the second dose of the vaccine. It was not awful, but only if she pressed on it. Clarified that she gets Prolia shots twice a year for her arthritis. Luckily whenever she started to get dizzy, she braced her self, whenever she fell, she did not fall from an upright position. She was crouched over, and fell against trays that fell with her. Her doctor daughter told her that inflammation was because of her immune system. One other thing was that she has been stung in the past and had extreme reactions from yellow jackets in the 90's. She thought her immune system was sensitive. One other things related to her autoimmune from 3 years ago. She moved to a city in 2012. Everyone told her after 5 years she would develop allergies. In 2017, she had eczema all over her back and arms. It was not just like a topical thing where she scratched and itched, it was under her skin. She went to a dermatologist and he took a biopsy, but the results just said eczema. She went to an allergist, he finally found a space on her underarms where he could do a test. The test showed that she had mild allergies to mold and juniper. Juniper is a tree that they have there, she has one in her back yard. Her allergy was very mild. She tried everything, and in 4 months it went away. Now she just latherers her skin with coconut oil. Her diagnosis that this autoimmune issue was related her immune response from the yellow jacket reaction is a self diagnosis. A doctor had never told her this, this was coming from her own self. Clarified that she is calling about the second dose of the pfizer covid 19 vaccine. Headache: It was not a bad headache, it was more like pressure all across the top. Whenever she went to sleep, the headache started. She got the second dose of the covid vaccine on 16Mar2021. She had a little bit of a headache this morning. A cup of coffee with milk made it better. Nausea: It started whenever she did not want to eat dinner. She could tell her stomach was not right. The nausea and headache started together about 12 hours after her vaccine at 10:00 PM. Weakness: She noticed weakness on the next day whenever she got up to use the bathroom. Clarified as the early morning of 17Mar2021. Her weakness was about 90 percent resolved. Disorientation when walking: Clarified that her disorientation was in reference to walking only right before she fell. She was not mentally disoriented. Mentally she knew that she was not doing well. Second dose: pain at injection site: The pain only lasted for about 2-3 hours. It was now absolutely minimal. She would have to press on it to feel anything. Her hand on the side that she got the vaccine was cold: She got the second dose of the covid vaccine around 10:00 AM, and noticed her hand was cold about 5:00 PM., about 7-8 hours later. Whenever she went to bed, she was cold. She thought that it resolved by the next morning. The morning after receiving the second dose of the covid vaccine, she passed out: She passed out about 8:15 AM. The outcome of the events headache, nausea, weakness, pain at injection site was recovering. The outcome of the events disorientation when walking and her hand on the side that she got the vaccine was cold was recovered on 17Mar2021. The outcome of the other events was unknown.
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| 74 | 2021-04-06 | nausea, vomiting |
her blood pressure was very low the next morning; she felt really weak; nausea; she lost a lot of fl...
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her blood pressure was very low the next morning; she felt really weak; nausea; she lost a lot of fluids/I was so dehydrated; hadn't eaten anything; stated she started salivating and then threw up; stated she threw up once; she had a severe headache; she was shivering all evening and she couldn't get warm; she had body aches; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3249, NDC number: Unknown, Expiration Date: May2021, Manufacturer: Unspecified) via an unspecified route of administration at right arm on 15Jan2021 at single dose for COVID-19 immunisation. Medical history of patient included knee pain and anxiety. Patient's concomitant medications included tramadol, paracetamol both 500 mg for knee pain and hydroxyzine hydrochloride (25mg tablet up to three times a day as needed by mouth, she does not take every day) for anxiety. On 15Jan2021 after vaccination patient experienced salivating and then threw up, stated she threw up once, severe headache, shivering all evening and she couldn't get warm, body aches, nausea, lost a lot of fluids/I was so dehydrated, hadn't eaten anything and her blood pressure was very low the next morning, she felt really weak on 16Jan2021. She required urgent care trip for IV fluids, "She was so dehydrated" and was "miserable" with her symptoms. She said she lost a lot of fluids and hadn't eaten anything. Patient wants to get the second COVID-19 vaccine dose because she is scheduled to have a knee replacement on 26Feb2021. She said she also had to deal with the pain in her knee, clarifying that is why she is getting a knee replacement. IV fluids (clarified as Saline), tylenol given as treatment. She reported when she got home she drank Pedialyte to try to rehydrate herself. She reported she went to urgent care on Saturday (16Jan2021), and by Monday 18Jan2021, she was feeling better, but she didn't golf on Tuesday, 19Jan2021. patient underwent lab tests and procedures which included blood pressure measurement which very low, influenza virus test and sars-cov-2 test was negative on 16Jan2021, blood test was fine. Patient said yes for investigation assessment. The outcome of event was recovered on 15Jan2021 for Increased salivation and Vomited and for all other event outcome was recovered on Jan2021.
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| 74 | 2021-04-09 | vomiting, nausea |
February 17, 2021: Patient received 1st dose of PfizerBioNTech vaccine. Reported mild cough, nause...
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February 17, 2021: Patient received 1st dose of PfizerBioNTech vaccine. Reported mild cough, nausea and bone pain lasting one week. However, she felt it wasn't severe enough to contact me as her asthma specialist. No cough per patient for the week prior to the second dose of PfizerBioNTech. March 10, 2021: Patient received 2nd dose of PfizerBioNTech vaccine at 1:10pm. Said she had mild chest tightness during the waiting period and used her Ventolin but she attributed it to the characteristics of the waiting room area. Between 5:00pm and 6:00pm (~4 hours later), she became light-headed, vomited and began to cough frequently. She contacted her primary care physician who told her to use Mucinex and contact me if needed. March 12, 2021: Patient contacted my office in the early afternoon. Unable to stop coughing while on telephone. Came to office approximately 90 minutes later. Physical Exam; Peak Flow 210 (personal best 310-320), oxygen saturation 93-95% (typically 97-98%), temp-98.2 F. Intractable cough with scattered bilateral expiratory wheezes on auscultation. Heart rate 132 and regular. Patient treated with Levalbuterol 1.25 mg nebulization with subsequent modest improvement in frequency of cough, pulse 102, oxygen saturation 96-97%. She declined going to emergency department of hospital because she did not want to get infected with COVID-19 from a patient in the waiting room. She declined Prednisone when told that the corticosteroid might reduce the efficacy of the 2nd dose of the vaccine. Placed on Budesonide 1 mg bid and Levalbuterol 1.25 mg q4-6h prn. March 16th: Patient reported her cough was 70% improved and wanted to stop Budesonide. Patient was told to continue Budesonide daily at 1 mg q day. April 5th: Patient contacted my office because of continued coughing and wheezing. Had been hospitalized March 25-27 for the cough.
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| 74 | 2021-04-12 | abdominal pain | Death Sepsis abdominal pain |
| 74 | 2021-04-12 | nausea, diarrhea |
Two days after receiving vaccine patient and family reports patient developed nausea and headache. s...
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Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report.
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| 74 | 2021-04-13 | abdominal pain |
Patient presented to the hospital for low hemoglobin, hematuria, abdominal pain, and cough. The pati...
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Patient presented to the hospital for low hemoglobin, hematuria, abdominal pain, and cough. The patient tested positive for COVID-19 upon admission to the hospital on 3/24/2021. CXR showed mild pulmonary vascular congestion. The patient was on 2L/min supplemental oxygen throughout admission.
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| 74 | 2021-04-23 | diarrhea |
very tired; sleeping alot; dizzy spells; diarrhea; This is a spontaneous report from a contactable c...
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very tired; sleeping alot; dizzy spells; diarrhea; This is a spontaneous report from a contactable consumer. A 74-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318), via an unspecified route of administration on 04Feb2021 13:30 (at the age of 74-years) as SINGLE DOSE in Arm Left for covid-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included Lung cancer (lobectomy), copd, emphysema. The patient previously took Pcn (penicillin), codeine, morphine, Indocin and had drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. Prior to the vaccination the patient was not diagnosed with COVID-19. On 05Feb2021, the patient experienced very tired, sleeping alot, dizzy spells and diarrhea. The patient did not receive any treatment. Since the vaccination the patient had not been tested for COVID-19. The outcome of events was not recovered.
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| 74 | 2021-04-24 | diarrhea, abdominal pain upper |
I fainted and hit my head.; I fainted and hit my head.; passing out; stomach cramps; diarrhea; chill...
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I fainted and hit my head.; I fainted and hit my head.; passing out; stomach cramps; diarrhea; chills; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 20Mar2021 12:45 (Batch/Lot Number: EN6208) as SINGLE DOSE for covid-19 immunisation. Medical history included Thyroidectomy. Concomitant medications included pravastatin sodium (PRAVASTATIN SODIUM); levothyroxine sodium (SYNTHROID); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]). The patient received first dose of BNT162B2 on 27Feb2021 at 74-years-old for COVID-19 immunization: lot number=EN6203, lot unknown=False, administration date=27Feb2021, vaccine location=Left arm, dose number=1. On 22Mar2021 16:00, the patient fainted and hit her head. On 21Mar2021, the patient had stomach cramps, diarrhea and chills. I was wondering if passing out was an uncommon side effect. The outcome of the events was recovered. The patient received treatment for the events.
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| 74 | 2021-04-24 | nausea |
Headache like my head was going to explode/severe headache like migraine/Pain level 10/10; headache ...
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Headache like my head was going to explode/severe headache like migraine/Pain level 10/10; headache like migraine/chronic migraine; symptoms of a stroke; weakness on my right side from tongue to nose; weakness on my right side from tongue to nose; extreme nausea; general malaise; My shot arm feel like felt like I had been hit for several days; This is a spontaneous report from a contactable consumer (the patient). A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN5318) via an unspecified route of administration on 09Feb2021 at age of 74-year-old at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302) on 19Jan2021 at age of 74-year-old for COVID-19 Immunization, the patient had no soreness or reaction until 10days later on 29Jan2021 when she had a low fever ~0.5-1 degree with chills and aches like a fever for 3 days, the patient experienced aches and pain; hurting all over on 29Jan2021, the patient took no medications, there were no further reaction. The second shot given on 09Feb2021, the patient's shot arm felt like she had been hit for several days beginning 10Feb2021. On 11Feb2021, the patient got a severe headache like migraine. Pain level 10/10. She had chronic migraine with all symptoms of a stroke (extreme nausea and weakness on her right side from tongue to nose, extreme headache about left side of the head). The headache on 11Feb2021 was overlap headache. On both sides of head and nausea. No other migraine symptoms. It lasted for 3 days. The patient was hospitalized due to the event(s) headache like my head was going to explode/severe headache like migraine/ chronic migraine. The patient took only butalbital, caffeine, paracetamol (FIORICET, 50, 325-40) from 11Feb2021 to 12Feb2021 at 40mg caff for several headache like migraine; promethazine (PHENERGAN) from 11Feb2021 to 12Feb2021 at 25mg for several nausea. The patient had several events general malaise where she didnot feel like doing her thing until today 30Mar2021. She had taken no medications or seen a doctor about it. The outcome of "headache like my head was going to explode/severe headache like migraine/pain level 10/10", "headache like migraine/chronic migraine" was recovered in 2021. The outcome of other events was unknown.; Sender's Comments: Linked Report(s) : PFIZER INC-2021145090 same patient, same drug, different event, different dose separated in times
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| 74 | 2021-04-25 | diarrhea, nausea |
She had diareah and nausea for a few days with 1st shot but it got better. She complained about "fee...
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She had diareah and nausea for a few days with 1st shot but it got better. She complained about "feeling off" after the 2nd shot. Went to bed to try to sleep it off and she never got up again. We think she died Wednesday night or Thursday morning by how she stopped responding to texts. She was found deceased on Friday. They won't do an autopsy here. funeral home has her for now.
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| 74 | 2021-04-26 | vomiting |
body aches; diuresis; shortness of breath with pO2 = 84; chills (used every blanket that I could fin...
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body aches; diuresis; shortness of breath with pO2 = 84; chills (used every blanket that I could find; tremendous thirst; vomiting; This is a spontaneous report from a contactable consumer (patient). A 74-year-old non pregnant female patient second dose received bnt162b2 (BNT162B2, solution for injection, single dose; age at time of vaccination 74-year), via an unspecified route of administration in left arm on 12Feb2021 13:15 as single dose for covid-19. Medical history included Multiple connective tissue disorder; COVID-19. The patient concomitant medication included prednisone (unknown formulation) from 29Jan2021 at 10 mg, daily. The patient previously received first single dose of bnt162b2 on 22Jan2021 single dose for Covid-19 immunization (age at time of vaccination 74-year). Also had Sulfa drugs allergy. the patient receive other vaccines within 4 weeks prior to the COVID vaccine; other medications the patient received within 2 weeks of vaccination was Prednisone 10mg/day. On 12Feb2021 23:00, chills (used every blanket that I could find), tremendous thirst, vomiting. In the morning and next day (13Feb2021) body aches and diuresis. Next night (13FEB2021) shortness of breath with p02 84. By morning of (14Feb2021) shortness of breath was gone and p02 back to 96. Vomiting and aches continued for part of the day. Patient not received treatment for the adverse event. The reported seriousness for all events was non serious. Prior to vaccination, the patient diagnosed with COVID-19; Since the vaccination, the patient not tested for COVID-19. The outcome of the events chills, tremendous thirst, vomiting, body aches and diuresis was reported as recovering and the patient recovered from the event shortness of breath on 14Feb2021. Information on the lot/batch number has been requested.
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| 74 | 2021-05-09 | abdominal pain, vomiting |
This 74 year old female received the Covid shot on 3/12/21 and went to the ED on 4/11/21 with t...
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This 74 year old female received the Covid shot on 3/12/21 and went to the ED on 4/11/21 with the diagnoses listed below and died on 5/3/21. ABDOMINAL PAIN VOMITING
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| 74 | 2021-05-09 | abdominal pain |
Severe Abdominal pain starting 3/24/21. Went to ER 4/13/21 due to abdominal pain.. Admitted to hos...
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Severe Abdominal pain starting 3/24/21. Went to ER 4/13/21 due to abdominal pain.. Admitted to hospital due to very low platelet count of 4,000, Also very low WBC and ANC. While in hospital, received three infusions over three days of platelets. Platelets came up and then dropped. Day 4 and 5 started on high doses of steroids with Gamma globulin infusions both days. Discharged on 4/19/2021. Continued follow-up and care through Cancer care specialists with Dr. Platelets stable but continue in low range. WBC/ANC still critically low. Considered very high risk for infection Receiving Retuximab infusions. Once a week for 4 weeks. Have completed one.
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| 74 | 2021-05-13 | vomiting |
3 days sick; Threw up; Headache; 101.8 Fever; Ached all over; Very tired; This is a spontaneous repo...
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3 days sick; Threw up; Headache; 101.8 Fever; Ached all over; Very tired; This is a spontaneous report from a contactable consumer (reporting herself). This 74-Year-old Female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6198), via an unspecified route of administration in arm on 01Mar2021 at 14:50 as a single dose for COVID-19 immunization. Previously, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Ph9264), via an unspecified route of administration in arm on 09Feb2021 at 10:00 as a single dose for COVID-19 immunization. The patient's medical history reported as MONO-EBU started one year ago and its ongoing. The concomitant medication were not reported. On 01Mar2021, the patient experienced three days sickness, very tired, threw up, headache, 101.8 fever, ache all over in bed 3-day. The outcome of the event three days sickness was recovering, very tired was recovered and other events was unknown.
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| 75 | 2021-01-01 | nausea |
Fever, chills, nausea beginning about 6 hours after the vaccination and continuing for about 36 hour...
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Fever, chills, nausea beginning about 6 hours after the vaccination and continuing for about 36 hours
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| 75 | 2021-01-10 | nausea |
Mild arm soreness at site the following day Significant fatigue on the following five days and now ...
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Mild arm soreness at site the following day Significant fatigue on the following five days and now Heart palpitations and elevated BP on day four Mild nausea on day five
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| 75 | 2021-01-14 | diarrhea |
feeling fatigue; "just not herself, out of whack in her body"; diarrhea; This is a spontaneous repor...
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feeling fatigue; "just not herself, out of whack in her body"; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as Pfizer-Biontech Covid-19 Vaccine; unknown lot number and expiration date), via an unspecified route of administration on 07Jan2021 at a single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient reported that she received the Covid 19 vaccine on 07Jan2021 then the day after (08Jan2021), she began feeling fatigue, "just not herself, out of whack in her body", and diarrhea. The patient reported that she was fine now. She inquired if those were normal. The outcome of the events was recovered on Jan2021. Information on the lot/batch number has been requested.
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| 75 | 2021-01-15 | nausea | Vertigo, dizziness, nausea no treatment except Dramamine so far |
| 75 | 2021-01-17 | decreased appetite, nausea |
Pt. states gradually experiencing severe nausea getting worse each day causing problem eating . P...
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Pt. states gradually experiencing severe nausea getting worse each day causing problem eating . Pt. concerned regarding symptom because they are prolonged and worsening. Pt. states due to ALS and other conditions needs to eat to to keep weight up .
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| 75 | 2021-01-18 | nausea, diarrhea, vomiting |
Chills, nausea, vomiting , diarrhea Then all day. Very ?deep? sleep. Then extreme dehydration. So ...
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Chills, nausea, vomiting , diarrhea Then all day. Very ?deep? sleep. Then extreme dehydration. So to ER for fluids. Don?t know how to go back. Original start of the event date was 01/14/2021. In am
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| 75 | 2021-01-20 | nausea, vomiting |
Severe headache; Nausea; Throwing up; I got so sick; Body ache; I was in pain everywhere; This is a ...
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Severe headache; Nausea; Throwing up; I got so sick; Body ache; I was in pain everywhere; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EK5730), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunisation. Medical history included migraine, depression, AFib, COVID-19 in Jun2020, and sleep disorder. Concomitant medications included prednisolone, ciprofloxacin, warfarin, timolol, sleep medications (unspecified), and eye drop (unspecified). The patient experienced body ache; stated that she was in pain everywhere on ; severe headache, nausea, throwing up, The patient stated that she felt like she had COVID all over again. She got so sick. It was reported that she worked for a clinic (also reported as a hospital) and on Friday (08Jan2021), she got the COVID shot. By Friday evening, she had body ache, and by Saturday, she was in pain everywhere. She also had severe headache, nausea, and was throwing up on 09Jan2021. According to her, the whole thing felt like she had COVID all over again and this went on through yesterday, she still had the headache today and some nausea. She stated that they were supposed to report this. When further clarified, the patient stated that she was tested yesterday again, just because it felt like COVID and because she had COVID way back in June last year. Stated that it felt like that all over again. She went to the [unclear statement], after hours to urgent care yesterday, they tested her again for COVID. She did not have COVID, she was clear, she was negative for COVID. Stated that she now knows that's what she has was just a result to the shot. When probed to clarify if it was the first dose or the second dose, the patient stated that she was just calling to ask. According to her, she was due to have it, the 29 (not clarified). She doesn't know if she should do it, she got so sick, she had been throwing up and everything. The patient was inquiring if she should do the second dose. The patient stated that she was about 150 lbs. and she does get her INR checked. As treatment, the patient took Tylenol and then took Zofran for the nausea. Outcome of the events 'Severe headache' and 'Nausea' was not recovered, while for the other events was unknown.
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| 75 | 2021-01-21 | abdominal pain upper |
Minor headache, stomachache, resolved in less than 30 minutes. Vital signs measured, blood pressure ...
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Minor headache, stomachache, resolved in less than 30 minutes. Vital signs measured, blood pressure 163/117, repeat in 15 minutes without intervention on a different blood pressure measuring device was 150/87.
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| 75 | 2021-01-22 | nausea |
01/15 Evening of injection developed headache; took 1 Aleve at 9:30 pm. Went to bed at 10:00 pm an...
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01/15 Evening of injection developed headache; took 1 Aleve at 9:30 pm. Went to bed at 10:00 pm and woke at 3:00 am on 1/16 with headache and nausea. At 7:00 am and all day remained in bed with headache, nausea (unable to eat or drink until evening when I had water, 1 scrambled egg and 1 piece of toast), fatigue. My arm was mildly sore at injection site. On 1/17 nausea, chills resolved. Headache better. Fatigue better but remained for about 3 days.
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| 75 | 2021-01-24 | diarrhea, nausea | headache,nausea,diarrhea,arm swelling. fatigue |
| 75 | 2021-01-26 | diarrhea |
Covid vaccine on 1/19. Took Enbrel injection for RA on 1/19 evening. On 1/21, pt experienced diarrhe...
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Covid vaccine on 1/19. Took Enbrel injection for RA on 1/19 evening. On 1/21, pt experienced diarrhea. Has had diarrhea after Enbrel before, but not to this degree.
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| 75 | 2021-01-26 | nausea |
On 1/26/21 client went to her exercise class at 5:30am, she became extremely cold, clammy, nauseated...
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On 1/26/21 client went to her exercise class at 5:30am, she became extremely cold, clammy, nauseated, and said she couldn't sit up. She called her husband to come and pick her up. She was afebrile. Blood sugar was 86. She said she just wanted to sleep. She sleep most of the day and through the night until 3:30 am today. She woke up and said she feels fine. She said at one point her body felt frozen and she couldn't move at all.
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| 75 | 2021-01-27 | nausea |
Dizziness; history included compromised immune status; history included compromised immune status; g...
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Dizziness; history included compromised immune status; history included compromised immune status; getting really tired/fatigue; Gets real sweaty; chills; almost passed out at doctor's office; Nausea; Felt cold; Blood in urine; Feeling unwell; Feeling bad; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EJ1686), intramuscular in the left upper arm on 08Jan2021 at 15:45 at 0.3 mL, single for COVID-19 immunization. Medical history included Leighten Plantar Alopecia (hair follicle is an enemy), skin infection (infection in body most of the time, at least on skin), diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities, obesity, autoimmune disorder (diagnosed 8 months ago). She has lost some height, prior to taking the vaccine and she said it was related to age. There were no concomitant medications. The patient experienced feeling unwell on 10Jan2021; blood in urine on 10Jan2021 at 17:00; nausea at 10:00, chills at 11:00, almost passed out at doctor's office at 10:00, felt cold - all on 11Jan2021; getting really tired/fatigue on 14Jan2021 at 09:30; gets really sweaty on 13Jan2021 at 10:00; and dizziness on unknown date. The patient had the first shot on Friday (08Jan2021). On Sunday (10Jan2021), she started feeling bad. She was feeling good about getting it and had no reaction. She has an autoimmune disorder that made her a little afraid to take, but with all the indications, they said it would be much better for her to take it than to get the COVID virus. Sunday (10Jan2021), she does not feel good. So, she started having blood in urine. She thought she had a UTI and had not had one in 20 years. It felt like that is what she had and with the blood in urine. She just took Tylenol and waited until Monday morning because she does not like sitting in doctor's office. They gave her a cup to give sample and said she didn't need to see provider. They will have it checked and in the meantime call in a prescription. It kept getting worse and worse. She was about to passed out in the doctor's office on 11Jan2021, she got nauseous and almost threw up. She got in the car with her husband and he was trying to get her home. She got chills and got so cold and could not warm her body up. Her husband gave her Phenergan and it kind of knocked her out for a while to ease her nausea. She was thinking of going later today (14Jan2021), when she gets enough energy, to get a COVID test. She does not know if it will give false positive or not. She had chills and now she gets sweaty since 13Jan2021. She took her temperature and she did not have one. She just now got up. It is 10:00. She got up this morning (14Jan2021) and was really tired. She was not sweating this morning. Tiredness is kind of new, and when she talked to the nurse, she sort of felt like maybe it was a reaction to the COVID vaccine, but then she talked to her daughter and she said the symptoms she was having are usually symptoms that occur with second dose of the vaccine. It is not uncommon for people to have symptoms she was having. She wanted to know if she should have a COVID test. If she has had just one shot, would the test give a false positive coming from the COVID. They were asking if patient should take the second dose, and should she continue her UTI medication. Doctor's visit to give urine sample on 11Jan2021 (results: negative for UTI). She did not see a doctor though. They sent sample and prescribed a sulfa based medication for a UTI. She did start feeling a little better and stopped having blood in her urine. She plans to continue it because she does not like to stop taking an antibiotic. She did not have any clue that it was not a UTI until the nurse from her provider's office called to tell her results of urine sample was negative. Outcome of event getting really tired/fatigue was not recovered; events almost passed out at doctor's office, blood in urine, chills, and gets really sweaty was recovering; and unknown for other events.
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| 75 | 2021-01-28 | nausea, vomiting |
Started with injection site Hurting, Developed tiredness, light headache, hurting all over, had chil...
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Started with injection site Hurting, Developed tiredness, light headache, hurting all over, had chills for 3 nights fever range from 100 degrees up to 103.8, had nauseau and vomited one day, my face- looked a little swollen and cheeks were pink, was in bed mostly for 13 days. Called My Doctor after about 4 days , he prescribed MethyIIPredisolone 4 mg tablets, seems to bring fever down and stop chills, still feeling really bad, went to Urgent Care and they did Covid Test which was Negative, had virtual call with their doctor , and they prescribed a "Z Pak" Did not stated feeling better until 13 day. When taking Predisone, I started having chest pains, when I only had 4 more pills to take. Had to take 2 Nitro and discontinued Predisone. Still weak and tired.
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| 75 | 2021-01-28 | nausea, vomiting |
Patient states feeling nausea vomiting. BP 206/93 pulse 90 spo2 98% at 4:05 PM repeated BP 209/88 P...
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Patient states feeling nausea vomiting. BP 206/93 pulse 90 spo2 98% at 4:05 PM repeated BP 209/88 P 94 Sao2 98% Transferred to urgent care via w/c. Warm handoff given to urgent care staff.
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| 75 | 2021-01-29 | retching, nausea |
4:30 - 6:30 pm on 1/29/2021 nausea, chills, dry heaved, bowel purge (not diarrhea) No treatment -sle...
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4:30 - 6:30 pm on 1/29/2021 nausea, chills, dry heaved, bowel purge (not diarrhea) No treatment -slept Fine after this event but tired
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| 75 | 2021-01-30 | nausea, vomiting |
Pfizer-BioNTech COVID-19 Vaccine EUA. Adverse events: chills, joint and muscle pain, nausea and vomi...
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Pfizer-BioNTech COVID-19 Vaccine EUA. Adverse events: chills, joint and muscle pain, nausea and vomiting. Events decreasing after one day.
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| 75 | 2021-01-30 | vomiting | fast heartbeat, itchy throat, vomiting |
| 75 | 2021-01-31 | nausea | Chills, nausea, fever(102) Saturday except for temperature of 100 all symptoms were gone. |
| 75 | 2021-02-01 | diarrhea, nausea |
explosive diarrhea that was liquid and green in color; explosive diarrhea that was liquid and green ...
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explosive diarrhea that was liquid and green in color; explosive diarrhea that was liquid and green in color; feeling "queasiness"/queasy abdomen; loose bowel movement; a queasy abdomen right now, kind of gurgling; This is a spontaneous report from a contactable consumer (patient) and nurse. A 75-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140, expiration date 31Mar2021), intramuscularly at site of left arm on 18Jan2021 09:30 AM at single dose for prevent COVID. The patient medical history was not reported. There were no concomitant medications. The patient previously received flu shot in Oct2020 for immunization (she had the flu shot last year but it was not within 4 weeks, it was in the fall time around Oct2020). The patient experienced a loose bowel movement later in the day on 18Jan2021 (after the vaccine dose) and reported that on 19Jan2021 she was having explosive diarrhea that was liquid and green in color. Also reported feeling queasiness. She known about the reported side effects of the clinical trials. She asked if she could get a colonoscopy next day and she was referred to her hcp. She just had a queasy abdomen right now, kind of gurgling in Jan2021. All events were reported as non-serious. The patient did not receive any treatment from events. The outcome of event bowel movement irregularity was recovered in Jan2021, the outcome of events explosive diarrhea and greenish stool was recovered on 19Jan2021, the outcome of rest events was not recovered.
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| 75 | 2021-02-01 | nausea |
Nausea, headache, fatigue, lung tightness, muscle heaviness, foggy brain (lack of concentration and ...
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Nausea, headache, fatigue, lung tightness, muscle heaviness, foggy brain (lack of concentration and focus) , GI Increase in bowel movements, general malaise. These symptoms have lasted 6 days so far at varying intensity The lung tightness occurred on day 1 and day 4. The nausea has been persistent. The headache was on day 1 and 3. Foggy brain on day 2 and 5. Fatigue everyday. I am concerned about getting the second shot
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| 75 | 2021-02-02 | nausea |
Pt reported mild nausea and dizziness shortly after vaccine administered. Symptoms resolved in 5min ...
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Pt reported mild nausea and dizziness shortly after vaccine administered. Symptoms resolved in 5min without intervention. VSS. DC home NAD.
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| 75 | 2021-02-04 | diarrhea |
diarrhea; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female ...
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diarrhea; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received bnt162b2 (BNT162B2, lot number EL3302) , via an unspecified route of administration on 21Jan2021 12:00 at single dose on left arm for covid-19 immunisation. Medical history included none. Concomitant medication included citalopram hydrobromide (CELEXA), zolpidem tartrate (AMBIEN). No other vaccine in four weeks. The patient experienced diarrhea on 22Jan2021 08:00. No treatment received. No covid prior vaccination, no covid tested post vaccination, no known allergies. The outcome of the event was not recovered.
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| 75 | 2021-02-04 | vomiting, nausea |
severe chills; Fever; Dizziness; not feeling quite right; heart pains; Nauseated; threw up; Tirednes...
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severe chills; Fever; Dizziness; not feeling quite right; heart pains; Nauseated; threw up; Tiredness; muscle aches; a little swelling in her face; weakness; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EK5730) intramuscularly on arm left on 09Jan2021 10:00 at a single dose for COVID-19 immunization. Medical history included heart problems from May1966 and ongoing (heart problems/She had open heart surgery at that time and had stents put in a couple of times since then), bone spurs and arthritis in her feet. Concomitant medications were none. Patient used to receive unspecified injections in her feet because she has bone spurs and arthritis in her feet. Patient experienced heart pains in Jan2021, dizziness on 10Jan2021, not feeling quite right on 10Jan2021, severe chills on 11Jan2021, fever on 11Jan2021, nauseated in Jan2021, threw up in Jan2021, tiredness in Jan2021, muscle aches in Jan2021, a little swelling in her face in Jan2021, weakness in Jan2021. The outcome of the events was unknown. Patient received her first Pfizer vaccine on 09Jan2021. Patient explains she has had adverse reactions to the vaccine ever since she received it. Patient confirms she took the vaccine on Saturday, 09Jan2021. On Sunday, 10Jan2021, she started having a little bit of dizziness and feeling just not quite right. Sunday night, she went to bed and woke up at around 3:30 a.m. with severe chills and a fever. Her fever was a little over a 100. She states it took about 2 hours to get her chills under control. She took 2 Tylenol at that time. That day (11Jan2021) she ran fever off and on all day. The next day (12Jan2021), she seemed to be better. She had a low-grade fever, but she was better. She was just kind of tired from the day before. But then, that night, she ended up with the same thing again- she woke up at 4am with chills. Her fever had gone up 101.7, and she ended up taking 2 Tylenol and so forth. She got up that morning around 10 am, and was nauseated. She threw up that morning. She felt really bad. She was experiencing tiredness, muscle aches. (At this point it was about Tuesday (12 Jan) or Wednesday (13 Jan). There was one day during the day, she felt better, but a day went by and she ended up having the chills and fever again. Every time her fever kept going up. Her fever this particular night was 102 something. About Wednesday night, when she had the chills and fever, her fever went up to 103.8. That next morning, she called her doctor's office and tried to get an appointment. She could not get an appointment with the office. Her office ended up doing a televist and sending her a Prednisone pack to take for the reaction that it seemed she was having. She started the prednisone pack which seemed to take the fever down and the chills ended up stopping. Caller clarifies further she believes she has recovered from the fever and chills. The Prednisone pack seemed to kind of make those symptoms go away. However, she still felt really bad. This went on all weekend again. Tuesday of this week, (19Jan2021), she still felt really bad. She called her doctor again and her doctor wouldn't see her because of the symptoms she is having after receiving the COVID-19 vaccine are the same symptoms of the actual COVID-19 virus. She clarifies further the adverse effects of the shot are also same ones as the COVID-19 virus. Her doctor suggested she either go to the Emergency Room or to an Urgent Care. Patient called the Urgent Care and they were able to do a COVID test on her to check and see if she did have COVID-19. She confirms this test was on Tuesday, 19Jan2021. The results came back negative. However, they did another swab test. The patient is unsure what the second swab test was for but was told it would be a couple days before they would have the results of this test. At this point, they put her on a Z-pak. Patient mentions she has heart problems. She has nitroglycerin for any problems that she has. She started having some heart pains when she was down to about 3 tablets of that Prednisone pack she was taking. When she took one of the Prednisone tablets, within 30 minutes of taking it, she started having chest pains. She clarifies it started in her throat and went down to her chest. She took 2 nitroglycerin's to get her feeling back to normal/better. Caller doesn't provide NDC, Lot number or expiration date for the Nitroglycerin she took when probed. Patient mentions her cheeks had been pink. She doesn't really know but she may have a little swelling in her face. She can't figure that out herself. She was experiencing dizziness and weakness. Today is the first day which is the 13th day after receiving the vaccine, she has felt like trying to get this stuff together and her thoughts together to try and figure out what is going on with her. She tried calling her primary doctor and this urgent care and she couldn't get anybody to see her. Patient got her Prednisone pack filled at (Pharmacy name), (Address details) The prescription was issued to her on Thursday, 14Jan2021, but she didn't start taking the pack until Saturday. On Saturday, that's when her fever had went up to 103 and she knew she needed to take the Prednisone pack. They are 4mg tablets and she started out taking 6 tablets the first day and then her dose decreased every day. NDC: 164793723369, Lot: 20K0041P, she believes the second digit is a zero and not a "D", Expiry date: Aug2022. Z-pak: patient states she no longer has the box, therefore she is not sure of the dose and how it was prescribed. She makes the comment she believes the first day it was 2 tablets. NDC: Unknown, Lot: 7996030, Expiry: Feb2022. She clarifies she did not take Tylenol as stated earlier. She took Kirkland's brand, Acetaminophen. They are 500mg tablets. She provides the following product information: Lot: 2GE1779B. The last digit is either a "B" or an 8/, Expiry date: May2015; patient clarifies she knows they just bought this bottle, but she thinks her husband put his extra pills in the wrong bottle. No further details were provided or obtained in regard to this statement. The patient wants to find out about this and what is going on with her. To her understanding and her reading information, she is scheduled to take her next shot 27Jan2021. She is not supposed to take it then, correct? Investigations: patient confirms she had a COVID-19 test done (she is not sure what type of test- PCR, Antibody, etc), they swabbed her nose and the results came back negative. She had a second test done, where they swabbed her nose again, but she hasn't got the results back. She isn't sure what that test is for. Vaccination Facility Type was Hospital. Additional Vaccines Administered on Same Date of the Pfizer Suspect was no. Did any AE(s) require a visit to: Emergency Room was No, she is trying to keep herself out of the hospital. Physician Office? Her doctor would not see her but offered a virtual visit. She did go to the Urgent Care. Prior Vaccinations (within 4 weeks): Caller states she went to the foot doctor on 22Dec2021 (pending clarification). She was given injections in her feet because she has bone spurs and arthritis in her feet. Patient does not know exactly what kind of injection it was. She confirms she has no name, ndc, lot and expiry date for the injections she received. Patient asks the call handler, what should she have done on this? She was lost. She read the information that was provided to her and she doesn't feel there was sufficient information on what to do if you had a reaction. She guesses the best thing she can be told is to call #. She didn't know it was a # emergency. She didn't know what she was supposed to do. It was hard for her to get any information out of anybody as to what to do. The outcome of the events was unknown.
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| 75 | 2021-02-05 | nausea, abdominal pain |
I woke up feeling sick with headache and pain in abdomen, went to bathroom and sat down, I was burni...
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I woke up feeling sick with headache and pain in abdomen, went to bathroom and sat down, I was burning up and perspiration was dripping down my body, i felt like i might throw up and that was the last though until I came to on the floor of our walk in shower. It took me a while to orient myself and get up and sat down again on toilet still with pain in head and disoriented. next thing i know i am coming to wedged between the toilet tank and the vanity. I managed to get back on the toilet and sat there wondering what was happening to me. I could tell i was getting better so i just sat there a while longer until i though my legs would hold me so i could get back to the bed. I laid in bed the rest of the night unable to sleep with headache and shivering with being cold even under my blankets. I stayed in bed Saturday then called the doctor first thing Monday morning. I got in to see her at 10:30 Monday morning. She ordered a full blood panel and urinalysis and heart monitor for 48 hours. The blood panel and urinalysis reports are all ok. Have not received report yet from the heart monitor. Doc said I cannot take the second shot.
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| 75 | 2021-02-05 | nausea, decreased appetite |
Dizzy, light-headed, unable to balance, fever, lack of appetite, chills, slight nausea for about 36 ...
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Dizzy, light-headed, unable to balance, fever, lack of appetite, chills, slight nausea for about 36 hours Tylenol 2x500mg
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| 75 | 2021-02-07 | abdominal discomfort |
Very tired & intense joint pain all night. Next day, chills & flu like symptoms (a very upset stomac...
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Very tired & intense joint pain all night. Next day, chills & flu like symptoms (a very upset stomach) After 48 hours, side effects disappeared completely.
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| 75 | 2021-02-07 | diarrhea |
Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female p...
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Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3248), via an unspecified route of administration on 14Jan2021 14:00 at single dose at left arm for covid-19 immunization. Medical history included thyroid disorder, irritable bowel syndrome diarrhea, colitis microscopic, low B12, low D, diarrhoea. Concomitant medication included levothyroxine for thyroid disorder, calcium, magnesium for colitis microscopic, cyanocobalamin (VIT B12) for low B12, vitamin d3 for low D, polycarbophil calcium (FIBERCON) for irritable bowel syndrome diarrhea, bifidobacterium infantis (ALIGN) for irritable bowel syndrome diarrhea, loperamide from May2020 for diarrhea, TRI Adrenopan for loss of adrenal function, multivitamin for losing vitamins; all ongoing. Right away after getting the vaccine, during the wee hours of the morning between 14Jan2021 and 15Jan2021 she got very severe diarrhea. Mentioned she previously had microscopic colitis so she was used to having some diarrhea so she didn't remember exactly the time in the night. Adds since that night she had been having six liquid stools a day. She was having to wear depends and can't go out of the house. Patient microscopic colitis was under control but now she had real bad diarrhea for seven days. Originally they thought she had IBSD, referring to irritable bowel syndrome diarrhea, but then they found out it was microscopic colitis. This condition predated treatment with Pfizer COVID 19 vaccine. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. The event required contacting the gastroenterologist and primary care by the portal. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of event was not recovered.
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| 75 | 2021-02-08 | diarrhea, vomiting |
Diarhea, vomiting, chills, sweats, mild rash all over the body, injection site pain and swelling, mu...
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Diarhea, vomiting, chills, sweats, mild rash all over the body, injection site pain and swelling, muscle soreness.
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| 75 | 2021-02-09 | nausea |
nauseated; Rash/all over her body/I woke up in a rash and yesterday it was worst; allergic reaction ...
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nauseated; Rash/all over her body/I woke up in a rash and yesterday it was worst; allergic reaction to something because she just woke up in a rash it didn't itch; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3249) injected via an unspecified route of administration in the left arm, on 22Jan2021 at single dose for COVID-19 immunisation. Relevant medical history included blood pressure (disorder). Concomitant medications included losartan for blood pressure, montelukast, estradiol (ESTROGEN), metoprolol, esomeprazole, rosuvastatin calcium (ROSUVA). Patient got the COVID vaccine on Friday (22Jan2021), Saturday (23Jan2021) started breaking out in a rash, all over her body. She woke up in a rash and yesterday (24Jan2021) it was worst and she was nauseated; she was having allergic reaction to something because she just woke up in a rash it didn't itch (Jan2021). This was her first dose of the vaccine. She didn't get the vaccine from her doctor, she called into the hospital, the hospital was giving them out on Friday (pending clarification). She was wondering if there is any way she can get something for the rash. Patient did not have treatment for the events. Outcome of rash was not recovered, outcome of other events was unknown.
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| 75 | 2021-02-10 | abdominal pain | Systemic: Fever, Systemic: Abdominal Pain |
| 75 | 2021-02-10 | nausea, diarrhea, vomiting |
muscle aches; nausea; vomiting; weakness; chills; Diarrhea; Joint pain; It scared me that I was so s...
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muscle aches; nausea; vomiting; weakness; chills; Diarrhea; Joint pain; It scared me that I was so sick.; Slight headache like a little pressure on her head / Horrible headache; This is a spontaneous report from a contactable consumer (patient). A 75-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number EL9262 (the patient was not sure of the second letter), via an unspecified route of administration in left arm on 23Jan2021 at 16:15 at single dose for COVID-19 immunization. Medical history included sinus infection. The patient was not pregnant at the time of vaccination. Facility where the COVID-19 vaccine was administered was Hospital. The patient has not been tested for COVID-19 since the vaccination. Concomitant medication included amoxicillin, clavulanic acid (AUGMENTINE) for sinus infection and pravastatin. The patient stated that when she went home after vaccination, she had a slight headache, like a little pressure on her head when she went to bed but that was supposed to be normal. So, she went to sleep and the next morning she woke up and she had every single side effects: the nausea was horrible, she must have thrown up 15 times, she had diarrhea and joint pain. She did not think she had any fever but she did had chills and muscle pain, weakness and had horrible headache. The events onset date was reported as 24Jan2021 at 12:00 AM (except for headache which started on 23Jan2021). No treatment was administered for these events. The patient stated that it scared her that she was so sick. All the reported events were assessed as non-serious. The patient reported that 3 days later she was still feeling very weak. At the time of the report the events headache, muscle aches, nausea, vomiting and chills had recovered with sequelae, the event weakness had not yet resolved, whereas the outcome of the events diarrhea, joint pain and sickness was unknown.
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| 75 | 2021-02-10 | nausea |
terrible aches all over; headache; there is something wrong with her smell/she can smell but things ...
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terrible aches all over; headache; there is something wrong with her smell/she can smell but things do not smell right; She has chills really bad; felt really awful; nausea; She had a fever; dry cough; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982 and expiry date:31May2021), via an unspecified route of administration on the left arm, on 22Jan2021 10:45 at a single dose for COVID-19 immunization. Medical history included atrial fibrillation from Nov2019, heart attack 2016, stent placed from 2016, and cardiac ablation from Aug2020. There were no concomitant medications. Patient had her first dose on 22Jan2021 and she felt all the side effects like nausea, fever, chills, headache on 24Jan2021 and wanted to know if that is normal. She also experienced dry cough on Jan2021. Patient reported she was fine and did not even feel it. She was fine that day and the next day. By the third day she started getting every symptom in the world. The one that really bothered her, and she cannot find any information on it was the dry cough. She was asking if dry cough is a reported side effect. She further clarified that the dry cough started either the same day she received the vaccine or the next day and all her other symptoms started on Sunday afternoon (24Jan2021). She had a fever and still has fever at the time of report, and had improved slightly since she takes Tylenol every 6 hours which was keeping the fever at bay. But her temperature was still over 100. She had terrible aches all over which has slightly improved and a headache (she does not think she has one now), and stated it had improved. The nausea was off and on and there was something wrong with her smell. She can smell but things do not smell right. She smelled something like gasoline earlier but she knew it was not gasoline. She thought about food and she wanted to gag, and her taste seems ok. She has chills really bad and clarified all symptoms aside from the dry cough started Sunday around 4 in the afternoon. She felt really awful and took her temperature and it was 101 on Jan2021. The chills are off and on and when her fever goes up, then her chills go up. Outcome of the events of nausea, chills and felt awful was unknown, for events dry cough and something wrong with smell was not recovered, and for the remaining events was recovering. Patient was asking if she somehow contracted covid in between getting her vaccine and now. She had a negative covid test a long time ago when she was going to have procedures done. She confirmed she has not had a covid test recently and stated it was just seems weird since she felt fine right after getting the covid shot.
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| 75 | 2021-02-10 | vomiting |
started to throw up, was vomiting; This is a spontaneous report from a contactable consumer (patient...
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started to throw up, was vomiting; This is a spontaneous report from a contactable consumer (patient herself) via Medical Information team. A 75-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on the left arm (reported as left upper arm) on 23Jan2021 at 11:00 at a single dose for COVID-19 immunization. The vaccination facility type was reported as the clinic. The patient had no medical history. She had no family medical history relevant to the adverse event (AE). The patient's concomitant medications were not reported. The patient did not receive any other vaccines that day. She did get a flu shot maybe a month prior reporting or longer and again mentioned she had no problems with vaccines in the past. She did remember getting a pneumonia shot and another one that she did not remember the name of. She got flu shots every year. The patient had no history of previous immunization with a Pfizer vaccine. The patient explained she experienced vomiting 12 hours after the injection of the first dose of the COVID-19 vaccine. She asked if her symptom was a reported side effect for the vaccine. She also asked how to avoid this experience after the second dose of the vaccine. It was further reported that on 23Jan2021 at about 23:00, when she went to bed, she felt like going to the bathroom. She sat down and started to throw up, she was vomiting, and it came so fast without warning. She made a mess and had to take another shower. This was 12 hours after getting the vaccine and the first time she had ever had this happen. She got a flu vaccine every year, since her husband was a nurse and told her to get vaccinated, but she had never had this to happen with any other vaccine in past. This was her first reaction to anything. The patient was asking if this happens to other people. She had been fine since that had happened, but she didn't have any warning and didn't feel nauseous. She had the sheet and it said you could experience nausea, but she didn't. She even checked with her daughter, son-in-law, and grandson who she ate dinner with and no one else was sick and so they think it's the vaccine and didn't come from something they ate. She had to go back in 3 weeks and was given the sheets/paperwork. The patient also reported that she did wait there at least 15 minutes after getting it to make sure no bad reactions occurred immediately afterwards and she didn't and she figured she wouldn't. The patient thought this one was different. The AE did not require any visit to an emergency room or a physician office. The patient had no relevant tests or investigation assessment. The patient was recovering from the event. Information on the batch/lot number has been requested.
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| 75 | 2021-02-11 | vomiting, nausea |
On 2/7/21 resident complainted of not feeling well, nausea, vomiting and weakness sent to ER passed ...
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On 2/7/21 resident complainted of not feeling well, nausea, vomiting and weakness sent to ER passed away.
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| 75 | 2021-02-14 | nausea |
sore throat; headache; don't feel well; weak; nauseated; hoarse; she feels tired; her mind is just k...
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sore throat; headache; don't feel well; weak; nauseated; hoarse; she feels tired; her mind is just kind of foggy; This is a spontaneous report by a contactable consumer (patient). This 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL3247), via an unspecified route of administration at single dose in the left upper arm on 20Jan2021 07:30 for Covid-19 immunisation. Medical history none. There were no concomitant medications. The patient experienced headache on 26Jan2021 with outcome of unknown, don't feel well in Jan2021 with outcome of unknown, weak in Jan2021 with outcome of unknown, nauseated in Jan2021 with outcome of unknown, sore throat on 28Jan2021 with outcome of not recovered, hoarse in Jan2021 with outcome of unknown, she feels tired in Jan2021 with outcome of not recovered, her mind is just kind of foggy in Jan2021 with outcome of unknown.
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| 75 | 2021-02-15 | nausea, diarrhea |
Fever bet. 100 and 101 for 4 days, plus diarrhea, chills, nausea, tired, sleepy; Dr. was contacted ...
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Fever bet. 100 and 101 for 4 days, plus diarrhea, chills, nausea, tired, sleepy; Dr. was contacted by husband; recommended going to emergency room if I got worse.
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| 75 | 2021-02-15 | nausea |
Received Pfizer vaccine at 1:00 p.m. on Friday 2/12. Mild headache at 10:00 p.m. Friday evening, 9 h...
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Received Pfizer vaccine at 1:00 p.m. on Friday 2/12. Mild headache at 10:00 p.m. Friday evening, 9 hours after vaccine. Awake at 2:00 a.m. with nasty headache and 102.5 fever. Fever and headache continued throughout the next day with fever diminishing to 101.7 and later 99.9 Fever subsided after 20-24 hours. Headache and mild nausea continued but diminished gradually through Sunday and into Monday a.m. At 72 hours symptoms are basically gone, but left very tired.
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| 75 | 2021-02-15 | vomiting |
What I know so far is they gave her the shot her heart stopped for about 3-4 minutes they did cpr un...
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What I know so far is they gave her the shot her heart stopped for about 3-4 minutes they did cpr until the ambulance got there they took her to main. They are going to do a bunch of test . They are going to keep her she has too see the cardiologist they are going to do an eco cartogram and an ultrasound of her heart. They had to my mom on a ventilator because they where putting the defibrillator in and she started throwing up and they had to do compression again cause her heart stopped again and she stopped breathing
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| 75 | 2021-02-18 | nausea |
Patient described feeling of warmth, facial flushing, tremors, nausea, tingling in roof of mouth and...
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Patient described feeling of warmth, facial flushing, tremors, nausea, tingling in roof of mouth and hands 30 minutes following vaccine.
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| 75 | 2021-02-21 | loss of appetite |
Patient was admitted due to confusion and poor oral intake most likely due to esophageal spasm. Pt r...
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Patient was admitted due to confusion and poor oral intake most likely due to esophageal spasm. Pt remains hospitalized at this time
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| 75 | 2021-02-22 | difficulty swallowing | Sensation of swelling in throat and difficulty swallowing |
| 75 | 2021-02-23 | decreased appetite |
Bell's palsy; blood pressure increased; chest pain; breathing difficulty; weakness; tired; loss of a...
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Bell's palsy; blood pressure increased; chest pain; breathing difficulty; weakness; tired; loss of appetite; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of bnt162b2 (lot number: EL9262), via an unspecified route of administration, at arm left, on Jan2021 at single dose for COVID-19 immunisation. Medical history included Prediabetes from 2019 (reported as diagnosed two years ago), overweight from an unknown date, ongoing arthritis from 2017 (reported as about 4 years ago), gets worse now. There were no concomitant medications. Caller states she just has a question, states she took the test about 2 weeks ago, clarifies the Pfizer vaccine and due for next one on Sunday, caller wanted to find out if what she experienced could be due to the vaccine, states she had a reaction for almost two weeks (also reported that all the events started on 05Feb2021, pending clarification), states her blood pressure went up, she had chest pain in her chest, weakness, loss of appetite, states it lasted about 24 hours, no exact dates provided. Also experienced Bell's Palsy states it comes and goes, that when she talks the saliva comes down the side of her mouth. States her Blood pressure went really high, 145/90 or so, lasted about 24 hours. Did not know if she was having a heart attack. Does see a cardiologist because of a family history of cardiac issues. The outcome of the event Bell's Palsy was not recovered, of the other events was recovered on Jan2021 (reported as lasted for 24 hours).
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| 75 | 2021-02-23 | diarrhea, nausea |
flu like symptoms; diarrhea; severe/bad headache; nausea; This is a spontaneous report from a contac...
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flu like symptoms; diarrhea; severe/bad headache; nausea; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; lot number: EL9261; expiry date: unknown) at the age of 75 years old, via an unspecified route of administration in the right arm, on 23Jan2021 09:00, at a single dose, for COVID -19 immunization. The patient had no relevant medical history and was not taking concomitant medications. Patient reported that she got the Pfizer Covid vaccine shot on 23Jan2021 at 9:00. On 24Jan2021, about 2:00, the next morning, she felt like she got hit by a bus further described as flu like symptoms including nausea, diarrhea, and a severe/ bad headache. The events were treated with Phenergan at home. These symptoms lasted about a day; patient completely recovered on 25Jan2021.
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| 75 | 2021-02-23 | nausea | Head ache, nausea |
| 75 | 2021-02-23 | vomiting, nausea |
Got the vaccine, and on 2/22/21 she woke up at 2-3:00 AM with violent vomiting, two episodes. Her a...
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Got the vaccine, and on 2/22/21 she woke up at 2-3:00 AM with violent vomiting, two episodes. Her arm was sore, still having nausea. She feels like she is going to throw up still, 2/24/21. She has not taken anything for the symptoms.
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| 75 | 2021-02-24 | difficulty swallowing |
Within 15-minutes of vaccination, the patient reported difficulty swallowing, No difficulty breathin...
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Within 15-minutes of vaccination, the patient reported difficulty swallowing, No difficulty breathing, pain, or other complaints voiced. EMS evaluated the patient on-site. The patient was hypertensive (208/103). EMS noted that the patient was visibly anxious and that they elected to be transported to Emergency Department for evaluation. When contacted for medical records, ED stated that the patient never was checked into the hospital and did not have records available. Assumed lost to follow-up.
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| 75 | 2021-02-25 | burping |
Patient had COVID shot on 2/5/21 Friday afternoon and waited her observation period. She started hav...
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Patient had COVID shot on 2/5/21 Friday afternoon and waited her observation period. She started having a sharp chest pain on drive home. She pulled over and the feeling went away. No other symptoms. On sat morning patient started getting twinges of chest pain on left side bottom by her breast. On Saturday night and Sunday morning patient started belching. She doesn't normally have belching. This morning patient felt like her heart racing. She is still having a chest pressure. Was sent to ED 2/8/21 after triage. Labs unremarkable, troponin negative, instructed to f/u with PCP, discharged in stable condition. F/U w/ PCP 2 weeks later and reported weight loss, weakness, possible facial droop (although not noticed today on exam). Symptoms appear to be improved.
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| 75 | 2021-02-25 | nausea, decreased appetite, constipation |
Vaccinated on Saturday, woke up Sunday with ringing ears, general malaise, dizziness, stuffed up sin...
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Vaccinated on Saturday, woke up Sunday with ringing ears, general malaise, dizziness, stuffed up sinuses, red burning eyes, constant sneezing and dripping nose, weak and shaky on my feet. Lose of appetite, constipation and nausea.. It lasted for 4 days and on Wednesday I called my medical care giver and she said that I probably had an allergic reaction to the vaccine and to not take the next dose, as this had been my first. I am still, periodically week and dizzy, and still have little appetite.
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| 75 | 2021-02-25 | vomiting |
After vaccine, the next day 3-4am woke up with horrible headache, slight fever, sweaty. injection si...
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After vaccine, the next day 3-4am woke up with horrible headache, slight fever, sweaty. injection site raised and red and still is, also has trouble keeping liquid or food in. Still gets fleeting headaches and sweats ever morning.
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| 75 | 2021-02-27 | abdominal pain |
Tingling /numb hands and feet, tired, no energy, night sweats, abdominal pain, burning on bottom of ...
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Tingling /numb hands and feet, tired, no energy, night sweats, abdominal pain, burning on bottom of feet, muscle weakness, dry mouth, joint pain, headache,...
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| 75 | 2021-02-28 | abdominal discomfort |
hurting in her chest, like she has to keep breathing; feeling kind of weird/ feeling bad; feeling ki...
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hurting in her chest, like she has to keep breathing; feeling kind of weird/ feeling bad; feeling kind of weird, off balance; Upset stomach; Chills; She cannot function very good, She is feeling so bad and cannot do nothing; At night time it is hard to try to do something and she cannot do it because she is tired; can hardly breathe at night; it kind of feels like she has an ear ache but she does not have an earache; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1283), via intramuscular route of administration on 14Jan2021 (at the age of 75-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included ongoing chronic obstructive pulmonary disease (COPD) from an unknown date (per patient diagnosed quite a while ago and she goes to a pulmonary doctor). Concomitant medications included unspecified inhaler at two puffs per day if needed and unspecified recue inhaler one puff a day as needed, both ongoing for one year for COPD. The patient did not receive any other vaccines within four weeks prior to the vaccination or any other prior vaccinations or any vaccinations on the same date of the vaccination. The patient experienced chest pain, feeling abnormal, feeling off balance, upset stomach, chills, cannot function very good, tired, can hardly breathe at night and ear discomfort, all in Jan2021. The patient reported she received the vaccination on 14Jan2021 by her primary doctor. She is feeling kind of weird and has an upset stomach. She is asking how long this will last. She is worried about taking the second dose. She is supposed to have the second dose on 04Feb2021. She cannot function very good, states it kind of feels like she has an ear ache but she does not have an earache. Her balance is off and she can hardly breathe at night. All her symptoms started on the third day after getting the shot (Jan2021). She reports the feeling weird and off balance feeling feel like you are drunk. It aggravates her because she cannot function right. She also experienced chills started the third day after the shot and the chills have recovered completely. The patient reported that she was alright the first day. She has hurting in her chest, like she has to keep breathing which also started the third day after getting the shot and has been going on all this time. At night time it is hard to try to do something and she cannot do it because she is tired, states it is the worst part, She is feeling so bad and cannot do nothing. She has a hard time breathing. The events did not require a visit to emergency room or physician office. The patient did not have any relevant tests. The clinical outcomes of the events chest pain, feeling abnormal, feeling off balance, upset stomach were not recovered. The patient recovered from the chills in Jan2021. The outcome of the cannot function very good, she is feeling so bad and cannot do nothing, tired, can hardly breathe at night and ear discomfort was unknown.
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| 75 | 2021-02-28 | decreased appetite |
Pt was brought to ED due to altered mental state, apparently after pt received first Covid vaccine, ...
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Pt was brought to ED due to altered mental state, apparently after pt received first Covid vaccine, she didn't feel quite well, fatigued; after recent 2nd Covid vaccine, pt had been noted to be confused with poor appetite. Pt also with recent dx hypopituitarism - has been on desmopressin/ prednisone - per report from family members, pt had been drinking a lot of water. In ED, Pt was noted with hyponatremia - NA 124, Lactic acidosis 2.1, low grade temp - PCT wnl.
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| 75 | 2021-02-28 | nausea |
On day after had severe muscle ache; severe headache; nauseous; so cold (could not get warm); had a ...
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On day after had severe muscle ache; severe headache; nauseous; so cold (could not get warm); had a fever; slept for 15 hours; This is a spontaneous report from a contactable consumer. A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9265), via an unspecified route of administration on 26Jan2021 17:00 at single dose for covid-19 immunisation. Medical history included mitral valve prolapse and COVID-19. Concomitant medication included bimatoprost (LUMIGAN), colecalciferol (D3), zinc (ZINC), and ubidecarenone (COQ10). The patient experienced severe muscle ache, severe headache, nauseous, so cold (could not get warm), had a fever and slept for 15 hours on 26Jan2021 21:00. The patient received no treatment. The outcome of the events was recovered with sequelae on an unspecified date.
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| 75 | 2021-02-28 | nausea |
At 9:30 A.M. on 2/23, I noticed that I had a slight headache. My left arm was, as I had expected, p...
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At 9:30 A.M. on 2/23, I noticed that I had a slight headache. My left arm was, as I had expected, painful and red near the injection site. As the day progressed, I became aware of more reactions: chills, body aches, increasing headache, arm pain, and changes in my temperature (I usually have a temperature of 97.6, but measured 96.6 and in the evening, 100.4). I felt listless and nauseous by dinnertime. By the morning of 2/24, nothing was improved, so I took 2 Tylenol, which I repeated 7 hours later and 7 hours after that. By the morning of 2/25, I began feeling better and stopped the Tylenol. My symptoms gradually continued to improve through 2/28.
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| 75 | 2021-02-28 | nausea |
After 24 hours for about 6 hours and again 48 hours for about 6 hours: chills, body aches, headache,...
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After 24 hours for about 6 hours and again 48 hours for about 6 hours: chills, body aches, headache, dizzy, nausea; then after 9 days (February 25), same symptoms for about 6 hours.
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| 75 | 2021-03-01 | abdominal discomfort |
Transverse myelitis; bowel and urine issues; bowel and urine issues; she can't walk; numbness from h...
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Transverse myelitis; bowel and urine issues; bowel and urine issues; she can't walk; numbness from her toes up to her breast on the left side and numbness from her toes to her groin on the right side; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Jan2021 at 13:00 at single dose into right arm for COVID-19 immunisation at the age of 75-year-old. Lot number was EL8982. Medical history was unknown and concomitant medications included blood pressure pills and cholesterol pills and vitamins. On 24Jan2021, the patient experienced transverse myelitis; the patient was hospitalized due to the event (hospitalization dates from 24Jan2021 to 7Feb2021; emergency room since 24Jan20211 noon). Consumer stated that when she was in the hospital, she was on heavy doses of steroids intravenous (IV) for 5 days. Blood work at the hospital was normal. Consumer left the hospital to go to the rehab facility on 30Jan2021, and then consumer left the rehab facility on 07Feb2021. Consumer stated that she could not walk. Consumer had complete numbness from her toes up to her breast on the left side and numbness from her toes to her groin on the right side. Consumer stated that she was still having issues with dragging her left leg, and with rehab, she was finally getting back some feeling, the numbness was still there but she was having bowel and urine issues. Consumer stated that her issues have somewhat improved with the help of rehab. The patient was recovering from the events.
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| 75 | 2021-03-01 | difficulty swallowing |
Started coughing one week after receiving vaccine. Then woke up next morning with sore throat, "coul...
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Started coughing one week after receiving vaccine. Then woke up next morning with sore throat, "couldn't swallow." The symptoms "wouldn't let up" then patient reports by Saturday Feb 20, she felt "washed out," couldn't breathe, lost all energy, and had a RA attack. Her knees are still throbbing today.
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| 75 | 2021-03-01 | nausea | Sever pain in arm at injection site. Also nausea & weakness. |
| 75 | 2021-03-02 | decreased appetite, nausea |
it showed a "CRP value" of 11.5 which is usually below 0.29 which shows inflammation; loss of appeti...
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it showed a "CRP value" of 11.5 which is usually below 0.29 which shows inflammation; loss of appetite; Nausea; breathing problems; mild fever; Muscle ache; Joint ache; Rapid heart rate up to 130; Itchy skin; roof of mouth itching; eyes were also really sore; This is a spontaneous report from a contactable Other HCP (patient). A 75-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN6201), via an unspecified route of administration in the right arm on 11Feb2021 at single dose for COVID-19 immunisation. Medical history included ongoing asthma initially diagnosed at 21 years old, ongoing arthritis diagnosed 10-15 years before but she thinks she had it since she was 35, multiple joint replacements, past pneumonia. The patient's concomitant medications were not reported. The patient previously received methotrexate 25mg a week orally for arthritis but she quit taking it about 3 months before in preparation of getting the vaccine. The patient previously received the first dose of bnt162b2 on unspecified date (lot EL8982) at single dose for COVID-19 immunisation in the right arm. The patient experienced mild fever on 12Feb2021 with outcome of recovered on 14Feb2021, roof of mouth itching on 11Feb2021 with outcome of recovered on 11Feb2021, muscle ache on 12Feb2021 with outcome of recovered on 12Feb2021, joint ache on 12Feb2021 with outcome of recovering, breathing problems on 12Feb2021 with outcome of recovering, rapid heart rate up to 130 on 12Feb2021 with outcome of recovering, itchy skin on 11Feb2021 with outcome of recovered on 11Feb2021, it showed a "crp value" of 11.5 which is usually below 0.29 on 15Feb2021 with outcome of unknown, nausea on 12Feb2021 with outcome of recovered on 13Feb2021, loss of appetite on 13Feb2021 with outcome of recovered on 13Feb2021, eyes were also really sore on 11Feb2021 with outcome of recovered on 15Feb2021. An EKG performed on 15Feb2021 as pending results. The event of breathing problems was serious due to disability. The events mild fever, roof of mouth itching, muscle ache, joint ache, rapid heart rate up to 130 and itchy skin were medically significant. The patient reported that initially, the roof of her mouth started itching. It literally happened as soon as she had the vaccine. She took a Benadryl. She didn't have a skin irruption, but did have itchy skin. The next day, she had a low grade fever. She had muscle and joint aches. She had no rash, but a little nausea. She had breathing problems. She had asthma issues and wheezing after the vaccine. That is how she described her breathing issues. She had a rapid heart rate. It went up to 130. It could of been because of fever, her breathing, or pain. There was a period of days then it resolved. On 15Feb2021, she feels almost human. She had routine arthritis lab drawn on 15Feb2021. They showed a CRP level of 11.5 which shows inflammation. She normally was below 0.29 which was within normal limits. That was an extreme difference. That was a lot of inflammation. The patient had to get her nebulizer out to breathe. She has taken Tylenol a couple of times. Her lab work was essentially normal. The CBC and chemical panel was okay. The patient thoughts the fever was important because she has been immunocompromised for years by Methotrexate. She has had pneumonia before with no fevers. Her eyes were also really sore. They bothered her. She already had to use eye drops. That was 11Feb2021 it was gone on 15Feb2021 but it kind of lasted a few days. Her muscles were better, but her joints still hurt some. But her joints always hurt some. She has had multiple joint replacements. The muscles in her legs were severe Friday and Saturday. Her muscles aren't hurting now, but her joints were but that was kind of normal. Her peak flow was way down on 14Feb2021. It was at 250. She did finally get it up to 350 by using her nebulizer. Her best effort normally is 450. Her peak flow was down quite a bit. She has been having breathing changes for a year. They were not sure what it was about. It could be an acute episode of something. On unknown date (next morning as reported), her pulse was 90-100. Now her heart rate was only elevated with activity. Her heart rate was down in the 70s, but when moving it was in the low 100s. With activity it was still up. It was hanging out in the 70s except exercising. She considers walking across the room exercising. All her other labs were in within normal limits. The patient wanted to know if the inflammatory response was secondary to the vaccine.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 75 | 2021-03-02 | nausea |
AFib; Tingling sensation maybe her sinuses; Headache; Sore throat; Upper chest pain; aches (clarifie...
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AFib; Tingling sensation maybe her sinuses; Headache; Sore throat; Upper chest pain; aches (clarified as body or muscle ache in her arm or leg that occurred occasionally); aches (clarified as body or muscle ache in her arm or leg that occurred occasionally); Nausea; Heart pounding; Lightheadedness; tingling feeling below her neck on the flat area of her upper chest; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on the left arm on 28Jan2021 11:00 at a single dose for COVID-19 immunisation. Medical history included Afib (diagnosed about 4-5 years ago) and stress. There were no concomitant medications. It was reported that when she got her first COVID-19 Vaccine, her arm didn't hurt, but she had a headache, sore throat, an upper throat and chest type of thing, aches (clarified as body or muscle ache in her arm or leg that occurred occasionally), a little nausea, heart pounding, and lightheadedness on an unspecified date in Feb2021. She said she has AFib (atrial fibrillation) on an unspecified date. She said she is scheduled to get her second COVID-19 Vaccine shot next Monday (22Feb2021), and wanted to know if her side effects are going to be worse. She clarified that her upper throat and chest type thing to be a tingling feeling below her neck on the flat area of her upper chest on an unspecified date in Feb2021. She said she spoke with her doctor on a video call. She said her doctor said her tingling sensation would not be from the COVID-19 Vaccine shot, and the tingling sensation maybe her sinuses on an unspecified date. She said her doctor put her on antibiotics for 10 days (prescribed Cephalexin 500mg capsules, twice a day for 10 days. She said she started the Cephalexin 500mg capsules on 05Feb2021 and finished the prescription yesterday, 15Feb2021. She said the Cephalexin 500mg capsules were dispensed in a pharmacy bottle). The patient stated that she has no other medical conditions, except stress. She said she and her husband have been quarantined, and the quarantine has felt like the longest 2 weeks of her life. It was reported that the patient still gets heart palpitations. She said the other side effects lasted 5-7 days, and improved during that time. She said the side effects have all resolved with the exception of the heart palpitations. The event atrial fibrillation was assessed as serious (medically significant). The outcome of the event heart pounding was not recovered, while recovered on an unspecified date in Feb2021 for the rest of the events.
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| 75 | 2021-03-02 | nausea |
Extreme tiredness; nausea; feeling like I was run over by a truck; chills; headache; weakness; This ...
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Extreme tiredness; nausea; feeling like I was run over by a truck; chills; headache; weakness; This is a spontaneous report from a contactable consumer (patient). A 75-year-old non-pregnant female patient received first dose BNT162B2 (Solution for injection, Lot number: EL9264) via an unspecified route of administration on 31Jan2021 16:00 at single dose in right arm for covid-19 immunisation. Medical history included breast cancer and hodgkin Lymphoma. Concomitant medication included simvastatin, vitamin d nos. The patient had extreme tiredness, nausea, feeling like I was run over by a truck, chills, headache, weakness on 01Feb2021 at 13:00 pm. The most recent COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the adverse event. The outcome of the events was recovering.
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| 75 | 2021-03-03 | nausea |
dizziness, lightheaded, chills in head and body, nausea, elevated blood pressure, frightening odd fe...
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dizziness, lightheaded, chills in head and body, nausea, elevated blood pressure, frightening odd feeling all over, fatigue
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| 75 | 2021-03-03 | stomatitis |
Pfizer-BioNTech COVID-19 Vaccine EUA: Experienced SORE on roof of mouth (left side), painful and las...
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Pfizer-BioNTech COVID-19 Vaccine EUA: Experienced SORE on roof of mouth (left side), painful and lasted for one week. Also upper GUMS on both sides of mouth were painful and lasted for 7 to 10 days. No treatment administered. Problems have resolved themselves.
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| 75 | 2021-03-05 | difficulty swallowing |
45 minutes after the injection symptoms started as tingling of lips, then tingling of tongue, then ...
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45 minutes after the injection symptoms started as tingling of lips, then tingling of tongue, then my throat felt dry, hard to swallow. I drank fluids thinking that might help. The symptoms got stronger in a few hours when my heart beat was irregular and only 51-57bpm. I laid down and took my blood pressure which was normal and heart beat became normal. Later I could tell my lips and tongue were swollen. I live alone and had no way to get to the hospital so late at night . I called my primary doctor to see if I could be a walk-in and the nurse said to go to the ER immediately. my neighbor brought me. There I was given steroids and Benadryl and monitored for a couple of hours. I am on prednisone for 5 days total and was told to take two Benadryl if symptoms return. I will take it now, because my throat still feels funny.
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| 75 | 2021-03-06 | abdominal discomfort |
After about 5 days from second vaccination, went to the hospital with bowel problem; they required a...
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After about 5 days from second vaccination, went to the hospital with bowel problem; they required a urine analysis which showed I had "loads of white cells" and was given Bactrum. I have had no UTI for at least 25 years. In the meantime, I had chills, fever, and by Thursday, my temperature was 101 degrees. if I have an abundance of white blood cells, could the antigens have caused the UTI?
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| 75 | 2021-03-06 | nausea, abdominal pain upper | extreme fatigue for one day, nausea and stomach pain for one day |
| 75 | 2021-03-07 | diarrhea |
Cold sweat; Within 15 minutes, started itching really bad / Itchy in ears, scalp, neck, chest, arms;...
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Cold sweat; Within 15 minutes, started itching really bad / Itchy in ears, scalp, neck, chest, arms; Headache; Diarrhea; Chills; Tenderness where the shot area is; Joint pain; Really bad flu; A little bit of a rash from it because my skin is all red from itching; A little bit of a rash from it because my skin is all red from itching; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EN5318), via an unspecified route of administration on 02Feb2021 (at the age of 75-years-old) as a single dose for COVID-19 immunization. Medical history included high cholesterol and eye disorder. Concomitant medication included atorvastatin, ubidecarenone (COQ-10), colecalciferol (VITAMIN D3), cyanocobalamin (VITAMIN B12), monascus purpureus (RED YEAST RICE) and unspecified OCUVITE for the eyes. On 02Feb2021 at 14:30, within 15 minutes of the vaccination, the patient was itching really bad (itchy in the ears, scalp, neck, chest, arms). The patient was kept in observation after the vaccination for an hour and was treated with diphenhydramine (BENADRYL) which did not seem to help. The patient drover home and went to bed. Her physician suggested that she see an allergist. The allergist was not sure what was in the vaccine and requested the patient ask her doctor for another referral. On 02Feb2021, the patient also experienced headache; diarrhea; chills; tenderness where the shot area was. On 03Feb2021, the patient woke up with cold sweats, like cold wet perspirations and chills again. On an unspecified date in Feb2021, the patient experienced joint pain and felt like she had a really bad flu, developed a little bit of a rash because the skin was all red from the itching, which she couldn't stop. The patient reported that she was treated for the events with diphenhydramine and paracetamol (TYLENOL). She questioned whether there were other reports of itchiness. The clinical outcome of "within 15 minutes, started itching really bad / Itchy in ears, scalp, neck, chest, arms", headache, diarrhea, chills, cold sweat was not resolved; while "tenderness where the shot area is", joint pain, really bad flu, "a little bit of a rash from it because my skin is all red from itching" was unknown.
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| 75 | 2021-03-08 | diarrhea, nausea, vomiting | Fever, intractable nausea and vomiting, fatigue, headache, body aches and diarrhea |
| 75 | 2021-03-08 | diarrhea |
PATIENT AWAKENED DURING NIGHT WITH EXTREME CHILLS, HEADACHE, FATIGUE, FREQUENT DIARRHEA, URINARY FR...
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PATIENT AWAKENED DURING NIGHT WITH EXTREME CHILLS, HEADACHE, FATIGUE, FREQUENT DIARRHEA, URINARY FREQUENCY. THIS HAS NOT RESOLVED OR IMPROVED IN 6 DAYS AFTER VACCINATION #2
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| 75 | 2021-03-08 | nausea, vomiting | NAUSEA/VOMITING BEGAN 03/05/2021 IN THE PM |
| 75 | 2021-03-08 | nausea |
Fever of 103, chills, body aches, headache, nausea, several large, red welts (hives??). Lasted about...
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Fever of 103, chills, body aches, headache, nausea, several large, red welts (hives??). Lasted about 40 hours, symptoms decreasing after about 30 hours.
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| 75 | 2021-03-08 | nausea |
VR developed perioral tingling and nausea appx 15 minutes after injection. BP: 140/90, HR 70, SP02 >...
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VR developed perioral tingling and nausea appx 15 minutes after injection. BP: 140/90, HR 70, SP02 >94%. Symptoms resolved after appx. 10 minutes. The VR declined EMS services.
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| 75 | 2021-03-09 | nausea, diarrhea |
patient had 2nd vaccine on 2/26/21. she called the office on 3/1/21 and stated that she had hives/we...
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patient had 2nd vaccine on 2/26/21. she called the office on 3/1/21 and stated that she had hives/welts with extreme itching. she states she had diarrhea and was nauseous. she was taking Benadryl and Caladryl lotion for the itchiness. she stated at that time she was feeling better as the day went on. she called back the office on 3/3/21 and stated that she still had the hives and itching and that the Benadryl helped. she also stated that she was not willing to leave the house to go out to the pharmacy for any meds that might have been prescribed.
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| 75 | 2021-03-09 | nausea |
Nausea for 4 days to this point, individual "is never nauseous" and has been since the vaccine; This...
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Nausea for 4 days to this point, individual "is never nauseous" and has been since the vaccine; This is a spontaneous report from a contactable consumer. A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 02Feb2021 at single dose for COVID-19 immunisation. Medical history included thyroid imbalance, high blood pressure. The patient had no known allergies. No other vaccine was received in four weeks. No COVID prior vaccination. The patient's concomitant medications were not reported. The patient experienced nausea for 4 days to this point, she "is never nauseous" and had been since the vaccine on 02Feb2021. No treatment was received for event. No COVID tested post vaccination. The outcome of event was not recovered. Information on lot/batch has been requested.
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| 75 | 2021-03-09 | nausea |
nausea, muscle and joint aches, chill, headache, insomnia, dizziness, itchiness, swollen glands, bra...
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nausea, muscle and joint aches, chill, headache, insomnia, dizziness, itchiness, swollen glands, brain fog, rosacea,
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| 75 | 2021-03-11 | abdominal discomfort | Mild headache; fatigue; joint aches; unsettled stomach; overall not well that lasted for 7 days |
| 75 | 2021-03-11 | nausea, vomiting | Nausea, vomiting, fever, generalize weakness, dehydration |
| 75 | 2021-03-14 | nausea, diarrhea |
Chills; Nausea; Diarrhea; This is a spontaneous report from a non-contactable consumer (patient). A ...
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Chills; Nausea; Diarrhea; This is a spontaneous report from a non-contactable consumer (patient). A 75-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Feb2021 12:00 at single dose at left arm for covid-19 immunization. Medical history included TAVR, blood pressure, acid reflux from an unknown date and unknown if ongoing. Concomitant medications included lisinopril for blood pressure, atorvastatin, omeprazole for acid reflux, hydrochlorothiazide for water pill, spironolactone; all ongoing. The patient experienced chills, nausea, diarrhea all on 09Feb2021 with outcome of recovering. These symptoms were still there, but they're almost gone. Stated it seemed like they all came on together. No additional vaccines administered on the same date of the Pfizer vaccine considered as suspect. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Stated she had never had a reaction after previous vaccinations. No follow-up attempts are possible. Information about Lot/batch number cannot be obtained. No further information is expected.
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| 75 | 2021-03-14 | nausea |
Started out Friday, 3/12/21 around 2PM, headache, got worse as evening came, next morning, Saturday ...
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Started out Friday, 3/12/21 around 2PM, headache, got worse as evening came, next morning, Saturday 3/13/21, sore arm, head felt like someone stuffed it, afraid to take any medication or to eat anything. Felt like throwing up all day, but never did. Very tired all day, slept off and on half the day on the couch. Started to feel a little better around 8PM 3/13/21. Fever, usually my temperature is 97.7 or 97.8 but at one time it was 101. Very week and drained. Sunday 3/14/21, felt much better but head still hurt a little. Monday, 3/15/21 head hurt a little in the morning, but was okay by around 9AM. Pretty much back to normal after that.
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| 75 | 2021-03-17 | decreased appetite |
Fever, body aches, fatigue loss of appetite; treated with ibuprofen and Oxycodone IR 5mg tab CII; re...
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Fever, body aches, fatigue loss of appetite; treated with ibuprofen and Oxycodone IR 5mg tab CII; rest (slept for almost 48 hours) Symptoms, except fatigue, pretty much gone in 48 hours
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| 75 | 2021-03-17 | decreased appetite |
The next day I had joint aches, fever (100.6), tiredness, sleepiness and no appetite. It lasted one...
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The next day I had joint aches, fever (100.6), tiredness, sleepiness and no appetite. It lasted one full day.
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| 75 | 2021-03-17 | nausea, abdominal pain |
Had chills all day of vaccine One week later chills on and off mot severe as first day Developed pai...
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Had chills all day of vaccine One week later chills on and off mot severe as first day Developed pain on rt side abdomen a week later which went from rt side abdomen now I. Hip the pain is constant and a week later nauseas in the morning
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| 75 | 2021-03-17 | nausea, vomiting |
Nausea, emesis, headach, exacerbation of chronic low back pain. The patient explains that she has be...
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Nausea, emesis, headach, exacerbation of chronic low back pain. The patient explains that she has been experiencing the nausea since her COVID-19 vaccination
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| 75 | 2021-03-18 | abdominal discomfort |
6 hours after 2nd dose of vaccine I could feel my body starting to react. Aches and pains increased...
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6 hours after 2nd dose of vaccine I could feel my body starting to react. Aches and pains increased as the time went on. I went to bed and around 12 hours after the injection I got a headache that was unbearable. It felt like someone was hitting my head with an ax. The pain was excruciating. I went through the night with the pain feeling like my head would explode. In the morning I was totally exhausted and my body hurt all over. I took Tylenol and went back to bed. Put warm cloths on my head and face. My sinus hurt, my teeth hurt. my throat hurt. my eyes hurt. Awful!!! Spent the entire day in bed. I continued taking Tylenol every 6 hours. It did help a little. By Friday I was seeming to feel a little better. Still have mild headache and body aches and stomach upsets; but better than the first 24-36 hours. Hoping to continue to improve each day. Never expected any side effects as severe. Most people said sore arm and feeling tired. I do hope the worse is over.
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| 75 | 2021-03-18 | abdominal pain upper, flatulence, constipation |
Unable to sleep; Gas from both ends; Stomach cramps; Constipation; Her injection arm is sore; This i...
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Unable to sleep; Gas from both ends; Stomach cramps; Constipation; Her injection arm is sore; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9264), via an unspecified route of administration, administered in left arm on 11Feb2021 15:30 as single dose for COVID-19 immunisation (because of the pandemic and she is 75). Medical history included being diabetic. Concomitant medications included warfarin and varicella zoster vaccine taken for an unspecified indication, start and stop date were not reported. The patient previously had a flu shot back in Oct2020 and experienced sore at the injection site. The patient was unable to sleep last night due to stomach cramps and constipation. It has been horrible. Worst part was gas from both ends. The events began 9PM or a little earlier on 11Feb2021. The patient also reported that her injection arm was sore on Feb2021. This is the first time she has had a reaction like this and not been able to sleep. Asked if she should drink some lemon water, take a laxative, or what to do. Advised the patient to follow up with primary care physician for treatment recommendations. The patient underwent lab tests and procedures which included blood pressure: 124/78 and A1C: 5.9 on an unspecified date; international normalised ratio (INR): 424 on 08Feb2021. The outcome of the event her injection arm was sore was unknown and not recovered for the rest of the events.
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| 75 | 2021-03-18 | abdominal pain, appendicitis |
I started to have abdominal pain after I'd gone to bed on 2/26/2021. I went to the ER on 2/27/2021 ...
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I started to have abdominal pain after I'd gone to bed on 2/26/2021. I went to the ER on 2/27/2021 and was diagnosed with appendicitis. I was operated on the morning of 2/28/2021- appentectomy.
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| 75 | 2021-03-21 | nausea |
Light headedness and Nausea. Reclined patient provided 4L O2 via NC, dizziness resolved. Slight naus...
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Light headedness and Nausea. Reclined patient provided 4L O2 via NC, dizziness resolved. Slight nausea upon leaving, felt much better. Friend provided ride home. Pulse was 82/regular
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| 75 | 2021-03-22 | diarrhea |
Extremely tired kept falling asleep all day of shot; slept thru the night and most of next day; hive...
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Extremely tired kept falling asleep all day of shot; slept thru the night and most of next day; hives on left side of neck (received shot in left arm) diarrhea all day after shot; arm slightly sore. Did not feel sick; just had these reactions.
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| 75 | 2021-03-23 | difficulty swallowing |
Approx. 12 hours after receiving a second Covid shot my wife experienced difficulty swallowing, the ...
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Approx. 12 hours after receiving a second Covid shot my wife experienced difficulty swallowing, the sensation that her throat was closing and a very rapid heartbeat.
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| 75 | 2021-03-24 | nausea |
all face including eyes swollen and red; all face including eyes swollen and red; skin got creepy, d...
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all face including eyes swollen and red; all face including eyes swollen and red; skin got creepy, dry, itchy; injection site pain and was swollen a lot; little dizziness; nausea; Muscle pain more on back side of shoulder towards neck-unbearable pain; headache; neck disfigured; rash; injection site pain; brain fog big time - disorientated, felt like brain getting damage; I'm desperate; This is a spontaneous report from a contactable consumer (patient). A 75-years-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Formulation: solution for injection, Lot no: EN5318) via intramuscular at left arm on 19Feb2021 at 03:10 (at the age of 75-years-old) at single dose for covid-19 immunisation (at hospital). Patient medical history not reported. Concomitant medications included levothyroxine; 0.075 mg once daily for hypothyroid since 20 years; ongoing and trazodone 100 mg 1 tab daily since 20 years; ongoing. On 19Feb2021 the patient experienced injection site pain and was swollen a lot, little dizziness, nausea, muscle pain more on back side of shoulder towards neck-unbearable pain, headache, all face including eyes swollen and red, all face including eyes swollen and red, skin got creepy, dry, itchy, brain fog big time - disorientated, felt like brain getting damage, she was desperate, skin got creepy, dry and itchy. my face and neck was disfigured that don't want my children and grant children see my face. Rash-swelling, itchy and flaky skin, got a little better on 01Mar, but I still have creepy skin, flackey, itchy around eye and eyelids were swollen and dry and felt like have stones rolling in my eyes and my brain fog was very bad. I want to know if my skin will ever get better. Patent took vit-d and all the vit. Covid. Patient received treatment as OTC, Tylenol, ibuprofen, aleve. No covid prior vaccination. The reporter reported seriousness criteria as non-serious. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 75 | 2021-03-25 | vomiting, diarrhea |
symptoms started 2 days after getting the COVID vaccine having body aches, cough, headache, fatigue,...
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symptoms started 2 days after getting the COVID vaccine having body aches, cough, headache, fatigue, diarrhea and vomiting. Symptoms are getting worse and not better. Cough is productive thick white sputum with SOB. It has been 18 days with symptoms that are not improving. Scheduled appointment with doctor for further treatment. Canceled appointment for 2nd COVID vaccine
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| 75 | 2021-03-30 | diarrhea |
bleeding; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 75-year-ol...
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bleeding; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration, administered on the left arm on 25Feb2021 at 11:00 at a single dose for COVID-19 immunisation. Medical history included anxiety, cholesterol was getting high, blood pressure is a little high, depression, asthma, arthritis and bowel problem. Concomitant medications included venlafaxine hydrochloride (EFFEXOR) taken for depression from 1999 and ongoing; ongoing alprazolam (XANAX) taken for anxiety; ongoing aripiprazole (ABILIFY) taken for anxiety and depression; ongoing mirtazapine; ongoing diclofenac taken for arthritis; ongoing atorvastatin calcium (LIPITOR) taken for Cholesterol was getting high; ongoing enalapril taken since blood pressure is a little high at times; fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for asthma. On 28Feb2021, without any changes to her diet; she started having diarrhea and had it for 7 days. Inquiring as to whether it was a possible side effect from vaccine. Stated diarrhea lasted until the morning of 06Mar2021 and ended with bleeding on an unspecified date. Stated she has recovered and was back to normal. She did not have any labs, testing or treatments but was seeing a new Gastroenterologist on 20Apr2021 due to this event. She doesn't know what the bowel problem was; that this happened sometimes but this was the first time ended in bleeding. Had colonoscopy 30Nov2020 and was fine, no polyps. The facility where the vaccine was administered was in a Local (pharmacy name withheld) Pharmacy. There were no additional vaccines administered on same date of Pfizer suspect. The events did not require a visit to physician office or Emergency Room. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the event diarrhea was recovered on 06Mar2021 and unknown for the other event. Information on the lot/batch number has been requested.
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| 75 | 2021-03-30 | nausea |
no arm pain at injection site until following morning; my face became warm and beet red; my face bec...
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no arm pain at injection site until following morning; my face became warm and beet red; my face became warm and beet red; experienced incredible thirst; intermittent nausea and lethargy; intermittent nausea and lethargy; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient (non pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9269), via an unspecified route of administration, in Arm Left on 02Feb2021 12:00 (12:00 PM) (age at vaccination 75 Years) as single dose for covid-19 immunisation. Patient was not pregnant at time of vaccination. Medical history included known allergies to penicillin, NSAIDS, doxycycline, lidocaine and prednisone. Concomitant medication(s) included atorvastatin at 10 mg; calcium citrate (CITRACAL [CALCIUM CITRATE]); bifidobacterium infantis, lactobacillus acidophilus (PROBIOTIC [BIFIDOBACTERIUM INFANTIS;LACTOBACILLUS ACIDOPHILUS]); ubidecarenone (COQ-10) and Magn (as reported). Pateint reported that "on 02Feb2021 at 12:00 PM, Shortly after receiving first dose my face became warm and beet red, didn't realize until I'd gotten to my car and taken off my mask, at which time I also experienced incredible thirst. Other symptoms that day (02Feb2021), Wednesday and today have been intermittent nausea and lethargy, no arm pain at injection site until following morning (03Feb2021), okay now." No treatment was received for the events. This case is reported as non-serious. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Outcome "no arm pain at injection site until following morning" was recovered while other events was recovering. No follow-up attempts are possible. No further information is expected.
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| 75 | 2021-03-30 | nausea |
Lung tightness with burning and pain/lungs were tight; Lung tightness with burning and pain; Headach...
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Lung tightness with burning and pain/lungs were tight; Lung tightness with burning and pain; Headache; nausea; Muscle heaviness; fatigue; brain fog(poor concentration and focus); brain fog(poor concentration and focus); general malaise; Increased bowel movements daily; This is a spontaneous report from a contactable pharmacist (Pharmacist). A 75-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: El8982), via an unspecified route of administration, administered in Arm Left on 27Jan2021 10:30 as single dose for covid-19 immunisation at Health Clinic or administration facility. Medical history included gastrooesophageal reflux and osteoarthritis from an unknown date and unknown if ongoing. Concomitant medication included pravastatin taken for an unspecified indication, famotidine, ascorbic acid, betacarotene, colecalciferol, folic acid, minerals nos, retinol, tocopheryl acetate, vitamin b nos (CENTRUM [ASCORBIC ACID;BETACAROTENE;COLECALCIFEROL;FOLIC ACID;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS]), cyanocobalamin (B12), ergocalciferol (VIT D). The patient previously took biaxin and experienced drug hypersensitivity. On 27Jan2021 20:00, the patient experienced lung tightness with burning and pain/lungs were tight, headache, nausea, muscle heaviness, fatigue, brain fog (poor concentration and focus), general malaise and increased bowel movements daily. These symptoms lasted for 7 days. Two of the days my lungs were tight but I did not have shortness of breath. Nausea was everyday. Increased bowel movements daily. I am concerned that these effects lasted for 7 days. Does this put me at risk for serious side effects after the 2nd dose. The action taken in response to the event for BNT162B2 was not applicable. The outcome of events was recovering.
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| 75 | 2021-04-03 | nausea, diarrhea |
All the symptoms of COVID minus the chest congestion/does not know if she might have caught COVID-19...
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All the symptoms of COVID minus the chest congestion/does not know if she might have caught COVID-19; All the symptoms of COVID minus the chest congestion/does not know if she might have caught COVID-19; her temperature went up to 102 degrees; terrible joint pains; she could not stay awake at all; diarrhea; nauseousness; headache; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration, administered in the left arm on 12Feb2021 08:30 as a single dose for COVID-19 immunisation. Medical history included dental care from an unknown date and unknown if ongoing. No concomitant drugs were reported. The patient previously received penicillin as prophylaxis prior to dental care. The patient previously received the first dose of BNT162b2 in Jan2021 (about 3 weeks prior to second dose) (Lot Number: unknown) via an unspecified route of administration in the upper left arm for COVID-19 immunisation. The patient was administered her second dose of BNT162b2 on 12Feb2021. She initially had no reaction. Then on 12Mar2021, (about 3 weeks after second dose of BNT162b2), the patient experienced all symptoms of COVID minus chest congestion, described as temperature went up to 102 degrees; terrible joint pains; could not stay awake at all; diarrhea; nauseousness; headache. Patient called her doctor and thought she could get COVID test, but the doctor said she does not need it and told her not to worry. They automatically diagnosed the patient with late side effects. Doctor thinks it is late side effects of BNT162b2 because there are cases where the doctor has seen 3 weeks to a month out of people having side effects. She has had no known exposure to any infected persons; She has been isolating 99 percent of the time since this started. She went out a couple of times to the store but she was masked and did not get near anyone; The patient does not know if she might have caught COVID-19 infection and wonders if with these event symptoms, she might have caught a milder case of COVID. The patient reported that right now her temperature was 99.5 degrees. She did not use any antipyretic. The patient was recovering from the event, temperature went up to 102 degrees. Outcome of the events, all symptoms of COVID minus chest congestion/does not know if she might have caught COVID-19, temperature went up to 102 degrees; terrible joint pains; could not stay awake at all; diarrhea; nauseousness; headache was unknown. Information about lot/batch number has been requested.
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| 75 | 2021-04-04 | vomiting, nausea, diarrhea |
Patient called PCP office 3/5 w/ c/o N/V/D, weakness and lightheaded when she stood up. Was advised ...
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Patient called PCP office 3/5 w/ c/o N/V/D, weakness and lightheaded when she stood up. Was advised to hold blood pressure medication. On 3/8, was feeling much worse and called 911. Upon arrival (8:55), patient A&O x 4 with poor oxygen saturation (O2: 88%). Given nebulized albuterol/ipratropium. BG: 247mg/dl. Patient has episode of dry heaving after which she vagaled down with HR in the 40s. Recovered on her own. Once the nebulizer treatment ended, she was place on nasal O2 at 3 liters/minutes. Given 4mg ondansetron. Lost consciousness and respirations became agonal. Pt was bagged via BVM and noted to be in PEA. CPR initiated, including intubation. Given 1mg epinephrine. NSR obtained after two rounds of CPR. Pt arrested again shortly after arrival to ED. ACLS initiated once more. Patient expired at 10:40 am.
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| 75 | 2021-04-06 | difficulty swallowing |
difficulty breathing when laying down; Constant "fluttering" in chest for 2 - 3 hours; difficulty ta...
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difficulty breathing when laying down; Constant "fluttering" in chest for 2 - 3 hours; difficulty taking medication in large capsules; This is a spontaneous report received from a contactable consumer (patient). This 75-year-old female patient, did not Pregnant at the time of vaccination, received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose (lot EL9269) on 06FEB2021 at single dose on Right arm for COVID-19 immunization. Medical history included ARVD, Breast Cancer, Carcinoid Syndrome, Autoimmune Problems, Asthma. Allergies included Several meds and seasonal respiratory. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. Concomitant medications were not reported. Event started on 06Feb2021 07:45 PM, several hours after vaccination, constant "fluttering" in chest for 2 - 3 hours, difficulty breathing when laying down, difficulty taking medication in large capsules. No treatment received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was Recovered. Information on Lot/Batch number was available. Additional information has been requested.
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| 75 | 2021-04-16 | vomiting |
resident turned on call light, emesis X1 right sided weakness, slurred speech. Emesis X1 when EMS at...
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resident turned on call light, emesis X1 right sided weakness, slurred speech. Emesis X1 when EMS at facility Sent to ER 3/5/2021I63.532: CEREB INFRC D/T UNSP OCCLS OR STENOS OF LEFT POST CEREB ART, N31.9: NEUROMUSCULAR DYSFUNCTION OF BLADDER, UNSPECIFIED, R47.01: APHASIA, Z86.16: PERSONAL HISTORY OF COVID-19 3/8/2021 J44.9: CHRONIC OBSTRUCTIVE PULMONARY DISEASE, UNSPECIFIED
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| 75 | 2021-04-17 | retching |
Gagging; Feels tired and sleepy all the time; Feels tired and sleepy all the time; Arm was really so...
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Gagging; Feels tired and sleepy all the time; Feels tired and sleepy all the time; Arm was really sore; Some choking; Anxiety; Cough during treatment; This is a solicited report (MARKETING PROGRAM NAME NOT AVAILABLE) based on the information received by Pfizer pharmacy. A contactable 75-year-old female consumer (patient)received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation; and treprostinil sodium, via inhalation from 12Feb2021 (Batch/Lot number was not reported) to an unspecified date and at 18-54 ug, 4x/day, via inhalation from an unspecified date (Batch/Lot number was not reported), at 36 ug, 4x/day for pulmonary arterial hypertension. Medical history included ongoing anxiety. The patient's concomitant medications were not reported. In Feb2021, the patient experienced event of cough during treatment. In 2021, the patient experienced event of gagging (retching). On 04Mar2021, the patient experienced event of anxiety; related it to going to the physician appointment. An additional dosage regimen of 36 ug (6 breaths), qid via IH route was added to Tyvaso. The patient reported that coughing (previously reported as cough) and gagging had improved after the treatment. The patient's current IH Tyvaso dose was 6 breaths four times a day. On 04 Mar 2021, 2 weeks 6 days after initiating IH Tyvaso, the patient had anxiety and related it to going to the physician appointment. The patient had reported ongoing anxiety since childhood. In 2021, the patient experienced the event of some choking. In 2021, the patient experienced the events of feels tired and sleepy all the time and arm was really sore (pain in extremity). The patient felt tired and sleepy all the time. Her arm was really sore and she was tired and sleepy. The outcome of the event cough and gagging was recovering while the outcome of the rest of the events was unknown. The action taken in response to treprostinil sodium for the events was unknown. An unspecified treatment was given to the patient for the event cough and gagging. The reporter assessed the causal relationship between the IH Tyvaso and the event of cough as possible. The reporter did not provide causality for the events of retching, choking, anxiety, fatigue, somnolence, and pain in extremity. No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of choking,cough,gagging,and other events cannot be excluded but also contributory effect from other suspect drug TREPOSTINIL SODIUM. consider also possible contributory effects from patient's medical history and concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 75 | 2021-04-18 | nausea, vomiting |
Symptoms started around the day of vaccination which included cough and shortness of breath. Develop...
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Symptoms started around the day of vaccination which included cough and shortness of breath. Developed nausea and vomiting which led to presentation to emergency department. Patient was admitted and treated for COVID-19 infection.
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